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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)

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ClinicalTrials.gov Identifier: NCT01181206
Recruitment Status : Completed
First Posted : August 13, 2010
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Procedure: Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 516 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Standard-Bauchwandabdeckung Mit Bauchtüchern vs. Abdeckung Mittels ringförmiger Folie: Eine Doppelblinde Randomisiert-kontrollierte Studie
Study Start Date : August 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : February 2014

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm 1 Procedure: Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs
Active Comparator: Arm 2 Procedure: Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs


Outcome Measures
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Primary Outcome Measures :
  1. Surgical site infections [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Body-Temperature during Operation [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181206


Locations
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Germany
Department of Surgery and Institute of Statistics Klinikum rechts der Isar der Technischen Universität München
München, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
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Principal Investigator: 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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01181206    
Other Study ID Numbers: TUM-Chir-002/2010
First Posted: August 13, 2010    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: December 2012
Keywords provided by Technische Universität München:
Surgical site infections
Covering the abdominal wound edge in laparotomies
Additional relevant MeSH terms:
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Infection
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes