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
NCT01181206 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 516
Last updated 2017-09-21
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.
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
- PROCEDURE
-
Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs
Sponsors & Collaborators
-
Technical University of Munich
lead OTHER
Principal Investigators
-
Helmut Friess, M.D. · Department of Surgery, Klinikum rechts der Isar der Technischen Universität München
-
Joerg Kleeff, M.D. · Department of Surgery, Klinikum rechts der Isar der Technischen Universität München
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-08-31
- Primary Completion
- 2013-08-31
- Completion
- 2014-02-28
Countries
- Germany
Study Locations
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