Monitoring Editor: Jo C Dumville, Trish A Gray, Catherine J Walter, Catherine A Sharp, Tamara Page, Rhiannon Macefield, Natalie Blencowe, Thomas KG Milne, Barnaby C Reeves, Jane Blazeby, and Cochrane Wounds GroupUniversity of Manchester, Division of Nursing, Midwifery & Social Work, School of Health Sciences, Faculty of Biology, Medicine & Health, ManchesterUK, M13 9PL Show
Gloucestershire NHS Foundation Trust, Colorectal Surgery, Cheltenham General, Sandford Road, CheltenhamUK, GL53 7AN The Wound Centre, PO Box 3207, Blakehurst, SydneyNew South WalesAustralia, 2221 Royal Adelaide Hospital, Level 4, Margaret Graham Building, North Terrace, AdelaideAustralia, SA5000 University of Adelaide, Level 3, Eleanor Harrald Building, North Terrace, AdelaideAustralia, SA 5000 University of Bristol, University of Bristol, School of Social and Community Medicine, Canynge Hall, 39 Whatley Road, BristolUK, BS28 2PS University of Bristol, School of Clinical Sciences, Level 7, Bristol Royal Infirmary, Marlborough Street, BristolUK, BS2 8HW University of Bristol, Bristol Centre for Surgical Research, School of Social & Community Medicine, Canynge Hall, 39 Whatley Road, BristolUK, BS8 2PS Jo C Dumville, Email: . Author information Copyright and License information Disclaimer University of Manchester, Division of Nursing, Midwifery & Social Work, School of Health Sciences, Faculty of Biology, Medicine & Health, ManchesterUK, M13 9PL Gloucestershire NHS Foundation Trust, Colorectal Surgery, Cheltenham General, Sandford Road, CheltenhamUK, GL53 7AN The Wound Centre, PO Box 3207, Blakehurst, SydneyNew South WalesAustralia, 2221 Royal Adelaide Hospital, Level 4, Margaret Graham Building, North Terrace, AdelaideAustralia, SA5000 University of Adelaide, Level 3, Eleanor Harrald Building, North Terrace, AdelaideAustralia, SA 5000 University of Bristol, University of Bristol, School of Social and Community Medicine, Canynge Hall, 39 Whatley Road, BristolUK, BS28 2PS University of Bristol, School of Clinical Sciences, Level 7, Bristol Royal Infirmary, Marlborough Street, BristolUK, BS2 8HW University of Bristol, Bristol Centre for Surgical Research, School of Social & Community Medicine, Canynge Hall, 39 Whatley Road, BristolUK, BS8 2PS Jo C Dumville, Email: . Corresponding author.Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Surgical wounds (incisions) heal by primary intention when the wound edges are brought together and secured, often with sutures, staples, or clips. Wound dressings applied after wound closure may provide physical support, protection and absorb exudate. There are many different types of wound dressings available and wounds can also be left uncovered (exposed). Surgical site infection (SSI) is a common complication of wounds and this may be associated with using (or not using) dressings, or different types of dressing. To assess the effects of wound dressings compared with no wound dressings, and the effects of alternative wound dressings, in preventing SSIs in surgical wounds healing by primary intention. We searched the following databases: the Cochrane Wounds Specialised Register (searched 19 September 2016); the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library 2016, Issue 8); Ovid MEDLINE (including In‐Process & Other Non‐Indexed Citations, MEDLINE Daily and Epub Ahead of Print; 1946 to 19 September 2016); Ovid Embase (1974 to 19 September 2016); EBSCO CINAHL Plus (1937 to 19 September 2016). There were no restrictions based on language, date of publication or study setting. Randomised controlled trials (RCTs) comparing wound dressings with wound exposure (no dressing) or alternative wound dressings for the postoperative management of surgical wounds healing by primary intention. Two review authors performed study selection, 'Risk of bias' assessment and data extraction independently. We included 29 trials (5718 participants). All studies except one were at an unclear or high risk of bias. Studies were small, reported low numbers of SSI events and were often not clearly reported. There were 16 trials that included people with wounds resulting from surgical procedures with a 'clean' classification, five trials that included people undergoing what was considered 'clean/contaminated' surgery, with the remaining studies including people undergoing a variety of surgical procedures with different contamination classifications. Four trials compared wound dressings with no wound dressing (wound exposure); the remaining 25 studies compared alternative dressing types, with the majority comparing a basic wound contact dressing with film dressings, silver dressings or hydrocolloid dressings. The review contains 11 comparisons in total. Primary outcome: SSI It is uncertain whether wound exposure or any dressing reduces or increases the risk of SSI compared with alternative options investigated: we assessed the certainty of evidence as very low for most comparisons (and low for others), with downgrading (according to GRADE criteria) largely due to risk of bias and imprecision. We summarise the results of comparisons with meta‐analysed data below: ‐ film dressings compared with basic wound contact dressings following clean surgery (RR 1.34, 95% CI 0.70 to 2.55), very low certainty evidence downgraded once for risk of bias and twice for imprecision. ‐ hydrocolloid dressings compared with basic wound contact dressings following clean surgery (RR 0.91, 95% CI 0.30 to 2.78), very low certainty evidence downgraded once for risk of bias and twice for imprecision. ‐ hydrocolloid dressings compared with basic wound contact dressings following potentially contaminated surgery (RR 0.57, 95% CI 0.22 to 1.51), very low certainty evidence downgraded twice for risk of bias and twice for imprecision. ‐ silver‐containing dressings compared with basic wound contact dressings following clean surgery (RR 1.11, 95% CI 0.47 to 2.62), very low certainty evidence downgraded once for risk of bias and twice for imprecision. ‐ silver‐containing dressings compared with basic wound contact dressings following potentially contaminated surgery (RR 0.83, 95% CI 0.51 to 1.37), very low certainty evidence downgraded twice for risk of bias and twice for imprecision. Secondary outcomes There was limited and low or very low certainty evidence on secondary outcomes such as scarring, acceptability of dressing and ease of removal, and uncertainty whether wound dressings influenced these outcomes. It is uncertain whether covering surgical wounds healing by primary intention with wound dressings reduces the risk of SSI, or whether any particular wound dressing is more effective than others in reducing the risk of SSI, improving scarring, reducing pain, improving acceptability to patients, or is easier to remove. Most studies in this review were small and at a high or unclear risk of bias. Based on the current evidence, decision makers may wish to base decisions about how to dress a wound following surgery on dressing costs as well as patient preference. Dressings for the prevention of surgical site infection Review question This review aimed to assess whether use of different wound dressings (or leaving a wound exposed without a dressing) has an impact on the number of people who get wound infections following surgery where the wound is closed with stitches, staples, clips or glue. We also investigated whether different dressings resulted in less pain, less scarring or were more acceptable to patients and health professionals. Background Millions of surgical procedures are conducted globally each year. The majority of procedures result in wounds in which the edges are brought together to heal using stitches, staples, clips or glue; this is called 'healing by primary intention'. Afterwards, wounds are often covered with a dressing that acts as a barrier between it and the outside environment. One possible advantage of a dressing may be to protect the wound from infection (surgical site infection). Many different dressing types are available for use on surgical wounds. However, it is not clear whether one type of dressing is better than any other in preventing surgical site infection, or, indeed, whether it is better not to use a dressing at all. Study characteristics We conducted a review of all available, relevant evidence about the impact of dressings on the prevention of surgical site infections in surgical wounds healing by primary intention. This review examined data from 29 randomised controlled trials (which provide the most reliable evidence). These investigated the use of dressings in surgery that had a low risk of surgical site infection (clean surgery) and surgery with a higher risk (potentially contaminated surgery). Key results We found no clear evidence to suggest that one dressing type was better than any other at reducing the risk of surgical site infection, nor that covering wounds with any dressing at all reduced the risk of surgical site infection. Additionally, there was no clear evidence that any dressing type improves scarring, pain control, patient acceptability or ease of removal. Currently decision makers may opt to make decisions about whether and how to dress a wound based on patient and clinician preferences and dressing costs. Certainty of the evidence It is important to note that many trials in this review were small and the evidence was of low or very low certainty meaning that current information is uncertain. Assessed as up to date September 2016. Millions of surgical procedures are conducted around the world each year. The majority of procedures result in surgical wounds that will heal by primary intention. This is where wound edges are re‐approximated using sutures, staples, clips or glue, either alone, or in combination. Following wound closure, surgical wounds commonly leak fluid or blood within the first 24 hours and they are frequently covered with different types of dressing ‐ including glue‐as‐a‐dressing (tissue glue applied over a wound that has already been closed) ‐ to manage the exudate, provide wound protection and prevent possible external contamination that might lead to surgical site infection (SSI) and delayed healing. A study in the USA found that in over 750,000 episodes of surgical hospitalisation, 1% resulted in an SSI (de Lissovoy 2009), and similar estimates have been found in France (Astagneau 2009). However, such values are known to underestimate the levels of SSI by not considering those that develop outside hospitals (Bruce 2001; Gibbons 2011). In the UK it has been estimated that 4% to 5% of patients undergoing a surgical procedure contract an SSI (Health Protection Agency 2002; Smyth 2008), but this percentage varies greatly depending on the circumstances. Whilst various patient factors can predict the likelihood of SSI, the type of surgical procedure performed exerts a major influence on risk. Surgical procedures involving 'clean' body cavities have much lower numbers of infection, around 3% to 5%, compared with procedures involving body cavities with infected, necrotic or dirty tissue, for example, colorectal surgery, which have surgical infection figures of around 10% to 30% (McLaws 2000). A widely used definition that describes the contamination classification of surgical procedures is given below: Clean: non‐infective operative wounds in which no inflammation is encountered, and neither the respiratory, alimentary, genitourinary tract nor the oro‐pharyngeal cavity is entered. In addition these cases are elective, primarily closed, and drained with closed drainage system when required. Clean/contaminated: operative wounds in which the respiratory, alimentary, genital or urinary tract is entered under controlled conditions and without unusual contamination. Specifically, operations involving the biliary tract, appendix, vagina and oropharynx are included in this category, provided no evidence of infection or a major break in sterile technique is encountered. Contaminated: fresh, accidental wounds, operations with major breaks in sterile technique or gross spillage from the gastrointestinal tract, and incisions in which acute, non‐purulent inflammation is encountered. Dirty: old traumatic wounds with retained devitalised tissue and those that involve existing clinical infection or perforated viscera. This definition suggests that organisms causing postoperative infection were present in the operative field before the operation. SSIs not only cause considerable patient morbidity, but also increase the consumption of healthcare resources. In the UK, the mean additional cost of treating an infected surgical wound (compared with a non‐infected wound) was estimated at GBP 1618 (Plowman 2001), with much of this extra cost attributable to an increased length of hospital stay (mean increase of 6.5 days) (Plowman 2001). In the USA, de Lissovoy 2009 estimated that the extended length of stay and increased treatment costs associated with SSIs over a one‐year period led to approximately 1 million additional inpatient‐days, costing an additional USD 1.6 billion. Whilst SSIs can be difficult to define (one review identified 41 different definitions and 13 grading scales of SSI (Bruce 2001)), the Centers for Disease Control and Prevention (CDC) have published the following guidelines defining superficial and deep incisional SSIs (Horan 2008). A superficial SSI is defined as: an infection occurring within 30 days after the operation, that only involves the skin and subcutaneous tissue of the incision, and is associated with at least one of the following:
A deep incisional SSI is defined as: infection that occurs within 30 days after the operative procedure if no implant is left in place, or within one year if an implant is left in place, and the infection appears to be related to the operative procedure and involves deep soft tissues (e.g. fascial and muscle layers) of the incision associated with one of the following:
Dressings are widely used in the care of wounds. Several attributes of an ideal wound dressing have been described (BNF 2016; Goldman 1992; NICE 2008); these include:
Dressing products have evolved considerably in the last few decades, and now fall into broad, widely‐recognised categories, namely:
