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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 (BaFo)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Comparing the Number of Surgical Site Infections focused on measuring Surgical site infections, Covering the abdominal wound edge in laparotomies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Surgery and Institute of Statistics Klinikum rechts der Isar der Technischen Universität München

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Surgical site infections

Secondary Outcome Measures

Body-Temperature during Operation

Full Information

First Posted
August 11, 2010
Last Updated
September 19, 2017
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT01181206
Brief Title
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
Acronym
BaFo
Official Title
Standard-Bauchwandabdeckung Mit Bauchtüchern vs. Abdeckung Mittels ringförmiger Folie: Eine Doppelblinde Randomisiert-kontrollierte Studie
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
516 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs
Primary Outcome Measure Information:
Title
Surgical site infections
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Body-Temperature during Operation
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmut Friess, M.D.
Organizational Affiliation
Department of Surgery, Klinikum rechts der Isar der Technischen Universität München
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joerg Kleeff, M.D.
Organizational Affiliation
Department of Surgery, Klinikum rechts der Isar der Technischen Universität München
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery and Institute of Statistics Klinikum rechts der Isar der Technischen Universität München
City
München
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25379844
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.
Results Reference
derived
PubMed Identifier
22587425
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.
Results Reference
derived

Learn more about this trial

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

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