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
NCT ID: NCT01181206
Last Updated: 2017-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
516 participants
INTERVENTIONAL
2010-08-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Arm 1
Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs
Arm 2
Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs
Interventions
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Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Technical University of Munich
OTHER
Responsible Party
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Principal Investigators
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Helmut Friess, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Klinikum rechts der Isar der Technischen Universität München
Joerg Kleeff, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Klinikum rechts der Isar der Technischen Universität München
Locations
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Department of Surgery and Institute of Statistics Klinikum rechts der Isar der Technischen Universität München
München, Bavaria, Germany
Countries
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References
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Mihaljevic AL, Schirren R, Ozer M, Ottl S, Grun S, Michalski CW, Erkan M, Jager C, Reiser-Erkan C, Kehl V, Schuster T, Roder J, Clauer U, Orlitsch C, Hoffmann TF, Lange R, Harzenetter T, Steiner P, Michalski M, Henkel K, Stadler J, Pistorius GA, Jahn A, Obermaier R, Unger R, Strunk R, Willeke F, Vogelsang H, Halve B, Dietl KH, Hilgenstock H, Meyer A, Kramling HJ, Wagner M, Schoenberg MH, Zeller F, Schmidt J, Friess H, Kleeff J. Multicenter double-blinded randomized controlled trial of standard abdominal wound edge protection with surgical dressings versus coverage with a sterile circular polyethylene drape for prevention of surgical site infections: a CHIR-Net trial (BaFO; NCT01181206). Ann Surg. 2014 Nov;260(5):730-7; discussion 737-9. doi: 10.1097/SLA.0000000000000954.
Mihaljevic AL, Michalski CW, Erkan M, Reiser-Erkan C, Jager 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.
Other Identifiers
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TUM-Chir-002/2010
Identifier Type: -
Identifier Source: org_study_id