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

NCT01181206 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 516

Last updated 2017-09-21

No results posted yet for this study

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.

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

Interventions

PROCEDURE

Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs

Sponsors & Collaborators

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Helmut Friess, M.D. · Department of Surgery, Klinikum rechts der Isar der Technischen Universität München

  • Joerg Kleeff, M.D. · Department of Surgery, Klinikum rechts der Isar der Technischen Universität München

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-08-31
Completion
2014-02-28

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01181206 on ClinicalTrials.gov