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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01181206
First received: August 11, 2010
Last updated: June 17, 2014
Last verified: December 2012

August 11, 2010
June 17, 2014
August 2010
August 2013   (final data collection date for primary outcome measure)
Surgical site infections [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Surgical site infections [ Time Frame: 3 years ]
Complete list of historical versions of study NCT01181206 on ClinicalTrials.gov Archive Site
Body-Temperature during Operation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Body-Temperature during Operation [ Time Frame: 3 years ]
Not Provided
Not Provided
 
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
Standard-Bauchwandabdeckung Mit Bauchtüchern vs. Abdeckung Mittels ringförmiger Folie: Eine Doppelblinde Randomisiert-kontrollierte Studie

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
  • 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
Procedure: Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs
  • Active Comparator: Arm 1
    Intervention: Procedure: Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs
  • Active Comparator: Arm 2
    Intervention: Procedure: Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs
Mihaljevic AL, Michalski CW, Erkan M, Reiser-Erkan C, Jäger C, Schuster T, Schuhmacher C, Kleeff J, Friess H. Standard abdominal wound edge protection with surgical dressings vs coverage with a sterile circular polyethylene drape for prevention of surgical site infections (BaFO): study protocol for a randomized controlled trial. Trials. 2012 May 15;13:57. doi: 10.1186/1745-6215-13-57.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
516
February 2014
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01181206
TUM-Chir-002/2010
No
Technische Universität München
Technische Universität München
Not Provided
Principal Investigator: Helmut Friess, M.D. Department of Surgery, Klinikum rechts der Isar der Technischen Universität München
Principal Investigator: Joerg Kleeff, M.D. Department of Surgery, Klinikum rechts der Isar der Technischen Universität München
Technische Universität München
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP