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Open Access Study protocol

Reduction of surgical site infection using a novel intervention (ROSSINI): study protocol for a randomised controlled trial

Thomas D Pinkney1, David C Bartlett12*, William Hawkins1, Tony Mak1, Haney Youssef1, Kaori Futaba1, Gareth Harrison1, Adrian Gheorghe3, Jennifer M Bradbury4, Melanie J Calvert3, George Dowswell3, Laura Magill5, Val Redman3, Sue Wilson3, David Leaper6, Dion G Morton4 and the West Midlands Research Collaborative

Author Affiliations

1 Surgical Registrar, West Midlands Deanery/West Midlands Research Collaborative, UK

2 MRC Clinical Research Fellow, NIHR Biomedical Research Unit and Centre for Liver Research, University of Birmingham, UK

3 Primary Care Clinical Research and Trials Unit, University of Birmingham, UK

4 Academic Department of Surgery, University Hospitals Birmingham, UK

5 Birmingham Clinical Trials Unit, University of Birmingham, UK

6 Emeritus Professor, University of Newcastle upon Tyne and Visiting Chair, Imperial College London, UK

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Trials 2011, 12:217  doi:10.1186/1745-6215-12-217

Published: 4 October 2011

Abstract

Background

Surgical site infection (SSI) is a common complication following abdominal surgery. It is associated with considerable morbidity and mortality, and its management results in significant cost to health services within both primary and secondary care. Some surgeons believe that the use of a wound-edge protection device may reduce the incidence of SSI. Whilst there is some encouraging evidence showing that such devices may lead to a reduction in SSI, there are no controlled trials of sufficient size or quality to support their routine use.

Methods/Design

750 patients will be recruited from around 20 surgical units within the United Kingdom. Patients undergoing laparotomy through any major abdominal incision for any indication, elective or emergency, are eligible. Patients under the age of 18, those undergoing a laparoscopic assisted procedure or who have undergone laparotomy within the previous 3 months, and those who are unable to give informed consent will be excluded. Patients will be randomised (1:1 ratio) to the use of a wound-edge protection device or no wound-edge protection device during surgery.

Follow up will consist of blinded clinical wound reviews at 5-7 days and 30-33 days postoperatively with a self-completed questionnaire covering the intervening period. Quality of life questionnaires will be completed prior to surgery and at the subsequent wound review points and information on resource usage will also be captured.

The primary outcome measure is SSI within 30 days of surgery. Secondary outcomes include the impact of the degree of wound contamination, patient comorbidity, and operative characteristics on the efficacy of a wound-edge protection device in reducing SSI and whether the use of a wound-edge protection device has an effect on health-related quality of life or length of hospital stay and is cost-effective.

Discussion

Rossini is the first multicentre observer-blinded randomised controlled trial of sufficient size and quality to establish whether the use of a wound-edge protection device in adult patients undergoing abdominal surgery leads to a lower rate of SSI. The results of this study will be used to inform current surgical practice and may potentially benefit patients undergoing surgery in the future.

Trial registration number

Current Controlled Trials ISRCTN: ISRCTN40402832