Open Access Study protocol

Prevention of abdominal wound infection (PROUD trial, DRKS00000390): study protocol for a randomized controlled trial

Ulrike Heger1, Sabine Voss1, Phillip Knebel1, Colette Doerr-Harim1, Jens Neudecker2, Christoph Schuhmacher3, Eugen Faist4, Markus K Diener1, Meinhard Kieser5, Christoph M Seiler1 and Markus W Büchler1*

Author Affiliations

1 Study Centre of the German Surgical Society, Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany

2 Department of General, Visceral, Vascular, and Thoracic Surgery, Campus Charité Mitte, Charitéplatz 1, 10117 Berlin, Germany

3 Department of Surgery, Klinikum rechts der Isar, Technische Universität München, Ismaningerstr. 22, 81675 München, Germany

4 Department of Surgery, Klinikum Grosshadern, Ludwig Maximilians University Munich, Marchioninistraße 15, 81377 München, Germany

5 Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 305, 69120 Heidelberg, Germany

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Trials 2011, 12:245  doi:10.1186/1745-6215-12-245

Published: 21 November 2011

Abstract

Background

Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating.

Methods/Design

The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available.

Discussion

The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity.

Trial Registration

The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390).