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

Comparing the Number of Surgical Site Infections Clinical Trial

— BaFo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181206
• Other study ID #: TUM-Chir-002/2010
• Status: Completed
• Phase: N/A
• First received: August 11, 2010
• Last updated: September 19, 2017
• Start date: August 2010
• Est. completion date: February 2014

Study information

• Verified date: December 2012
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: February 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• 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
• Infection
• Surgical Wound Infection
• Swabs

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Surgery and Institute of Statistics Klinikum rechts der Isar der Technischen Universität München	München	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infections		3 years
Secondary	Body-Temperature during Operation		3 years