Covering of the Abdominal Wall in Laparotomies: Differences in Surgical Site Infections Between an Approved Abdominal 3M™ Steri-Drape™ Wound Edge Protector and Standard Woven Swabs at Technische Universität München

Technical University of Munich516 enrolled

Overview

BaFo is a prospective, double-blinded randomized controlled clinical trial that assesses the numbers of surgical site infections in two different techniques of covering the abdominal wall in laparotomies. Standard covering with woven swabs is compared to a novel, approved 3M™ Steri-Drape™ Wound Edge Protector.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

516

Conditions

Comparing the Number of Surgical Site Infections Covering of the Abdominal Wall in Laparotomies With an Approved Abdominal 3M™ Steri-Drape™ Wound Edge Protector and Standard Woven Swabs

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ability to sign the informed consent * Patients older than 18 years * Abdominal operations with longitudinal / cross section with clean wounds, clean-contaminated wounds or contaminated wounds (cdc-definitions of surgical wound infections) Exclusion Criteria: * Pregnant or lactating women * Revision Operations * Operations with dirty or infected wounds (CDC definition of surgical wound infections) * Laparoscopic operations * Small operations without longitudinal- / cross-section e.g. appendectomy

Outcomes

Primary Outcomes

Surgical site infections

Time frame: 3 years

Secondary Outcomes

Body-Temperature during Operation