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

Trials. 2019 Jul 2;20(1):390. doi: 10.1186/s13063-019-3492-3.

Abstract

Background: Surgical 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/design: To 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.

Discussion: If 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 registration: German Clinical Trials Register, DRKS00010047 . Registered on 05.01.2017.

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

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Abdomen / surgery*
  • Anti-Infective Agents, Local / adverse effects
  • Anti-Infective Agents, Local / therapeutic use*
  • Coated Materials, Biocompatible*
  • Elective Surgical Procedures
  • Female
  • Germany
  • Humans
  • Male
  • Prospective Studies
  • Randomized Controlled Trials as Topic
  • Surgical Wound Infection / microbiology
  • Surgical Wound Infection / prevention & control*
  • Suture Techniques / adverse effects
  • Suture Techniques / instrumentation*
  • Sutures* / adverse effects
  • Time Factors
  • Treatment Outcome
  • Triclosan / adverse effects
  • Triclosan / therapeutic use*

Substances

  • Anti-Infective Agents, Local
  • Coated Materials, Biocompatible
  • Triclosan