Skip to main content
OpenTrials
Completed

NCT Number: NCT01181206

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

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.

Completed

Looking for future studies?

Notify Me

Key information

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 Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Swabs Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery and Institute of Statistics Klinikum rechts der Isar der Technischen Universität München

München, Bavaria, 81675, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs

Procedure

Primary outcomes

  1. Surgical site infections

    Time frame: 3 years

Secondary outcomes

  1. Body-Temperature during Operation

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

Standard-Bauchwandabdeckung Mit Bauchtüchern vs. Abdeckung Mittels ringförmiger Folie: Eine Doppelblinde Randomisiert-kontrollierte Studie

Acronym: BaFo

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Aug 13, 2010
Registry last updated
Sep 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.