Evidence map›Paper›PMID 23903454›Full record

Trial reportBMJ (Clinical research ed.)2013

Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial).

Thomas D Pinkney, Melanie Calvert, David C Bartlett, Adrian Gheorghe, Val Redman, George Dowswell, William Hawkins, Tony Mak, Haney Youssef, Caroline Richardson and 7 more

2 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ (Clinical research ed.), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 119 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
119citing papers in PubMed, 18 pooled it
20.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02662231 completednot on this mapstarted 2016, after this paper: background citation

Determining the Worldwide Epidemiology of Surgical Site Infections After Gastrointestinal Surgery

TypeobservationalSponsorUniversity of EdinburghRan2016 to 2016Enrolled12,539ConditionsSurgical Wound InfectionArmsEmergency, or elective gastrointestinal resection
NCT03170843 nacompletednot on this mapstarted 2017, after this paper: background citation

Randomized Controlled Trial to Evaluate the Effectiveness and Efficacy of a Sterile Circular Polyethylene Drape Compared to Conventional Surgical Dressing in Prevention of Surgical Site Infection

TypeinterventionalSponsorSaint Vincent's Hospital, KoreaRan2017 to 2022Enrolled457ConditionsSurgical Wound InfectionArmsuse of plastic ring wound retractor
3 · Its place in the literature

Who cites it

119 citing papers in PubMed, 18 syntheses or guidelines pooled it, 270 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. A Systematic Review of Health-Related Quality-of-Life Measurement in Patients With Acute Bacterial Skin and Skin Structure Infections.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Pooled it
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  13. APSIC guidelines for the prevention of surgical site infections.Antimicrobial resistance and infection control · 2019
    Guideline
  14. Pooled it
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  19. Alexis O-ring wound retractor versus traditional metal retractors for the prevention of postcaesarean surgical site infections.South African family practice : official journal of the South African Academy of Family Practice/Primary Care · 2023
    Trial
  20. Trial

59 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 3 institutions in 1 country.

Thomas D PinkneyWest Midlands Research Collaborative, Old Queen Elizabeth Hospital, Edgbaston, Birmingham, UK.
Melanie Calvert
David C Bartlett
Adrian Gheorghe
Val Redman
George Dowswell
William Hawkins
Tony Mak
Haney Youssef
Caroline Richardson
Steven Hornby
Laura Magill
Richard Haslop
Sue Wilson
Dion Morton
West Midlands Research Collaborative
ROSSINI Trial Investigators
Queen Elizabeth Hospital · GBUniversity of Birmingham · GBCancer Research UK Clinical Trials Unit · GB

Funding

Department of Health PB-PG-1208-18234Medical Research Council G0800808
6 · The paper itself

Abstract

objectiveTo determine the clinical effectiveness of wound edge protection devices in reducing surgical site infection after abdominal surgery.

designMulticentre observer blinded randomised controlled trial.

participantsPatients undergoing laparotomy at 21 UK hospitals.

interventionsStandard care or the use of a wound edge protection device during surgery.

main outcome measuresSurgical site infection within 30 days of surgery, assessed by blinded clinicians at seven and 30 days and by patient's self report for the intervening period. Secondary outcomes included quality of life, duration of stay in hospital, and the effect of characteristics of the patient and operation on the efficacy of the device.

results760 patients were enrolled with 382 patients assigned to the device group and 378 to the control group. Six patients in the device group and five in the control group did not undergo laparotomy. Fourteen patients, seven in each group, were lost to follow-up. A total of 184 patients experienced surgical site infection within 30 days of surgery, 91/369 (24.7%) in the device group and 93/366 (25.4%) in the control group (odds ratio 0.97, 95% confidence interval 0.69 to 1.36; P=0.85). This lack of benefit was consistent across wound assessments performed by clinicians and those reported by patients and across all secondary outcomes. In the secondary analyses no subgroup could be identified in which there was evidence of clinical benefit associated with use of the device.

conclusionsWound edge protection devices do not reduce the rate of surgical site infection in patients undergoing laparotomy, and therefore their routine use for this role cannot be recommended.

trial registrationCurrent Controlled Trials ISRCTN 40402832.

Indexed as

Surgical DrapesAbdomenAgedConfidence IntervalsHumansLength of StayMiddle AgedOdds RatioPlasticsQuality of LifeSingle-Blind MethodSurgical Wound InfectionPlastics

Identifiers

PMID23903454
PMCPMC3805488
OpenAlexW2095773368

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.