Within these groups there are many hundreds of dressing types available. For ease of comparison in this review, dressings have been classified into groups according to the British National Formulary (BNF) (BNF 2016). However, it is important to note that the distributors of dressings may vary from country to country, and that dressing names may also vary. Below we summarise key dressing groups as well as noting wound exposure where no dressing is used to cover a wound. Wound exposureIn some cases wounds may be left uncovered following surgery. They may have no dressing at all applied or a simple pad placed on the closed wound to absorb leakage which is removed shortly after. Basic wound contact dressingsAbsorbent dressings and surgical absorbentsAbsorbent dressings are applied directly to the wound. Surgical absorbents may be used as secondary absorbent layers in the management of heavily‐exuding wounds. Examples include Primapore® (Smith & Nephew), Mepore® (Mölnlycke), and absorbent cotton gauze, BP 1988. Low‐adherence dressings and wound contact materialsLow adherence dressings and wound contact materials are usually cotton pads that are placed directly in contact with the wound. They are either non‐medicated (e.g. paraffin gauze dressing), or medicated (e.g. containing povidone iodine or chlorhexidine). Examples include paraffin gauze dressing, BP 1993, Xeroform Dressing® ‐ a non‐adherent petrolatum blend with 3% bismuth tribromophenate on fine mesh gauze. Advanced dressingsVapour‐permeable filmsVapour‐permeable films are permeable to water vapour and oxygen, but not to water or micro‐organisms. They are normally transparent. Examples include OpSite® (Smith & Nephew) and Tegaderm® (3M). Hydrocolloid dressingsHydrocolloid dressings are occlusive dressings composed of a hydrocolloid matrix attached to a base (possibly film or foam). Fluid absorbed from the wound causes the hydrocolloid to liquefy. Examples include Comfeel® (Coloplast) and DuoDerm® (ConvaTec, UK). Fibrous hydrocolloid dressing (hydrofibre, spun hydrocolloid dressings)Fibrous hydrocolloid dressings are composed of sodium carboxymethylcellulose which forms a gel when it comes into contact with fluid. Examples include Aquacel® (ConvaTec, UK). Polyurethane matrix hydrocolloid dressingPolyurethane matrix hydrocolloid dressings consist of two layers ‐ a polyurethane gel matrix and a waterproof polyurethane top‐film designed to act as a bacterial barrier. There is only one dressing of this type listed in the BNF: Cutinova® Hydro (Smith & Nephew). Antimicrobial dressingsPolyhexametylene biguanide (PHMB) dressingPHMB dressings are impregnated with the antimicrobial agent polyhexanide. Topical skin adhesives (glue‐as‐dressing)Skin tissue adhesives are currently described in the BNF as being indicated for closure of minor skin wounds and for additional suture support. However, they can be used on an already closed wound as a dressing without an additional covering. They act as a barrier, are sterile before application and contain enbucrilate or octyl 2‐cyanoacrylate. Current practice for some surgical wounds healing by primary intention involves placement of a dressing over the closed wound before the patient leaves the clean environment of the operating theatre. This practice assumes that the risk of SSIs may be reduced by providing a barrier to environmental contamination. Furthermore, dressings may have additional roles in managing wound exudate, protecting wounds and their staples or sutures, and meeting patients' expectations by 'hiding' the wound, or, alternatively, when transparent dressings are used, facilitating health professionals' observation of the wound. Conversely, in other practices (e.g. paediatric surgery) it is usual not to use a dressing. This practice assumes that the risk of SSIs may be reduced by allowing the wound to dry. When wounds are covered by 'glue‐as‐a‐dressing' it is also assumed that this acts as a barrier that may reduce external infection. Surgical wounds healing by primary intention are commonplace within all elective and emergency surgical practice. It is important to assess whether wound dressings have a potential role in reducing the risk of SSI. Such information could inform allocation of resources to appropriate treatments. Currently these decisions are made with limited review data. In the UK, a government‐funded guideline reviewed the data from five trials that are relevant to this review, and concluded that existing studies did not show convincing differences in dressing effectiveness in terms of reducing SSI (NICE 2008). Whilst the review methods were robust, the search date was September 2007, and so studies published after this date were not assessed. Recent World Health Organisation guidelines have been published which assess one group of dressings, advanced dressings, compared with standard dressings (Allegranzi 2016). To assess the effects of wound dressings compared with no wound dressings, and the effects of alternative wound dressings, in preventing SSIs in surgical wounds healing by primary intention. Types of studiesRandomised controlled trials (RCTs) that compared the immediate postoperative application of wound dressings with no wound dressings, or compared alternative dressings, for surgical wounds expected to heal by primary intention. Types of participantsStudies involving adults or children (aged two years and over) who had undergone surgical procedures where healing of the surgical wound was planned by primary intention. Wounds of any contamination level (clean, clean/contaminated, contaminated and dirty) were eligible for inclusion. We excluded procedures involving graft sites, and wounds of the mouth and eye. Participants were required to have dressings applied in the operating theatre, immediately after closure of the skin. We excluded studies where participants had infected wounds at the start of the study. Types of interventionsThe primary intervention was wound exposure or application of wound dressings that could be:
We included comparisons of a dressing versus no dressing (exposed wound), and versus alternative dressings. We did not consider trials that compared different application durations of the same dressing (timing trials), as these will form a separate review. Nor did we include trials where the application of topical gels or ointments to wounds (in the absence of a dressing comparator) was evaluated, as we viewed these as different interventions. We did not include trials where the application of tissue adhesive was for the purpose of closing the wound only. The only difference between trial groups for included studies was the method of wound coverage used. Types of outcome measuresPrimary outcomesOccurence of postoperative SSI as defined by the CDC criteria (Horan 2008), or the authors' definition of SSI. We did not differentiate between superficial and deep‐incisional infection. Secondary outcomes
Electronic searchesIn September 2016 for our second update of this review we searched the following electronic databases:
The search string for CENTRAL can be found in Appendix 1. The search methods used for the original version of this review can be found in Appendix 2.The search strategies for Ovid MEDLINE, Ovid Embase and EBSCO CINAHL can be found in: Appendix 3; Appendix 4; and Appendix 5. The Ovid MEDLINE search was combined with the Cochrane Highly Sensitive Search Strategy for identifying randomised trials in MEDLINE: sensitivity‐ and precision‐maximising version (2008 revision) (Lefebvre 2011). We combined the Embase search with the Ovid EMBASE filter developed by the UK Cochrane Centre (Lefebvre 2011). We combined the CINAHL searches with the trial filters developed by the Scottish Intercollegiate Guidelines Network (SIGN 2015). There were no restrictions with respect to language, date of publication or study setting. Searching other resourcesWe searched the bibliographies of all retrieved and relevant publications identified by these strategies for further studies. While handsearches were not performed for this review, they are conducted by Cochrane Wounds in order to inform the CENTRAL database, which we searched. We did not contact manufacturers of dressings regarding studies for inclusion. We also searched the following clinical trials registries.
Selection of studiesTwo review authors independently assessed the studies' titles and abstracts against the review's inclusion criteria. After this initial assessment, we obtained all studies that might meet these criteria in full. Full papers were checked for eligibility by two review authors, with disagreements resolved by discussion and, where required, the input of a third review author. We extracted details of the eligible studies, and summarised them on a data extraction sheet. Two review authors extracted data independently. If data were missing from reports, we made attempts to contact the study authors to obtain the missing information. Studies that were published in duplicate we only included once, but extracted the maximum amount of data from the papers. Data extraction and managementAll data were extracted independently by two review authors. The following data were extracted:
Assessment of risk of bias in included studiesTwo review authors independently assessed each included study for risk of bias. Assessment was undertaken using the Cochrane `Risk of bias' tool (Higgins 2011). This tool considers six domains: sequence generation, allocation concealment, blinding, incomplete outcome data, freedom from selective reporting, and other issues (i.e. serious baseline imbalance). A `Risk of bias' table was completed for each eligible study; these data were combined into a `Risk of bias' summary figure where we have tabulated judgements for each domain by study. Measures of treatment effectWe presented results with 95% confidence intervals (CI). We reported estimates for dichotomous outcomes (e.g. infected: yes/no) as risk ratios (RR) (Deeks 2002). We reported continuous data (e.g. pain) as mean differences (MD), and we calculated overall effect sizes (with 95% CI). Unit of analysis issuesWhen we located three‐armed trials where only two of the arms were relevant to the review, we did not extract data for the non‐relevant arm. When three‐armed studies had two arms randomised to receive different brands of the same dressing, we combined these into one group and treated the trial as a two‐armed trial. We did not combine arms in three‐armed trials when all the arms received different, relevant interventions, in those cases we included all relevant comparisons. Dealing with missing dataWe did not consider the issue of missing data in the protocol for this review. The problem of missing data is common in trials, especially those of poor quality. Excluding participants from the analysis after randomisation, or ignoring participants lost to follow‐up can, in effect, undo the process of randomisation, and thus, potentially, introduce bias into the trial. For our primary outcome, SSI, we assumed that where randomised participants were not included in an analysis, they did not have an SSI (that is they were considered in the denominator but not the numerator). Given the relatively small number of SSI events anticipated, this seemed the most appropriate assumption. When a trial did not specify participant group numbers prior to drop out, we presented only complete case data. We present data for all secondary outcomes as complete case analysis. Assessment of heterogeneityOur assessment of heterogeneity comprised an initial assessment of clinical and methodological heterogeneity and the appropriateness of combining study results: that is the degree to which the included studies varied in terms of participant, intervention, outcome and characteristics such as length of follow‐up. We supplemented this assessment of clinical and methodological heterogeneity with information regarding statistical heterogeneity of the results ‐ assessed using the Chi² test (we considered that a significance level of P < 0.10 indicated statistically significant heterogeneity) in conjunction with the I² measure (Higgins 2003). I² examines the percentage of total variation across RCTs that is due to heterogeneity rather than chance (Higgins 2003). In general I² values of 25%, or less, may mean a low level of heterogeneity (Higgins 2003), and values of 75%, or more, indicate very high heterogeneity (Deeks 2011). We also examined the variability of the point estimates and the overlap of the confidence intervals, when I² values were less than 50%. Where there was evidence of high heterogeneity we explored this further: see Data synthesis. Assessment of reporting biasesReporting biases arise when the dissemination of research findings is influenced by the nature and direction of results. Publication bias, an across‐study reporting bias, is one of a number of possible causes of 'small study effects', that is, a tendency for estimates of the intervention effect to appear to be more beneficial in smaller RCTs. Funnel plots allow a visual assessment of whether small study effects may be present in a meta‐analysis. A funnel plot is a simple scatter plot of the effect estimates from individual RCTs against some measure of trial size or precision (Sterne 2011). If we had meta‐analyses that included 10 or more RCTs, we would have presented funnel plots using Cochrane Review Manager 5 software (RevMan 2014). However, we did not have sufficient studies for this. Data synthesisWe combined details of included studies in a narrative review according to dressing type and stratified by surgical contamination level. We explored both clinical and statistical heterogeneity. Where appropriate, we pooled data using meta‐analysis (conducted using RevMan 5), that is, where studies were considered similar in terms of intervention type, duration, and outcomes. We assessed statistical heterogeneity using the Chi² test (we considered that a significance level of P value less than 0.1 indicated heterogeneity), and the I² test (Higgins 2003). In the absence of clinical heterogeneity, and in the presence of statistical heterogeneity (I² over 50%), we used a random‐effects model. Where there was no clinical or statistical heterogeneity, we applied a fixed‐effect model. GRADE assessment and 'Summary of findings' tablesWe presented the main results of the review in 'Summary of findings’ tables for the following comparisons:
These tables present key information concerning the certainty of the evidence, the magnitude of the effects of the interventions examined, and the sum of available data for the main outcomes (Schünemann 2011a). The 'Summary of findings’ tables also include an overall grading of the evidence related to each of the main outcomes using the GRADE approach. This defines the certainty of a body of evidence as the extent to which one can be confident that an estimate of effect or association is close to the true quantity of specific interest. The certainty of a body of evidence involves consideration of within‐trial risk of bias (methodological quality), directness of evidence, heterogeneity, precision of effect estimates and risk of publication bias (Schünemann 2011b). We present the following outcomes in the 'Summary of findings’ tables:
For relevant outcomes reported for comparisons not listed above we have presented GRADE assessments without a 'Summary of findings' table. In terms of the GRADE assessment, when making decisions for the risk of bias domain we downgraded only when we had classed studies as being at high risk of bias for one or more domains and/or they were classed as being at unclear risk of bias for both domains that contribute to selection bias. In assessing the precision of effect estimates for SSI we followed GRADE guidance (GRADE 2013), and calculated an optimal information size (OIS) using conventional sample size calculation methods. We used the OIS, along with the size of 95% CIs ‐ in terms of whether they spanned estimates of benefit and harm ‐ to assess for downgrading. We calculated the OIS based on GRADE guidance of using a relative risk reduction of between 20% and 30%. The OIS is summarised below but should not be treated as optimal sample sizes for any future research. Within a GRADE assessment the OIS is used to assess the stability of CIs rather than to assess the appropriateness of a sample size to detect a difference. Our calculation was: reduction in SSI from 14% to 10% (80% power; alpha 5%) = 2070 participants. We also followed GRADE guidance and downgraded twice for imprecision when there were very few events and CIs around effects included both appreciable benefit and appreciate harm. See Characteristics of included studies; Characteristics of excluded studies;Characteristics of studies awaiting classification; Characteristics of ongoing studies for full details of studies identified. We are contacting the authors of three studies to clarify their eligibility for the review (Goharshenasan 2016; Siddiqui 2016; Springer 2015). We identified four relevant on‐going studies (ISRCTN06792113; {"type":"clinical-trial","attrs":{"text":"NCT02771015","term_id":"NCT02771015"}}NCT02771015; {"type":"clinical-trial","attrs":{"text":"NCT02904200","term_id":"NCT02904200"}}NCT02904200; {"type":"clinical-trial","attrs":{"text":"NCT02619773","term_id":"NCT02619773"}}NCT02619773). In searching trial registers we also located records for four studies marked as complete, which we could not link to published data on the basis of the information available (see Table 11). We have tried to contact representatives for these trials to locate possible unpublished data: this work is ongoing.
