NCT01181206CompletedNot Applicable
Standard-Bauchwandabdeckung Mit Bauchtüchern vs. Abdeckung Mittels ringförmiger Folie: Eine Doppelblinde Randomisiert-kontrollierte Studie
Technical University of Munich2 sites in 1 country516 target enrollmentStarted: August 1, 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 516
- Locations
- 2
- Primary Endpoint
- Surgical site infections
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm 1
Active Comparator
Intervention: Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs (Procedure)
Arm 2
Active Comparator
Intervention: Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs (Procedure)
Outcomes
Primary Outcomes
Surgical site infections
Time Frame: 3 years
Secondary Outcomes
- Body-Temperature during Operation(3 years)
Investigators
Study Sites (2)
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