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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 3Mâ„¢ Steri-Drapeâ„¢ Wound Edge Protector.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator |
| |
| Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Arm 1: Covering with approved abdominal 3Mâ„¢ Steri-Drapeâ„¢ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infections | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Body-Temperature during Operation | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery and Institute of Statistics Klinikum rechts der Isar der Technischen Universität München | München | Bavaria | 81675 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25379844 | Derived | 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. | |
| 22587425 |
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| Derived |
| 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. |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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