Do antibacterial skin sutures reduce surgical site infections after elective open abdominal surgery? - Study protocol of a prospective, randomized controlled single center trial

Trials

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[1] Department of Clinical Research, University of Basel, Clinical Trial Unit, University Hospital, Spitalstrasse 12, 4031, Basel, Switzerland;Department of General-, Visceral- and Thoracic Surgery, AGAPLESION Diakonie Hospital Rotenburg (Wuemme), Elise Averdieck-Str. 17, 27356, Rotenburg (Wuemme), Germany;Department of General-, Visceral- and Thoracic Surgery, AGAPLESION Diakonie Hospital Rotenburg (Wuemme), Elise Averdieck-Str. 17, 27356, Rotenburg (Wuemme), Germany;grid.410567.1, Department of General Surgery, University of Basel Hospital, Spitalstrasse 21, 4031, Basel, Switzerland;grid.410567.1, Department of General Surgery, University of Basel Hospital, Spitalstrasse 21, 4031, Basel, Switzerland;

关键词: Surgical site infection;    Antibacterial-coated suture material;    Triclosan;    Elective abdominal surgery;    Skin closure;   

DOI  :  10.1186/s13063-019-3492-3

来源: publisher

【 摘 要 】

BackgroundSurgical site infections (SSI) remain one of the most common complications in conventional abdominal surgery with an incidence between 4% and 19% (Sandini et al., Medicine (Baltimore) 95:e4057, 2016) in the literature. It is unclear whether the use of coated suture material for skin closure reduces the risk of SSI. In line with in-vitro results, we hypothesize that the use of antibacterial skin sutures (triclosan-coated poliglecaprone 25) reduces the rate of SSI after open abdominal surgery.Methods/designTo prevent SSI, triclosan-coated poliglecaprone 25 sutures will be tested against un-coated suture material for skin closure after elective open abdominal surgery of 364 patients. The study is planned as a single-center, prospective randomized controlled trial. Patients will be followed for 30 days after surgery to detect and document wound complications. The rate of SSI after 30 days will be analyzed in both groups.DiscussionIf we can confirm the proposed hypothesis in our study, this could be a promising and feasible approach to lower SSI after open abdominal surgery. By lowering the rate of SSI this might offer a cost-saving and morbidity-reducing procedure.Trial registrationGerman Clinical Trials Register, DRKS00010047. Registered on 05.01.2017.

【 授权许可】

CC BY