Clinical trial NCT01181206: 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
Official title: Standard-Bauchwandabdeckung Mit Bauchtüchern vs. Abdeckung Mittels ringförmiger Folie: Eine Doppelblinde Randomisiert-kontrollierte Studie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Keywords: Surgical site infections
Covering the abdominal wound edge in laparotomies
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2010-08-13
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Surgical site infections
timeFrame: 3 years
Secondary outcomes:
measure: Body-Temperature during Operation
timeFrame: 3 years
Other outcomes:
Locations:
city: München
country: Germany
facility: Department of Surgery and Institute of Statistics Klinikum rechts der Isar der Technischen Universität München
state: Bavaria
Study officials:
affiliation: Department of Surgery, Klinikum rechts der Isar der Technischen Universität München
name: Helmut Friess, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, Klinikum rechts der Isar der Technischen Universität München
name: Joerg Kleeff, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.