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

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

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.

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Interventions

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Surgical site infections	3 years

Secondary

Measure	Time frame
Body-Temperature during Operation	3 years

Countries

Germany

Outcome results

None listed