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
  Purpose

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.


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Standard-Bauchwandabdeckung Mit Bauchtüchern vs. Abdeckung Mittels ringförmiger Folie: Eine Doppelblinde Randomisiert-kontrollierte Studie

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Surgical site infections [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Body-Temperature during Operation [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 516
Study Start Date: August 2010
Study Completion Date: February 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 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 Procedure: Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01181206

Locations
Germany
Department of Surgery and Institute of Statistics Klinikum rechts der Isar der Technischen Universität München
München, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
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
  More Information

No publications provided by Technische Universität München

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01181206     History of Changes
Other Study ID Numbers: TUM-Chir-002/2010
Study First Received: August 11, 2010
Last Updated: June 17, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität München:
Surgical site infections
Covering the abdominal wound edge in laparotomies

Additional relevant MeSH terms:
Infection
Communicable Diseases

ClinicalTrials.gov processed this record on September 22, 2014