Included studiesA total of 29 RCTs met the inclusion criteria; nine being added in this 2016 update (Biffi 2012; Dickinson Jennings 2015; Kriegar 2011; Langlois 2015; Ozaki 2015; Politano 2011; Prather 2011; Ruiz‐Tovar 2015; Siah 2011). There are now 23 two‐arm trials and six three‐arm trials in the review. Ruiz‐Tovar 2015 was a three‐arm trial, but only two arms are relevant here and we did not extract data for the non‐relevant arm. In one three‐arm trial, two of the three arms were randomised to receive different brands of a film dressing (Cosker 2005). For this review, these two film‐dressing groups were combined into one group and the trial was treated as a two‐arm trial. Likewise, for Dickinson Jennings 2015 we combined two silver dressing arms. We did not combine arms for the remaining three‐arm trials, since all groups were deemed to have received different interventions, and so we included all relevant comparisons. In all trials the surgical procedure took place in a hospital operating theatre. In total 15 (52%) of the included trials have been published since 2007 (Bennett 2013; Biffi 2012; Burke 2012; Dickinson Jennings 2015; Kriegar 2011; Langlois 2015; Martin‐Trapero 2013; Ozaki 2015; Politano 2011; Prather 2011; Ravnskog 2011; Ruiz‐Tovar 2015; Shinohara 2008; Siah 2011; Vogt 2007). The trials took place in several different countries: 17 were conducted in Europe, four in the UK (Cosker 2005; Hewlett 1996; Law 1987; Moshakis 1984), two in Belgium (De Win 1998; Phan 1993); two in Sweden (Persson 1995; Wikblad 1995), two in Denmark (Holm 1998; Vogt 2007), one in Germany (Rohde 1979), one in Ireland (Burke 2012), two in Spain (Martin‐Trapero 2013; Ruiz‐Tovar 2015), one in France (Langlois 2015), one in Italy (Biffi 2012), and one in Norway (Ravnskog 2011). Two of the remaining trials were conducted in Australia (Lawrentschuk 2002; Wynne 2004), one in Pakistan (Gardezi 1983), seven in the USA (Bennett 2013; Dickinson Jennings 2015; Kriegar 2011; Michie 1994; Ozaki 2015; Politano 2011; Prather 2011), one in Japan (Shinohara 2008), and one in Singapore (Siah 2011). One trial was published in German (Rohde 1979), and one in Spanish (Martin‐Trapero 2013), and we acquired translations of these. The types of surgical procedures undertaken were varied and included cardiac and/or vascular surgery (Shinohara 2008; Vogt 2007; Wikblad 1995; Wynne 2004); caesarean sections (Bennett 2013), abdominal surgery and/or gastrointestinal surgery (Biffi 2012; Holm 1998; Kriegar 2011; Persson 1995; Martin‐Trapero 2013; Rohde 1979), or a number of different surgical procedures within the same trial (Burke 2012; Gardezi 1983; Hewlett 1996; Siah 2011). The surgical procedures in each trial were classified as having been clean, clean/contaminated, contaminated or dirty, or a combination of these (see Table 10 for classification). We recorded when the type of surgery performed was unclear (Rohde 1979). Studies also compared a range of different dressing types and regimens as described below and in Table 12.
Excluded studiesIn total, we excluded 99 studies after screening of the full text. There were a number of reasons for exclusions including 21 studies that were not RCTs and nine studies that included wounds healing by secondary intention, i.e. wounds that were left open, or had broken open, and were healing from deep to superficial layers. Full details are given in the Characteristics of excluded studies. For a summary PRISMA flow chart see Figure 1. See: Table 1; Table 2; Table 3; Table 4; Table 5; Table 6; Table 7; Table 8; Table 9
A summary of all extracted trial data can be found in Table 12 Wound dressings compared with exposed wounds (no dressing)Comparison 1: Basic wound contact dressings compared with exposed wound (no dressing) (2 trials; 319 participants)Two trials, involving a total of 319 participants, compared wound exposure with basic wound contact dressings. Law 1987 conducted a three‐arm trial where the surgical procedure had a 'clean' contamination classification (112 participants). The trial compared a basic wound contact dressing (removed after five days and changed if wound was discharging), with exposed wounds. Phan 1993 undertook a surgical procedure with clean and 'clean/contaminated' contamination classification and compared a basic wound contact dressing (changed twice daily) with exposed wounds that were treated with petroleum jelly (Vaseline). Primary outcome: SSIClean surgeryLaw 1987: it is uncertain whether there is a difference in SSI risk between basic wound contact‐dressed wounds (3/59; 5%) and exposed wounds (1/53; 2%) (RR for developing SSI in the exposed group compared with the basic wound contact = 0.37, 95% CI 0.04 to 3.46; Analysis 1.1;very low certainty evidence downgraded once for risk of bias and twice for imprecision,Table 1). Potentially contaminated surgery
Secondary outcomesClean surgery: scarringLaw 1987 reported that there was no difference in quality of final scar between the exposed group and the basic wound contact‐dressed group, but did not present data or was any information regarding who measured this outcome, how it was measured, or how long after surgery. The effect of these interventions on scarring is uncertain (very low certainty evidence downgraded once for risk of bias and twice for imprecision, Table 1). Clean surgery: acceptability The trial reported no difference in dressing preference as measured on a linear analogue scale, and presented no further information or data. The effect of these interventions on acceptability is uncertain (very low certainty evidence downgraded once for risk of bias and twice for imprecision, Table 1). Clean surgery: costsLaw 1987 reported that the mean total dressing costs per participant for the basic wound contact‐dressed group were GBP 6.60 compared with GBP 0.80 in the exposed group. No detailed information was presented i.e. the cost of complications, duration of stay in hospital and nurse time. The cost of dressing data alone is of limited value to decision makers. Potentially contaminated surgery
Summary: Basic wound contact dressings compared with exposed woundsIt is uncertain whether leaving surgical wounds exposed (no dressing) when healing by primary intention increases or decreases SSI risk compared with use of a basic wound contact dressing following clean surgery or surgery with the potential for contamination; we assessed the certainty of the evidence as very low (downgraded once for risk of bias and twice for imprecision,Table 1). The effect of these interventions on scarring and acceptability of dressings to patients is also uncertain as the certainty of evidence has been assessed as very low (downgraded once for risk of bias and twice for imprecision). The use of dressings incurs additional unit costs, but there are no cost‐effectiveness data available from these studies to facilitate informed decision making. Comparison 2: Film dressings compared with exposed wounds (1 trial; 107 participants)Law 1987 compared an exposed wound with a film‐dressed wound in 107 participants in clean surgery. Primary outcome: SSIClean surgeryLaw 1987: it is uncertain whether leaving surgical wounds exposed (1/53; 2%) leads to an increase or decrease in SSI risk compared with film‐dressed wounds (5/54; 9%) (RR 0.20, 95% CI 0.02 to 1.69; Analysis 2.1; very low certainty evidence, downgraded once for risk of bias and twice for imprecision,Table 2). Secondary outcomesClean surgery: scarringLaw 1987 reported that there was no difference in quality of final scar between the exposed group and the film group, but presented no data or any information regarding who measured this outcome, how it was measured, or how long after surgery. The effect of these interventions on scarring is uncertain (very low certainty evidence downgraded once for risk of bias and twice for imprecision, Table 2). Clean surgery: acceptability The trial reported no difference in dressing preference as measured on a linear analogue scale. No further information or data were presented. The effect of these interventions on acceptability is uncertain (very low certainty evidence downgraded once for risk of bias and twice for imprecision, Table 2). Clean surgery: costsLaw 1987: total mean dressing costs per participant for the film group were GBP 42.00 compared with GBP 0.80 in the exposed group. Summary: Film dressings compared with exposed woundIt is uncertain whether leaving surgical wounds to heal by primary intention exposed (no dressing) following clean surgery increases or reduces SSI risk compared with use of a film dressing; we assessed the certainty of the evidence as very low (downgraded once for risk of bias and twice for imprecision,Table 2). One trial reported that film dressings were more costly than leaving wounds exposed, but there are no cost‐effectiveness data available from the trial to facilitate informed decision making. Comparison 3: Silver dressings compared with exposed wounds (1 trial; 166 participants)Siah 2011 compared a silver dressing with wound exposure in 166 participants undergoing various types of elective colorectal surgery which were classed by review authors as clean/contaminated. Primary outcome: SSIPotentially contaminated surgery Siah 2011: it is unclear whether leaving a surgical wound exposed (8/83; 10%) leads to an increase or a decrease in SSI risk compared with a silver‐dressed wound (1/83; 1%). RR: 8.00, 95% 1.02 to 62.55 (Analysis 3.1; very low certainty evidence downgraded once for risk of bias and twice for imprecision,Table 3). Secondary outcomesSiah 2011 reported no relevant secondary outcomes. Summary: Silver dressings compared with exposed woundIt is uncertain whether leaving surgical wounds that are healing by primary intention exposed (no dressing) following surgery at risk of contamination increases or reduces SSI risk compared with use of a silver dressing; we assessed the certainty of the evidence as very low (downgraded once for risk of bias and twice for imprecision,Table 3). Dressings compared with other types of dressingsComparison 4: Comparisons between different basic wound contact dressings (1 trial; 50 participants)Lawrentschuk 2002 undertook a surgical procedure with a 'clean' contamination classification and compared a paraffin tulle dressing with a non‐adherent dressing in 50 participants (25 in each arm). Both dressing types were applied in the same way. In both groups a compressible, combined dressing was placed over the evaluated dressings with an adhesive elastic dressing then placed over these. Primary outcome: SSIClean surgeryLawrentschuk 2002: There was no clear difference in SSI risk between paraffin tulle‐dressing (0/25; 0%) compared with the non‐adherent dressings (3/25; 12%: RR 0.14, 95% CI 0.01 to 2.63; Analysis 4.1; low certainty evidence ‐ downgraded twice for imprecision); the 95% CI are wide and include both clinical benefit (in terms of reduced SSI risk) and harm (in terms of increased SSI risk). Summary: Basic wound contact dressings compared with different basic wound contact dressingsIt is not clear whether paraffin tulle dressings reduce the risk of SSI events in surgical wounds healing by primary intention following clean surgery compared with use of a non‐adherent dressing; the 95% CI are wide and include both clinical benefit (in terms of reduced SSI risk) and harm (in terms of increased SSI risk) (low certainty evidence; downgraded twice for imprecision). Comparison 5: Basic wound contact dressings compared with film dressings (8 trials; 1087 participants)Eight trials compared a basic wound contact dressing with a film dressing. Five of these trials evaluated wounds resulting from 'clean' surgical procedures (Cosker 2005; De Win 1998; Law 1987; Moshakis 1984; Wynne 2004), and three evaluated wounds resulting from surgical procedures with mixed, or unclear, contamination classifications (Gardezi 1983; Hewlett 1996; Rohde 1979). The trials included a variety of basic wound contact dressings including gauze and surgical absorbents. Similarly, whilst the comparators were all film dressings, different brands were evaluated (five trials evaluated Opsite (Smith & Nephew), three Tegaderm (3M Healthcare), and one an unnamed brand (Cosker 2005 evaluated two film dressings). Primary outcome: SSIClean surgeryUsing a fixed‐effect model we pooled data from the four trials with participants who had 'clean' surgery and that reported SSI data (Cosker 2005; De Win 1998; Law 1987; Wynne 2004) (Analysis 5.1). One further trial, Moshakis 1984 did not report SSI data. Whilst Law 1987 and Wynne 2004 were three‐arm trials, this was the only meta‐analysis conducted with their data, so the complete groups relevant to this pooling were used. De Win 1998 reported zero SSI events. There is uncertain evidence on the risk of SSI between basic wound contact‐dressed wounds and film‐dressed wounds (RR 1.34; 95% CI 0.70 to 2.55; Analysis 5.1; very low certainty evidence downgraded once for risk of bias and twice for imprecision,Table 4). Potentially contaminated surgeryGardezi 1983 conducted several surgical procedures that were classified as clean, clean/contaminated and possibly contaminated. There was no clear evidence of a difference in the risk of SSI in the basic wound