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Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet]. York (UK): Centre for Reviews and Dissemination (UK); 1995-.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet].

Systematic review of the clinical effectiveness of wound-edge protection devices in reducing surgical site infection in patients undergoing open abdominal surgery.

A Gheorghe, M Calvert, TD Pinkney, BR Fletcher, DC Bartlett, WJ Hawkins, T Mak, H Youssef, and S Wilson.

Review published: 2012.

Link to full article: [Journal publisher]

CRD summary

This review concluded that wound–edge protection devices may have been efficient for reducing postoperative surgical site infections in patients who underwent open abdominal surgery, compared with standard care. The poor quality of the evidence indicated a need for a large good quality randomised controlled trial. This seems a reliable conclusion from a well-conducted review.

Authors' objectives

To evaluate the clinical effectiveness of wound-edge protection devices in reducing surgical site infection in patients undergoing open abdominal surgery.

Searching

MEDLINE, EMBASE, CINAHL, Web of Science and Cochrane Central Register of Controlled Trials (CENTRAL) were searched in November 2010 without any language restrictions; search terms were reported. The proceedings of the annual conferences of the Association of Coloproctology of Great Britain and Ireland and the Association of Surgeons of Great Britain and Ireland were searched. References were handsearched for additional studies. Manufacturers of devices and authors of relevant articles were contacted for information.

Study selection

Eligible randomised controlled trials, controlled trials, prospective cohort studies and case-control studies had to include patients who underwent elective or emergency open abdominal surgery using a wound-edge protection device which covered the incision edges with an impervious plastic sheet. Control groups had to use standard care and studies had to have clinically defined surgical site infection as a prespecified outcome. Purely bacteriological definitions of surgical site infection were excluded.

Most studies were in gastrointestinal surgery mostly colorectal surgery, others were generic abdominal surgery or appendicectomy. Interventions were plastic drapes and the actual type varied between studies. Control groups were no wound-edge protection device, standard retraction or incise drapes. Surgical site infection was prespecified as an outcome by all studies but the definitions of surgical site infection varied and only two studies used an internationally recognised definition (Centre for Disease Control and Prevention). The remaining studies used their own definitions and some included bacteriological results. Where stated, most studies followed up patients for one month.

Study selection was performed independently by two reviewers with disagreements resolved by a consensual decision.

Assessment of study quality

Study quality was assessed using the Cochrane Collaboration's Risk of Bias tool. This covered randomisation method, allocation concealment, blinding of patients and outcome assessors, addressing incomplete outcome data, selective reporting and other bias.

Assessment was performed independently by two reviewers with disagreements resolved by a consensual decision.

Data extraction

The numbers of patients with an surgical site infection were extracted and used to calculate risk ratios (RR) with 95% confidence intervals (CI).

Data were extracted by one reviewer and checked by a second.

Methods of synthesis

Results were combined using both fixed-effect and random-effects meta-analysis. Statistical heterogeneity was assessed with the Ι² statistic. A subgroup analysis was used to look at the impact of contamination (clean, clean contaminated, contaminated and dirty surgical procedures) on the risk of an surgical site infection. Publication bias was assessed using a funnel plot.

Results of the review

Twelve studies were included (1,933 participants); ten were randomised controlled trials and two were controlled trials. All studies were considered to have been at medium or high risk of bias. Three studies had reported adequate randomisation methods, none reported adequate allocation concealment, two reported adequate blinding, four addressed incomplete outcome data, most were unclear for selective reporting, and eight studies were affected by other sources of bias (failing to report baseline comparability of groups or funding sources).

The use of wound-edge protection devices reduced the incidence of surgical site infection compared with control (RR 0.60, 95% CI 0.41 to 0.86) based on an analysis of all 12 studies with moderate heterogeneity (Ι²=54%). The result was similar when a fixed-effect model was used. The funnel plot showed some asymmetry indicating publication bias but the authors stated that this was due to two studies. Four studies reported results for the degree of contamination. The use of wound-edge protection significantly reduced SSIs in patients undergoing contaminated surgery (RR 0.37, 95% CI 0.23 to 0.61; three studies with no heterogeneity Ι²=0%) and dirty surgery (RR 0.55, 95% CI 0.36 to 0.86; three studies with moderate heterogeneity Ι²=51%). There was no difference between the groups for clean or clean contaminated surgery.

Authors' conclusions

Wound–edge protection devices may have been efficient for reducing incidence of postoperative surgical site infections in patients who underwent open abdominal surgery, compared with standard care. The poor quality of the evidence indicated a need for a large good quality randomised controlled trial.

CRD commentary

This review had clearly defined inclusion criteria for study design, intervention, patients and outcome. The literature search covered several relevant databases, proceedings of conferences and efforts to contact device manufacturers. Searching was not limited by language so risk of publication or language bias was reduced, but the authors highlighted the fact that they may have failed to find some unpublished studies. Study selection, data extraction and quality assessment were carried out by two independent reviewers to reduce error and bias.

The quality of the evidence was assessed using a recognised checklist, details were reported in full and it was used in the evaluation of the pooled analyses. The methods of meta-analysis seemed appropriate, but the subgroup results were based on a small number of studies. This was a well-conducted review and its cautious conclusion and recommendation for research seem reliable.

Implications of the review for practice and research

Practice: The authors did not make any recommendations for practice.

Research: The authors stated that there was a need for high-quality, multi-centre, randomised controlled trials with economic evaluations to assess the appropriateness of introducing wound-edge protection devices as standard practice in open abdominal surgery.

Funding

Research for Patient Benefit programme from the National Institute for Health Research.

Bibliographic details

Gheorghe A, Calvert M, Pinkney TD, Fletcher BR, Bartlett DC, Hawkins WJ, Mak T, Youssef H, Wilson S. Systematic review of the clinical effectiveness of wound-edge protection devices in reducing surgical site infection in patients undergoing open abdominal surgery. Annals of Surgery 2012; 255(6): 1017-1029. [PubMed: 22270692]

Indexing Status

Subject indexing assigned by NLM

MeSH

Abdomen /surgery; Humans; Laparotomy /instrumentation; Protective Devices; Quality Assurance, Health Care; Surgical Drapes; Surgical Wound Infection /etiology /prevention & control; Treatment Outcome; Wounds and Injuries /complications /surgery

AccessionNumber

12012028100

Database entry date

15/11/2012

Record Status

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.

CRD has determined that this article meets the DARE scientific quality criteria for a systematic review.

Copyright © 2014 University of York.

PMID: 22270692

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