contact‐dressed group (6/50; 12%) compared with the film‐dressed group (3/50; 6%) (RR 0.50 95% CI 0.13 to 1.89; Analysis 5.2; very low certainty evidence downgraded once for risk of bias and twice for imprecision;Table 4). Hewlett 1996: did not report SSI data. We could not be sure of the surgical classification of one further trial Rohde 1979. In total, 24/46 (52%) of participants in the basic wound contact dressing group had a mild wound infection compared with 14/44 (32%) in the film‐dressed group (RR 0.61; 95% CI 0.36 to 1.02 in favour of the film dressing. Given the difficulty in classifying the type of surgical procedure(s) undertaken in Rohde 1979, we did not pool this trial with Gardezi 1983. Overall it is unclear whether there is a difference in the risk of SSI in surgeries with different levels of potential contamination (very low certainty evidence downgraded once for risk of bias and twice for imprecision;Table 4). Secondary outcomesClean surgery: painMoshakis 1984: reported the levels of pain in each group. This was measured using a patient‐assessed linear scale (1 to 10) where 1 corresponded to 'no discomfort' and 10 to 'extremely uncomfortable or painful'. Mean pain levels in the basic wound contact group were 5.1 (SD 2.78) compared with 1.6 (SD 1.48) in the film‐dressed group, favouring film dressings: mean difference (MD ‐3.50; 95% CI ‐4.29 to ‐2.71; Analysis 5.3). We deemed this trial to be at high risk of bias for two domains and it did not take into account the cluster nature of data. Evidence is of very low certainty and all analyses in this trial must be interpreted with caution. Clean surgery: acceptabilityMoshakis 1984: participants and treating nurses were asked to rate their acceptability of the dressings, which were measured using a linear scale where 1 corresponded to 'no trouble' and 10 to 'very troublesome'. The mean response of basic wound contact‐dressed participants was 4.2 (SD 2.46) and the mean response of the film‐dressed group was 1.3 (SD 1.17; (MD ‐2.90; 95% CI ‐3.59 to ‐2.21, favouring the film‐dressed group; Analysis 5.4;very low certainty evidence downgraded twice for risk of bias and once for imprecision;Table 4). The mean acceptability response of the treating nurse was 5.4 (SD unknown) in the basic wound contact group and 1.2 (SD unknown) in the film group. Clean surgery: costsDe Win 1998: reported the total mean cost of dressings per participant in Belgian francs (now replaced by the Euro (EUR)): BEL 11.5 in the basic wound contact‐dressed group and BEL 14.3 in the film‐dressed group. No further economic data were presented in this trial. Law 1987 reported the mean per participant cost of the dressings in each group: GBP 6.60 in the basic wound contact group and GBP 42.00 in the film group. Potentially contaminated surgery: ease of removalRohde 1979: also reported figures for ease of dressing removal, but as there was no information about how these data were obtained or what they meant, we cannot interpret them (Table 12). Potentially contaminated surgery: painGardezi 1983: reported a measure for pain in each group, no details were provided regarding collection of these data or how they could be interpreted (Table 12). Potentially contaminated surgery: costsHewlett 1996: reported the mean per participant cost of dressings (including and excluding procedure pack) as GBP 1.60 for the basic wound contact‐dressed group compared with GBP 1.46 for the film‐dressed group or GBP 4.36 compared with GBP 2.84 when procedure packs were included. Rohde 1979 reported the cost per participant in Deutsch marks (now replaced by EUR) as DEM 10.40 in the basic wound contact‐dressed group and DEM 3.60 in the film group. Summary: Basic wound contact dressings compared with film dressingsIt is uncertain whether covering surgical wounds that are healing by primary intention with a film dressing increases or decreases the risk of SSI compared with use of a basic wound contact dressing following clean surgery or following surgery with other (or uncertain) contamination levels; we assessed the certainty of the evidence as very low (downgraded once for risk of bias and twice for imprecision,Table 4). It is uncertain whether people with wounds treated with film dressings reported better or worse acceptability compared with basic wound contact dressings (very low certainty evidence downgraded twice for risk of bias and once for imprecision;Table 4). The cost data presented were too limited to allow us to draw any conclusions based on costs versus benefits. Comparison 6: Basic contract wound dressings compared with hydrocolloid dressings (6 trials; 792 participants)Six trials investigated the effect of a basic wound contact dressing compared with a hydrocolloid dressing (Holm 1998; Michie 1994; Persson 1995; Shinohara 2008; Wikblad 1995; Wynne 2004). The basic wound contact dressings were predominantly gauze. Primary outcome: SSIClean surgeryMichie 1994: none of the 28 wound halves randomised to the basic wound contact dressing or the hydrocolloid dressing developed an SSI. Wikblad 1995 presented no clear SSI data. The authors reported that 11 participants were treated with antibiotics postoperatively, and eight of these participants had infections in the sternum (five of these participants were in the basic wound contact dressing group). No further information was provided. We classed this trial as being at a high risk of bias due to a large amount of missing data. Wynne 2004: it is uncertain whether there is a difference in SSI risk between hydrocolloid‐dressed (6/267; 2%) and basic wound contact‐dressed wounds (6/243; 3%) (RR 0.91; 95% CI 0.30 to 2.78; Analysis 6.1; very low certainty evidence downgraded once for risk of bias and twice for imprecision;Table 5). Potentially contaminated surgeryWe pooled data from all trials in this comparison that presented SSI data (Holm 1998; Persson 1995; Shinohara 2008). It is uncertain whether there is a difference in SSI risk between hydrocolloid‐dressed and basic wound contact‐dressed wounds: (RR 0.57; 95% CI 0.22 to 1.51; I² = 0%; Analysis 6.1; very low certainty evidence downgraded twice for risk of bias and twice for imprecision;Table 5). Secondary outcomesClean surgery: scarringMichie 1994: participants were asked to assess different aspects of scarring as either: excellent, good or fair. This was a split‐site trial with halves of the same wound randomised to different dressings. Four weeks postoperatively:
Data for these outcomes were also extracted at a seven‐month visit but are not presented here, as there were more missing data at this later time point. Further scarring assessments by investigators are reported in Table 12 Hydrocolloid dressings may lead to some improvement in cosmetic appearance of scars compared with basic wound contact dressings, but these data were low certainty evidence downgraded twice for imprecision (Table 5). Clean surgery: painWikblad 1995 reported pain at dressing removal; 76% of participants (raw data calculated by review author as 64/84) in the basic wound contact group reported no pain on removal, compared with 61% (calculated as 37/61) in the hydrocolloid group: RR 0.80; 95% CI 0.63 to 1.01 (Analysis 6.2). However, a large number of participants were missing from this trial, which we classed as being at high risk of bias. Clean surgery: acceptabilityWynne 2004: in the basic wound contact group 46/243 (19%) of participants reported that they were dissatisfied with the dressing compared with 75/267 (28%) in the hydrocolloid group (RR 1.48; 95% CI 1.07 to 2.05). It is not possible to tell how this dissatisfaction was influenced by the short time for which the basic wound contact dressing was in situ. It was unclear if participants were blinded to treatment. Hydrocolloid dressings may lead to more dressing dissatisfaction compared with basic wound contact dressings, but these data were low certainty evidence, downgraded once risk of bias and once for imprecision, Table 5). Clean surgery: ease of removalWikblad 1995 reported at five days postoperatively that 5/84 (6%) of respondents (clinicians) classified basic wound contact dressings as difficult to remove, compared with 13/61 (21%) in the hydrocolloid group (RR 3.58, 95% CI 1.35 to 9.51). Michie 1994 reported at three days postoperatively that 22/28 (79%) participants reported that the hydrocolloid dressing was easy to remove compared with 18/28 (64%) who reported that the basic wound contact dressing was easy to remove. This was a split‐site randomised trial. It is uncertain whether there are differences between hydrocolloid dressings and basic wound contact dressings in terms of ease of removal as the certainty of the evidence has been assessed as very low (downgraded twice for risk of bias, once for imprecision and once for inconsistency;Table 5). Clean surgery: costsWikblad 1995 reported the mean dressing cost per participant at USD 0.73 in the basic wound contact dressing group, and USD 3.60 in the hydrocolloid group. Wynne 2004 reported the median cost per participant of the basic wound contact dressing group as AUD 0.52, compared with AUD 3.93 for the hydrocolloid group. Again this value included only the cost of the dressings themselves, and not other important measures of resource‐use that should be considered when using cost as a decision tool, i.e. amount of nurse time, and cost of complications. Potentially contaminated surgery: scarring Shinohara 2008: The mean scar width for both groups was very similar; 2.3 mm (standard deviation 2.4 mm) in the basic wound contact group compared with 2.2 mm (standard deviation 2.4 mm) in the hydrocolloid group (mean difference ‐0.10, 95% CI ‐0.91 to 0.70). We judged the data to provide low certainty evidence, downgraded once for imprecision and once for indirectness (Table 5). Holm 1998 also reported the mean width of scars as 2.26 mm (range 1 mm to 5 mm) in the basic wound contact group and 1.78 mm (range 1 mm to 3 mm) in the hydrocolloid group (no standard deviation or related data presented) (Table 5). Potentially contaminated surgery: pain Persson 1995 reported participants' perceived pain associated with the wound, measured on a visual analogue scale (VAS) (0 to 100 mm) where a higher score indicted worse pain. The mean score for the basic wound contact group was 40 mm compared with 32 mm in the hydrocolloid group (no standard deviation data presented). We cannot interpret the data further. Potentially contaminated surgery: costsShinohara 2008: reported the mean cost of dressings per patient in the basic wound contact group (in Japanese Yen) as JPY 780, compared with JPY 715 in the hydrocolloid group. Summary: Basic wound contact dressings compared with hydrocolloid dressingsIt is uncertain whether covering surgical wounds healing by primary intention with a hydrocolloid dressing increases or decreases the risk of SSI compared with a basic wound contact dressing following clean surgery (very low certainty evidence, downgraded for once risk of bias and twice for imprecision) or following surgery with other contamination levels (very low certainty evidence downgraded twice for risk of bias and twice for imprecision) (Table 5). There was some low certainty evidence that hydrocolloid dressings may lead to some improvement in cosmetic appearance of scarring following clean surgery and other surgery types. Conversley there was low certainty evidence that hydrocolloid dressings may lead to more dissatisfaction with the dressing than basic wound contact dressings. It is uncertain whether there are differences between the dressings in terms of ease of dressing removal, as we assessed the certainty of the evidence as very low, (Table 5). Wikblad 1995 report that a basic wound contact dressing was less painful at removal than a hydrocolloid dressing, but the analysis had a large amount of missing data and we judged it to be at high risk of bias, as well as being imprecise: we assessed the evidence from this trial as being of very low certainty. Comparison 7: Basic wound contact dressings compared with fibrous‐hydrocolloid (hydrofibre) dressings (3 trials; 364 participants)Two trials compared a basic wound contact dressing with a hydrofibre dressing (Burke 2012; Vogt 2007). Vogt 2007 randomised 160 participants undergoing elective vascular surgery to either an absorbant dressing or a hydrofibre dressing, while Burke 2012 randomised 124 participants undergoing hip or knee replacement to either an absorbent or a Jubilee dressing. The Jubilee dressing was described as having a hydrofibre inner layer and hydrocolloid outer layer. We considered the hydrofibre layer to be the contact dressing. Langlois 2015 randomised 80 participants undergoing hip or knee replacement to receive a gauze dressing or a hydrofibre dressing. Primary outcome: SSIClean surgeryWe included all three studies in this analysis (Burke 2012; Langlois 2015; Vogt 2007). For Vogt 2007 we have used the results of an intention‐to‐treat analysis including withdrawals in the denominator only (did not have an SSI) as our methodology stipulated. We have also presented the raw data reported for reference purposes (Analysis 7.2). We pooled data from the studies: there was a total of 364 participants, but only one trial had outcome events (Vogt 2007), so the results are driven by this. It is uncertain whether covering surgical wounds that are healing by primary intention with a fibrous hydrocolloid dressing increases or decreases risk of SSI compared with a basic wound dressing following clean surgery, (RR 1.29; 95% CI 0.50 to 3.28; Analysis 7.1; very low certainty evidence downgraded once due to risk of bias and twice due to imprecision;Table 6). Secondary outcomesClean surgery: scarringLanglois 2015 measured patient satisfaction with appearance of scar in three ways. One was using a VAS for which it was not clear whether a low or high score was better. We have not reported this here. The trial also reported data on a categorical scale (poor, acceptable or excellent) and results of the Stoney Brook scale (see Table 12 for these data). Data are reported as medians with standard deviations (usually used to summarise mean data). Since data have not been presented using the mean or categories we have not analysed them further. Clean surgery: pain Langlois 2015 assessed by patients and nurses using a four‐point scale where 1 was `not satisfied'; 2 was `fairly satisfied'; 3 was `satisfied'; and 4 was `highly satisfied' ‐ see Table 12. The data were presented using medians and standard deviations, which means that further analyses within the review are not possible. Clean surgery: costsVogt 2007: while this trial reported the mean cost per participant (which included dressings, nurse time and other equipment, such as gloves), no further information was provided. The per participant cost of the basic wound contact group was reported in Euros as a range spanning EUR 10 to EUR 11.8 compared with EUR 20.3 to EUR 48.7 for the fibrous‐hydrocolloid group. Burke 2012 reported the mean number of dressing changes for each group, with more participants in the hydrofibre group requiring only one dressing change 61% (38/62), and fewer requiring two dressing changes (31%; 19/62), or three or more dressing changes (8%; 5/62) when compared with the absorbent dressing arm where 56% (35/63) of participants required two dressing changes and 31% (19/62) required three or more dressing changes. Summary: Basic wound contact dressings compared with fibrous‐hydrocolloid (hydrofibre) dressingsIt is uncertain whether covering surgical wounds that are healing by primary intention with a fibrous hydrocolloid dressing increases or decreases risk of SSI compared with a basic wound dressing following clean surgery; we assessed the certainty of the evidence as very low (downgraded once due to risk of bias and twice due to imprecision; Table 6). The cost of fibrous‐hydrocolloid dressings was higher than the cost of basic wound contact dressings, but they may require changing less often. Comparison 8: Basic wound contact dressings compared with polyurethane matrix hydrocolloid dressings (1 trial; 144 participants (estimated))Wikblad 1995 was a three‐arm trial, presented in comparison 6. It investigated the effect of a basic wound contact dressing compared with a polyurethane matrix hydrocolloid dressing after heart surgery. Primary outcome: SSIClean surgeryWikblad 1995 reported no interpretable data for SSI. The authors reported that 11 participants were treated with antibiotics postoperatively, and eight of these had infections in the sternum (of which five were in the basic wound contact dressing group). No further information was provided and the outcome was considered to be unreported (Table 7). Secondary outcomesClean surgery: ease of removalWikblad 1995: at five days postoperatively 5/84 (6%) of respondents (clinicians) reported that the basic wound contact dressings were difficult to remove, compared with 45/60 (75%) in the hydrocolloid group (RR 12.60, 95% CI 5.32 to 29.85 (no analysis presented); very low certainty evidence downgraded twice for risk of bias and once for imprecision; Table 7). Clean surgery: painWikblad 1995 reported pain at dressing removal and ease of removal; 76% of participants (calculated by review author as 64/84) in the basic wound contact dressing group reported no pain on removal, compared with only 14% (calculated by review authors as 8/60) in the hydrocolloid group. Fewer participants in the basic wound contact dressing group reported pain on dressing removal than in the matrix hydrocolloid group (RR 0.17; 95% CI 0.09 to 0.34; Analysis 8.1). A large number of participants were missing from this trial, which we classed as being at a high risk of bias. Clean surgery: costsWikblad 1995 reported the mean dressing cost per patient at USD 0.73 for the basic wound contact dressing group and USD 3.34 for the matrix hydrocolloid group. Summary: Basic wound contact dressings compared with polyurethane matrix hydrocolloid dressingsIt is uncertain whether covering surgical wounds that are healing by primary intention with a polyurethane matrix hydrocolloid dressing increases or decreases the risk of SSI compared with a basic wound contact dressing following clean surgery; we assessed the certainty of the evidence as very low. The only trial to contribute data was poorly reported and at high risk of attrition bias with no SSI outcome data that could be used (Table 7). It was uncertain whether the basic wound contact dressing was easier to remove than the hydrocolloid dressing (very low certainty evidence;Table 7). The unit cost of the hydrocolloid dressing was higher than that of the basic wound contact dressing. Comparison 9: Basic wound contact dressings compared with silver dressings (8 trials; 1959 participants)Eight studies were considered in this comparison. Two studies included participants undergoing clean surgery (Dickinson Jennings 2015; Politano 2011). Politano 2011 randomised 145 participants to either a basic wound contact dressing or a silver‐containing dressing. Twenty‐five SSIs were reported in the silver dressing group compared with 19 in the standard dressing group. It was not clear from the report whether these events occurred in separate people, but we have assumed this in our treatment of the data here. Dickinson Jennings 2015 was a three‐arm trial that compared a basic wound dressing to two types of silver dressing. For the purpose of the review, we pooled the silver dressing arms. Six studies compared the use of a basic wound dressing with a silver‐containing dressing in surgery at risk of contamination. Four studies involved colorectal surgery (Biffi 2012; Kriegar 2011; Prather 2011; Ruiz‐Tovar 2015). Bennett 2013 randomised 524 participants who had undergone a caesarean section; these can be clean, clean/contaminated, contaminated or dirty depending on timing of membrane rupture and other operative conditions ‐ data on the contamination level of the operations was not presented and so we classed it as mixed although it is likely that most operations were clean. Ozaki 2015 randomised 500 people undergoing a non‐emergency surgical procedure for peripheral vascular disease. Primary outcome: SSIClean surgeryWe pooled SSI data from the two clean surgery studies using a random‐effects model (I² = 34%; Chi² P value = 0.22). Based on the average effect, it is uncertain whether silver dressings increase or reduce the risk of SSI compared with a basic wound dressing (RR 1.11; 0.47 to 2.62; Analysis 9.1; very low certainty evidence downgraded once for risk of bias and twice for imprecision; Table 8). Potentially contaminated surgeryWe pooled SSI data from the studies where surgery was at risk of contamination using a random‐effects model ( I² = 40%; Chi² P value = 0.15) (Bennett 2013; Biffi 2012; Kriegar 2011; Ozaki 2015; Ruiz‐Tovar 2015). Based on the average effect of silver dressings it is uncertain whether use of silver dressings reduces the risk of SSI after potentially contaminated surgery compared with the basic wound contact dressings (RR 0.83; 95% CI 0.51 to 1.37; Analysis 9.1; very low certainty evidence downgraded twice for risk of bias and twice for imprecision;Table 8). Secondary outcomesClean surgery: painDickinson Jennings 2015 reported pain data for the three trial arms, but no variation data were reported and we have not considered these data further (see Table 12). Clean surgery: ease of removal Dickinson Jennings 2015 reported ease of removal data for the two types of silver dressings, but the data were not clear for the comparator group and so are not considered further (see Table 12). Potentially contaminated surgery: painPrather 2011 measured pain using a 0 to 10 scale with 0 being 'no pain' and 10 being 'worst pain'. At baseline the mean pain score in the silver dressing group was 5 and in the gauze group was 5. Subsequent data were presented for each day until day seven when the mean pain score was 4 in the control group and 2 in the silver group. No standard deviation data were presented and no further analysis is presented here. Potentially contaminated surgery: costsBennett 2013 presented the total dressing costs per group. The group total for the basic wound contact group was USD 307 and the total for the silver group was USD 11,080. No standard deviation data were presented and data are not analysed further. Summary: Basic wound contact dressings compared with silver‐containing dressingsIt is uncertain whether covering surgical wounds that are healing by primary intention with a silver‐containing dressing increases or decreases the risk of SSI compared with a basic wound contact dressing following clean surgery (very low certainty evidence downgraded once for risk of bias and twice for imprecision) or following potentially contaminated surgery (very low certainty evidence downgraded twice for risk of bias and twice for imprecision;Table 8). Data for secondary outcomes were very limited. Comparison 10: Basic wound contact dressing compared with non‐silver antimicrobial dressings (1 trial; 197 participants)Martin‐Trapero 2013 randomised participants undergoing elective laparoscopic cholecystectomy to a basic wound contact or PHMB antimicrobial dressing. Primary outcome: SSIClean surgeryIt is not clear whether there is a difference in SSI risk between the basic wound contact dressing group (5/101; 5%) and the PHMB dressing‐treated group (1/96; 1%), as the 95% CIs are wide and include benefits (in terms of reduced SSI risk) and harms (in terms of increased SSI risks) (RR 0.21, 95% CI 0.03 to 1.77; Analysis 10.1; low certainty evidence downgraded twice due to imprecision; Table 9). Secondary outcomesThis trial provided no data for our secondary outcomes.. Summary: Basic wound contact dressings compared with non‐silver antimicrobial dressingsIt is not clear whether PHMB dressings reduce SSI risk in surgical wounds healing by primary intention compared with a basic wound contact dressing following clean surgery; the 95% CIs are wide and include benefits (in terms of reduced SSI risk) and harms (in terms of increased SSI risks) (low certainty evidence downgraded twice due to imprecision; Table 9). Comparison 11: Comparisons between advanced dressings (3 trials; 694 participants)We considered three studies in this comparison (Ravnskog 2011; Wikblad 1995; Wynne 2004). We included two arms of Wynne 2004 (a three‐arm trial): one arm received a film dressing (left in situ for five days) and another a hydrocolloid dressing (also left in situ for five days). Ravnskog 2011 compared an alginate dressing with a hydrofibre dressing in 200 participants undergoing hip replacement. The trial reported only pain data that could be included in this review. Primary outcome: SSIClean surgeryWikblad 1995 presented no clear data for SSIs. In Wynne 2004 it was uncertain whether use of a film‐dressing reduces risk of SSI (9/227; 4%) compared with a hydrocolloid‐dressing (6/267; 2%) (RR 0.57; 95% CI 0.20 to 1.57; Analysis 11.1; very low certainty evidence downgraded once due to risk of bias and twice due to imprecision). Secondary outcomesClean surgery: acceptability Wynne 2004: in the hydrocolloid group 75/267 (28%) of participants reported that they were dissatisfied with the hydrocolloid dressing compared with 80/227 (35%) in the film group (RR 0.80; 95% CI 0.61 to 1.03) (no analysis presented). It was unclear if participants were blinded to treatment. Clean surgery: ease of removal In Wikblad 1995 13/61 (21%) respondents (clinicians) in the hydrocolloid group reported that the dressing was not difficult to remove compared with 45/60 (75%) in the matrix hydrocolloid group (RR 3.52, 95% CI 2.13 to 5.82) (no analysis presented). However, a large number of participants were missing from this trial, which was classed as being at high risk of bias and data were imprecise and uncertain (very low certainty evidence). Clean surgery: pain Ravnskog 2011 used a VAS scale to measure: pain from the dressing during mobilisation; Itching under the dressing; burning pain under the dressing; discomfort caused by use of the dressing; and pain score at dressing removal. The data from the VAS scale were not clear, so these were not analysed further. Participants were also asked whether they had pain at removal of the dressing. In total 2.1% in the alginate dressing group had experienced pain compared with 15% in the hydrofibre dressing group (numerator and denominator data were not presented in the trial report). In Wikblad 1995, 14% of participants (calculated by review authors as 8/60) in the hydrocolloid group reported no pain at dressing removal compared with 61% (calculated as 37/61) in the matrix‐hydrocolloid group. However, a large number of participants was missing from this trial, which we classed as being at high risk of bias, and the data are imprecise. The effect of these interventions on pain is uncertain (very low certainty evidence). Clean surgery: costsWikblad 1995 reported the mean dressing cost per participant at USD 3.60 for the hydrocolloid dressing group and USD 3.34 for the matrix hydrocolloid group. Wynne 2004 reported the median cost of the hydrocolloid dressing group in Australian dollars as AUD 3.93, compared with AUD 1.59 for a film dressing. Again this value included only the cost of the dressings themselves, and not other important measures of resource use that should be considered when using cost as a decision tool, i.e. amount of nurse time, and cost of complications. Summary: Advanced dressings compared with another advanced dressingIt is uncertain whether covering surgical wounds that are healing by primary intention with a hydrocolloid dressing increases or decreases the risk of SSI compared with a film dressing following clean surgery, as we have assessed the certainty of evidence as very low (downgraded once due to risk of bias and twice due to imprecision). The limited data means that there is uncertainty about whether any one advanced dressing confers better acceptability or usage. The primary aim of this systematic review was to present and appraise all existing evidence regarding the relative effectiveness of various surgical dressings, including not using a dressing, and using glue as a dressing, on the risk of developing surgical site infections (SSIs) in surgical wounds that are healing by primary intention. We found insufficient evidence that covering surgical wounds with any dressing compared with leaving them exposed influences the subsequent risk of SSI. Similarly there was insufficient evidence on which to base solid conclusions regarding whether any single type of dressing reduces risk of SSIs in wounds resulting from surgery. GRADE assessments of the evidence resulted predominantly in judgements of very low certainty. The studies included in the analyses were small and had low numbers of events. This means that the available evidence had low statistical power and that for most comparisons we could not exclude the possibility that there might be differences in effectiveness; currently, there is not enough information of a high enough certainty to be sure. Some studies were at a high risk of bias and were lacking important details in reports about trial populations or how outcomes were defined and when outcome data were collected. We included a range of contamination levels for the many trials that investigated 'non clean' surgery, and it was not possible to draw conclusions for each. For secondary outcomes, there is again uncertainty due to the certainty of the evidence being low or very low. The results of Moshakis 1984 suggested that film dressings might be less painful for patients than other basic wound contact dressings. However, we judged this trial to be at high risk of bias due to inadequate allocation concealment, and the absence of evidence that appropriate statistical procedures had been employed to accommodate the inclusion of some participants as their own controls (bilateral excisions). Wikblad 1995 reported that basic wound contact dressings were significantly less painful on removal than hydrocolloid dressings. However, a large amount of data were missing from this analysis, and we deemed it, too, to be at a high risk of bias. A number of trials suggested that advanced dressings were more expensive than basic wound contact dressings. However, all cost evaluations were very limited, and did not capture all relevant resource‐use data, or consider the costs versus the benefits of treatments ‐ which is best practice in economic evaluation. In short the economic data included in these studies did not lend themselves to decision making. There are many different dressing options to use postoperatively on surgical wounds. We identified 29 studies to include in this review, these assessed several dressing types, as well as leaving wounds exposed. There are no studies that evaluated glue‐as‐dressing. The included studies reported limited outcome data, even for the primary outcome of SSI. Where SSI was reported, the process used to define infection was often not reported, nor was it clear over what follow‐up period data collection took place. Outcomes for other important patient outcomes such as scarring were also poorly reported, with a range of measures used for assessment, which were sometimes unclear. Frequently, studies were very small in terms of number of participants and outcome events, which meant most included studies were very underpowered. Paradoxically the small, underpowered nature of studies means, that as well as being at risk of type 2 errors (that is missing important differences), they are at increased risk of type I errors as statistically significant findings are more likely to be spurious (Button 2010). Overall, the limited methodological reporting, the small sample sizes and the limited quality of outcome data collection, results in an insufficient volume of potentially biased evidence, which may be selectively reported. In general, the quality of the studies was very low and difficult to assess due to the lack of methodological detail reported. The majority of the included studies were more than 10 years old and did not follow current trial conduct and reporting guidelines, i.e. CONSORT (Schulz 2010). Key areas of good practice include the robust generation of a randomisation sequence (e.g. by a computer‐generated randomisation schedule); robust allocation concealment (e.g. through the use of a telephone randomisation service); and blinded outcome assessment where this is possible. Blinded outcome assessment is also crucial for assessment of outcomes such as SSI where there may be a subjective element in decision making, as non‐blinded assessment can introduce detection/observer bias (Hróbjartsson 2012), however, blinded assessment was not implemented in six studies, and not clearly reported in 20 more. Key methodological information should be included in the trial report. In terms of analysis, data from all participants should be included in the analysis whenever possible, i.e. an intention‐to‐treat analysis should be conducted. Steps should be taken during a trial to minimise missing data as far as possible. Where missing data were an issue, imputation methods should be considered and clearly reported when implemented. When studies plan to evaluate more than one wound per person, or use participants as their own controls, or both, they should consult a statistician regarding both the trial design, sample size issues and the more advanced type of analysis that is required and, where possible, robust economic data should be collected. A number of trials included multiple surgical procedures with different levels of potential contamination; since they did not report data for each type separately, this limited the value of the data for analysis. We conducted a comprehensive search that included trial registries, and obtained translations as required, so we do not believe that language bias is an issue. We were not able to explore publication bias using the studies we had, so the potential for bias for that is unknown. We did not deviate from the prepublished protocol, so do not believe bias has been introduced in terms of selective outcome reporting on our part. It is noteworthy that we found four studies reported on a trial register (one of these trials was reported on two registers) which we are unable to link to published data. We contacted trial contacts to try to obtain any data we did not have. Where unpublished data exist and are not included in a review, there is an increase in the risk of publication bias. We are not aware of any other published systematic reviews of dressings for surgical wounds that are healing by primary intention. Another review, however, regarding the use of wound dressings on surgical wounds was conducted as part of the development of a set of UK clinical guidelines addressing the prevention and treatment of SSIs (NICE 2008). This review generally reached similar conclusions to this systematic review. We would like to note, however, that the conclusions of this Cochrane Review are based on additional trials that were not included in the NICE review. Our review does differ from the NICE review with regard to our use of healing data from Wikblad 1995. We did not utilise the limited infection data that were provided solely in the text of this three‐arm trial (which reported that 11 participants were treated with antibiotics postoperatively; eight had infections in the sternum: five were from the basic wound contact dressing group, but group(s) for the remaining three participants were not specified). The NICE review merged two of the three trial arms (a hydrocolloid‐dressed arm and a film‐dressed arm), and, as we cannot replicate their analysis, its authors may have obtained additional data (they reported six SSIs in the basic wound contact group and two in the merged hydrocolloid/film group). With regard to this trial, the NICE review concluded that: "there is limited evidence to suggest that there is a difference favouring the use of hydrocolloids or 'hydroactive' (film) dressings against the use of absorbent dressings in the prevention of SSI". Our review does not agree with this finding; however, the overall conclusions of the NICE review regarding wound dressings were limited to: "Cover surgical incisions with an appropriate interactive dressing at the end of the operation". The NICE report also conducted its own costing exercise, given that there were no data from the studies that could be used. They concluded that it is important to take into account the additional costs of changing dressings, as well as the initial price of each dressing type, when choosing dressings to use (NICE 2008). The recent World Health Organisation guideline is supported by a systematic review containing 19 trials ‐ all included here. The review had a narrower remit comparing advanced dressings with standard dressings. The review reports advanced dressings as: Hydrocolloid; Silver‐impregnated Hydroactive and PHMB. The review also reports very low quality evidence for each of these comparisons (Allegranzi 2016). The guideline recommendation, suggests not using advanced dressings in preference to standard dressings on primarily closed surgical wounds for the purpose of preventing SSI and rates the evidence as low quality. Implications for practiceThere is currently insufficient evidence to determine whether covering surgical wounds that are healing by primary intention with wound dressings reduces the risk of surgical site infections (SSIs), or whether any particular type of wound dressing reduces the risk of infections more than another. Our review also failed to demonstrate any clear advantage of one dressing type over another (or wound exposure) for improved scarring, pain control, patient acceptability or ease of removal. It is important to note that many trials in this review were small and of poor quality, and at high or unclear risk of bias. Given the current evidence, decision makers may wish to make wound dressing choices on costs and clinician and patient preference. Additional steps to prevent SSIs can be based on other existing evidence and guidelines, for example the use of hand decontamination and antibiotic prophylaxis (NICE 2008). Implications for researchThere is a lack of high quality research evidence regarding whether choice of wound dressing (or indeed use of wound dressings at all) affects the risk of SSIs in people whose surgical wounds are healing by primary intention. Whilst uncertainty remains regarding the best approach to dressing these surgical wounds, any investment in future research must maximise its value to decision‐makers. Given both the large number of dressing options and surgical procedures, the design of future trials should focus on those surgical procedures at highest risk of SSI, as well as evaluating the dressings or approaches that health professionals use most widely. In addition, as SSIs can be relatively rare events, very large trials are needed in terms of participant numbers. Such epidemiological information is vital to inform dressing trials and will become available through robust, routine data collection. Additionally, there may be value in asking decision‐makers (including patients) what they feel are the most pressing issues, e.g. type of dressing, or duration that a dressing remains in situ, as well as which outcomes are most important, including the ability of different dressings to manage specific symptoms such as absorption of exudate. Such planning means that research resources can be focused to address priorities. Where trials are conducted, good practice guidelines must be followed in their design, implementation and reporting.
Protocol first published: Issue 1, 2000
The authors would like to acknowledge the contribution of peer referees at both the protocol, review and update stage: Andrea Nelson, Joan Webster, Gill Worthy, Laura Bolton, John McCall, Sonya Osborne, Mark Rogers and Jane Nadel. We would also like to thank Elizabeth Royle for copy editing the review and the updated reviews. #1 MeSH descriptor: [Bandages] explode all trees #2 MeSH descriptor: [Hydrogels] explode all trees #3 MeSH descriptor: [Alginates] explode all trees #4 (dressing* or hydrocolloid* or alginate* or hydrogel* or foam or bead or film or films or tulle or gauze or non‐adherent or non adherent):ti,ab,kw (Word variations have been searched) #5 MeSH descriptor: [Tissue Adhesives] explode all trees #6 MeSH descriptor: [Fibrin Tissue Adhesive] explode all trees #7 tissue next adhesive*:ti,ab,kw (Word variations have been searched) #8 MeSH descriptor: [Cyanoacrylates] explode all trees #9 octylcyanoacrylate*:ti,ab,kw (Word variations have been searched) #10 Dermabond:ti,ab,kw (Word variations have been searched) #11 MeSH descriptor: [Enbucrilate] explode all trees #12 Enbucrilate:ti,ab,kw (Word variations have been searched) #13 butylcyanoacrylate*:ti,ab,kw (Word variations have been searched) #14 MeSH descriptor: [Acrylates] explode all trees #15 acrylate*:ti,ab,kw (Word variations have been searched) #16 MeSH descriptor: [Bucrylate] explode all trees #17 bucrylate*:ti,ab,kw (Word variations have been searched) #18 {or #1‐#17} #19 MeSH descriptor: [Surgical Wound Infection] explode all trees #20 MeSH descriptor: [Surgical Wound Dehiscence] explode all trees #21 (surg* near/5 infect*):ti,ab,kw #22 (surg* near/5 wound*):ti,ab,kw #23 (wound* near/5 infection*):ti,ab,kw #24 (surg* near/5 incision*):ti,ab,kw #25 (surg* near/5 site*):ti,ab,kw #26 {or #19‐#24} #27 {and #18, #26} in Trials For the original review, we searched the following electronic databases:
The search used is listed below #1 MeSH descriptor Bandages explode all trees#2 (dressing* or hydrocolloid* or gauze* or hydrogel* or alginate* or "bead" or "foam"):ti,ab,kw #3 (#1 OR #2) #4 MeSH descriptor Surgical Wound Infection explode all trees #5 MeSH descriptor Surgical Wound Dehiscence explode all trees #6 (surg* NEAR/5 infect*):ti,ab,kw #7 (surg* NEAR/5 wound*):ti,ab,kw #8 (wound* near/5 infection*):ti,ab,kw #9 (surg* NEAR/5 incision*):ti,ab,kw #10 (surg* NEAR/5 site*):ti,ab,kw #11 (#4 OR #5 OR #6 OR #7 OR #8 OR #9) #12 (#3 AND #11) The Ovid MEDLINE search was combined with the Cochrane Highly Sensitive Search Strategy for identifying randomised trials in MEDLINE: sensitivity‐ and precision‐maximizing version (2008 revision) (Lefebvre 2009). The Ovid EMBASE and EBSCO CINAHL searches were combined with the trial filters developed by the Scottish Intercollegiate Guidelines Network (SIGN) (SIGN 2010). There were no restrictions on the basis of date or language of publication. 1. exp Bandages/ 2. exp Hydrogels/ 3. exp Alginates/ 4. (dressing* or hydrocolloid* or alginate* or hydrogel* or foam or bead or film or films or tulle or gauze or non‐adherent or non adherent).ti,ab. 5. exp Tissue Adhesives/ 6. exp Fibrin Tissue Adhesive/ 7. tissue adhesive$.mp. 8. exp Cyanoacrylates/ 9. octylcyanoacrylate$.mp. 10. Dermabond.mp. 11. exp Enbucrilate/ 12. Enbucrilate$.mp. 13. butylcyanoacrylate$.mp. 14. exp Acrylates/ 15. acrylate$.mp. 16. exp Bucrylate/ 17. bucrylate$.mp. 18. or/1‐17 19. exp Surgical Wound Infection/ 20. exp Surgical Wound Dehiscence/ 21. (surg* adj5 infection*).ti,ab. 22. (surg* adj5 wound*).ti,ab. 23. (wound* adj5 infection*).ti,ab. 24. surgical site*.mp. 25. or/19‐24 26. randomised controlled trial.pt. 27. controlled clinical trial.pt. 28. randomi?ed.ab. 29. placebo.ab. 30. clinical trials as topic.sh. 31. randomly.ab. 32. trial.ti. 33. or/26‐32 34. exp animals/ not humans.sh. 35. 33 not 34 36. and/18,25,35 1. exp Wound Dressing/ 2. exp Hydrogel/ 3. exp Alginic Acid/ 4. (dressing* or hydrocolloid* or alginate* or hydrogel* or foam or bead or film or films or tulle or gauze or non‐adherent or non adherent).ti,ab. 5. exp Tissue Adhesive/ 6. exp Fibrin Glue/ 7. (tissue adj adhesive$).mp. 8. exp Cyanoacrylate Derivative/ 9. exp Cyanoacrylic Acid Octyl Ester/ 10. octylcyanoacrylate$.mp. 11. Dermabond.mp. 12. exp ENBUCRILATE/ 13. enbucrilate.mp. 14. butylcyanoacrylate$.mp. 15. exp Acrylic Acid/ 16. acrylate$.mp. 17. exp Bucrilate/ 18. bucrylate$.mp. 19. or/1‐18 20. exp Surgical Wound Infection/ 21. exp Wound Dehiscence/ 22. (surg* adj5 infection*).ti,ab. 23. (surg* adj5 wound*).ti,ab. 24. (wound* adj5 infection*).ti,ab. 25. surgical site*.ti,ab. 26. or/20‐25 27. Randomized controlled trials/ 28. Single‐Blind Method/ 29. Double‐Blind Method/ 30. Crossover Procedure/ 31. (random$ or factorial$ or crossover$ or cross over$ or cross‐over$ or placebo$ or assign$ or allocat$ or volunteer$).ti,ab. 32. (doubl$ adj blind$).ti,ab. 33. (singl$ adj blind$).ti,ab. 34. or/27‐33 35. exp animals/ or exp invertebrate/ or animal experiment/ or animal model/ or animal tissue/ or animal cell/ or nonhuman/ 36. human/ or human cell/ 37. and/35‐36 38. 35 not 37 S34 S13 AND S21 AND S33 S33 S22 or S23 or S24 or S25 or S26 or S27 or S28 or S29 or S30 or S31 or S32 S32 TX allocat* random* S31 (MH "Quantitative Studies") S30 (MH "Placebos") S29 TX placebo* S28 TX random* allocat* S27 (MH "Random Assignment") S26 TX randomi* control* trial* S25 TX ( (singl* n1 blind*) or (singl* n1 mask*) ) or TX ( (doubl* n1 blind*) or (doubl* n1 mask*) ) or TX ( (tripl* n1 blind*) or (tripl* n1 mask*) ) or TX ( (trebl* n1 blind*) or (trebl* n1 mask*) ) S24 TX clinic* n1 trial* S23 PT Clinical trial S22 (MH "Clinical Trials+") S21 S14 or S15 or S16 or S17 or S18 or S19 or S20 S20 TI (postoperative* N5 infection* OR post‐operative* N5 infection*) or AB (postoperative* N5 infection* OR post‐operative* N5 infection*) S19 TI wound* N5 infection* or AB wound* N5 infection* S18 TI surg* N5 wound* or AB surg* N5 wound* S17 TI surg* N5 infection* or AB surg* N5 infection* S16 (MH "Surgical Wound") S15 (MH "Surgical Wound Dehiscence") S14 (MH "Surgical Wound Infection") S13 S1 OR S2 OR S3 OR S4 OR S5 OR S6 OR S7 OR S8 OR S9 OR S10 OR S11 OR S12 S12 TI Dermabond or AB Dermabond S11 TI enbucrilate or AB enbucrilate S10 TI bucrylate* or AB bucrylate* S9 TI acrylate* or AB acrylate* S8 TI butylcyanoacrylate* or AB butylcyanoacrylate* S7 TI octylcyanoacrylate* or AB octylcyanoacrylate* S6 TI cyanoacrylate* or AB cyanoacrylate* S5 TI tissue adhesive* or AB tissue adhesive* S4 (MH "Fibrin Tissue Adhesive") S3 TI ( dressing* or pad or pads or gauze or tulle or film or bead or foam* or non‐adherent or non adherent or hydrocolloid* or alginat* or hydrogel* ) or AB ( dressing* or pad or pads or gauze or tulle or film or bead or foam* or non‐adherent or non adherent or hydrocolloid* or alginat* or hydrogel* ) S2 (MH "Alginates") S1 (MH "Bandages and Dressings+") Low risk of biasThe investigators describe a random component in the sequence generation process such as: referring to a random number table; using a computer random number generator; coin tossing; shuffling cards or envelopes; throwing dice; drawing of lots. High risk of biasThe investigators describe a non‐random component in the sequence generation process. Usually, the description would involve some systematic, non‐random approach, for example: sequence generated by odd or even date of birth; sequence generated by some rule based on date (or day) of admission; sequence generated by some rule based on hospital or clinic record number. UnclearInsufficient information about the sequence generation process provided to permit a judgement of low or high risk of bias. Low risk of biasParticipants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: central allocation (including telephone, web‐based and pharmacy‐controlled randomisation); sequentially‐numbered drug containers of identical appearance; sequentially‐numbered, opaque, sealed envelopes. High risk of biasParticipants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation based on: use of an open random allocation schedule (e.g. a list of random numbers); assignment envelopes without appropriate safeguards (e.g. envelopes were unsealed, non‐opaque, or not sequentially numbered); alternation or rotation; date of birth; case record number; any other explicitly unconcealed procedure. UnclearInsufficient information provided to permit a judgement of low or high risk of bias. This is usually the case if the method of concealment is not described, or not described in sufficient detail to allow a definite judgement, for example if the use of assignment envelopes is described, but it remains unclear whether envelopes were sequentially numbered, opaque and sealed. Low risk of biasAny one of the following:
High risk of biasAny one of the following:
UnclearEither of the following:
Low risk of biasAny one of the following:
High risk of biasAny one of the following:
UnclearEither of the following:
Low risk of biasEither of the following:
High risk of biasAny one of the following:
UnclearInsufficient information provided to permit a judgement of low or high risk of bias. It is likely that the majority of studies will fall into this category. Low risk of biasThe study appears to be free of other sources of bias. High risk of biasThere is at least one important risk of bias. For example, the study:
UnclearThere may be a risk of bias, but there is either:
New search for studies and content updated (no change to conclusions)
As a result of feedback from the peer referees the title of this review has been changed from: Wound dressings for surgical sites; to: Dressings for the prevention of surgical site infection. Jo Dumville co‐ordinated the review, extracted data and checked the quality of data extraction, undertook and checked quality assessment, analysed and interpreted data, performed and checked the quality of the statistical analysis, completed the first draft of the review, performed part of the writing or editing, made an intellectual contribution to the review, approved the final version prior to submission, wrote to trial authors/experts/companies and is guarantor for the review and the review update. Trish Gray contributed to the previous update of this review, checked the quality of data extraction, undertook and checked quality assessment, and checked quality of statistical analysis, performed part of the writing or editing, made an intellectual contribution to the review update, and approved the final version of the review update prior to submission. Catherine Walter performed previous work that was the foundation of the current review. Catherine Sharp performed previous work that was the foundation of the current review. Tamara Page performed previous work that was the foundation of the current review. Rhiannon Macefield contributed to the update of this review, checked the quality of data extraction, undertook and checked quality assessment, and checked quality of statistical analysis, performed part of the writing or editing, made an intellectual contribution to the review update, and approved the final version of the review update prior to submission. Natalie Blencowe contributed to the update of this review, checked the quality of data extraction, undertook and checked quality assessment, performed part of the writing or editing, made an intellectual contribution to the review update, and approved the final version of the review update prior to submission. Thomas KG Milne contributed to the update of this review, checked the quality of data extraction, undertook and checked quality assessment, made an intellectual contribution to the review update, and approved the final version of the review update prior to submission. Barnaby Reeves contributed to the update of this review, checked the eligibility of additional studies, performed part of the writing or editing, made an intellectual contribution to the review update, and approved the final version of the review update prior to submission. Jane Blazeby contributed to the update of this review, checked the quality of data extraction, performed part of the writing or editing, made an intellectual contribution to the review update, and approved the final version of the review update prior to submission. Nicky Cullum (Editor): edited the review and the updated reviews, advised on methodology, interpretation and review content. Approved the final review and the updated reviews prior to submission. Gill Rizzello and Sally Bell‐Syer (Managing Editors) : co‐ordinated the editorial process. Edited the review and updated reviews. Ruth Foxlee designed the search strategy and Reetu Child ran the searches for this updated review.
Jo Dumville: I receive research funding from the NIHR for the production of systematic reviews focusing on high priority Cochrane reviews in the prevention and treatment of wounds. Trish Gray: none known Catherine J Walter: none known. Catherine Sharp: none known. Tamara Page: none known. Rhiannon Macefield: none known. Natalie Blencowe: none known. Thomas KG Milne: none known. Barnaby Reeves is funded (both part salary and research consumables) in part by the NIHR Bristol Cardiovascular Biomedical Research Unit. Jane Blazby: none known. References to studies included in this reviewBennett 2013 {published data only}
Biffi 2012 {published data only}
Burke 2012 {published data only}
Cosker 2005 {published data only}
De Win 1998 {published data only}
Dickinson Jennings 2015 {published data only}
Gardezi 1983 {published data only}
Hewlett 1996 {published data only}
Holm 1998 {published data only}
Kriegar 2011 {published data only}
Langlois 2015 {published data only}
Law 1987 {published data only}Lawrentschuk 2002 {published data only}
Martin‐Trapero 2013 {published data only}
Michie 1994 {published data only}
Moshakis 1984 {published data only}
Ozaki 2015 {published data only}
Persson 1995 {published data only}
Phan 1993 {published data only}
Politano 2011 {published data only}
Prather 2011 {published data only}
Ravnskog 2011 {published data only}
Rohde 1979 {published data only}
Ruiz‐Tovar 2015 {published data only}
Shinohara 2008 {published data only}
Siah 2011 {published data only}
Vogt 2007 {published data only}
Wikblad 1995 {published data only}
Wynne 2004 {published data only}
References to studies excluded from this reviewAbejon 2012 {published data only}
Abejon 2013 {published data only}
Ajao 1977 {published data only}
Al‐Belasy 2003 {published data only}
Allan 1996 {published data only}
Alsbjorn 1990 {published data only}
Anonymous 2013 {published data only}
Baker 1977 {published data only}
Blondeel 2004 {published data only}
Borgognoni 2000 {unpublished data only}
Borkar 2011 {published data only}
Boyce 1995 {published data only}
Brehant 2009 {published data only}
Cabrales 2014 {published data only}
Choi 2005 {published data only}
Chou 2010 {published data only}
Chrintz 1989 {unpublished data only}
Colom Majan 2002 {published data only}
Decaillet 1998 {published data only}
Dell 2001 {published data only}
Dillon 2008 {published data only}
Di Maggio 1994 {published data only}
Dixon 2006 {published data only}
Dobbelaere 2015 {published data only}
Dosseh Ekoue 2008 {published data only}
Edwards 1967 {published data only}
Eymann 2010 {published data only}
Fries 2014 {published data only}
Furrer 1993 {published data only}
Garne 1989 {published data only}
Gbolahan 2015 {published data only}
Giri 2004 {published data only}
Gonzalez 2002 {published data only}
Grauhan 2010 {published data only}
Grover 2015 {published data only}
Guilbaud 1993 {published data only}
Guillotreau 1996 {published data only}
Gupta 1991 {published data only}
Heal 2009 {published data only}
Hermans 2000 {published data only}
Hirose 2002 {published data only}
Hutchinson 1997 {published data only}
Igarza 1997 {unpublished data only}
Johannesson 2008 {published data only}
Juergens 2011 {published data only}
Kadar 2015 {published data only}
Kiefer 2016 {published data only}
Lambiris 1979 {published data only}
Mandy 1985 {published data only}
Marinovic 2010 {published data only}
Martin‐Garcia 2005 {published data only}
Maw 1997 {published data only}
McVeigh 2011 {published data only}
Merei 2004 {published data only}
Meylan 2001 {published data only}
Milne 1999 {published data only}
Moore 1997 {unpublished data only}
Morales 2006 {published data only}
Müller 1993 {unpublished data only}
Nearuy 2000 {unpublished data only}
Palao i Domenech 2008 {published data only}
Palao i Domenech 2009 {published data only}
Parvizi 2013 {published data only}
Pastorfide 1989 {published data only}
Piromchai 2008 {published data only}
Pizarro Sule 2001 {published data only}
Ponnighaus 1999 {published data only}
Ravenscroft 2006 {published data only}
Reinicke 1990 {published data only}
Ridley 2016 {published data only}
Robson 2012 {published data only}
Romero 2011 {published data only}
Rosenfeldt 2003 {published data only}
Rushbrook 2014 {published data only}
Schwartz 2014 {published data only}
Segers 2007 {published data only}
Shamiyeh 2001 {published data only}
Sheppard 2014 {published data only}
Shima 1998 {published data only}
Signorini 2007 {published data only}
Singer 2002 {published data only}
Sinha 2001 {published data only}
Slawson 2002 {published data only}
Sondergaard 1982 {published data only}
Stanirowski 2016a {published data only}
Stanirowski 2016b {published data only}
Staveski 2013 {published data only}
Staveski 2016 {published data only}
Terrill 2000 {published data only}
Teshima 2009 {published data only}
Tofuku 2012 {published data only}
Torra i Bou 2013 {published data only}
Ubbink 2008 {published data only}
Valente 2008 {published data only}
Widgerow 2009 {published data only}
Wipke‐Tevis 1993 {unpublished data only}
Wipke‐Tevis 1998 {published data only}
Yamanaka 2012 {published data only}
Yang 2013 {published data only}
References to studies awaiting assessmentGoharshenasan 2016 {published data only}
Siddiqui 2016 {published data only}
Springer 2015 {published data only}
References to ongoing studiesISRCTN06792113 {published data only}
{"type":"clinical-trial","attrs":{"text":"NCT02619773","term_id":"NCT02619773"}}NCT02619773 {published data only}
{"type":"clinical-trial","attrs":{"text":"NCT02771015","term_id":"NCT02771015"}}NCT02771015 {published data only}
{"type":"clinical-trial","attrs":{"text":"NCT02904200","term_id":"NCT02904200"}}NCT02904200 {published data only}
Additional referencesAllegranzi 2016
Astagneau 2009
BNF 2016
Bruce 2001
Button 2010
de Lissovoy 2009
Deeks 2002
Deeks 2011
Gibbons 2011
Goldman 1992
GRADE 2013
Health Protection Agency 2002
Higgins 2003Higgins 2011
Horan 2008
Hróbjartsson 2012
Lefebvre 2011
McLaws 2000
NICE 2008
Plowman 2001
RevMan 2014 [Computer program]
Schulz 2010
Schünemann 2011a
Schünemann 2011b
SIGN 2015
Smyth 2008
Sterne 2011
References to other published versions of this reviewWalter 2012
Articles from The Cochrane Database of Systematic Reviews are provided here courtesy of Wiley |