Randomized Pilot Study Comparing Two Vacuum-wound-dressings for Open Abdomen Treatment

Not Applicable

Terminated

• Conditions: Open Abdomen; Temporary Abdominal Closure
• Interventions: Procedure: Vacuum-Pack-technique for temporary abdominal closure; Procedure: Abdominal-dressing-technique for temporary abdominal closure

• Registration Number: NCT00834314
• Lead Sponsor: Universitätsmedizin Mannheim

Brief Summary

The primary purpose of the study is to determine whether two vacuum-wound-dressing techniques (the so called "abdominal dressing" versus "vacuum-pack-technique") are equally effective in the treatment of open abdomen.

Secondary purpose is the comparison of feasibility and economic aspects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-02
• Study First Posted: 2009-02-03
• Study Start: 2010-02
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-07
• Last Update Posted: 2015-12-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Patients indicated for open-abdomen-treatment by responsible consultant surgeon where vacuum-technique is judged technically possible

Exclusion Criteria

• Technical reasons
• unjustified risk-benefit-ratio of manipulations necessary for application of vacuum-pack-technique or abdominal-dressing-technique

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vacuum-pack	Vacuum-Pack-technique for temporary abdominal closure	see Interventions
Abdominal dressing	Abdominal-dressing-technique for temporary abdominal closure	see Interventions

Primary Outcome Measures

Name	Time	Method
Failure of delayed abdominal fascial closure (non-prevented ventral hernia) and/or in-hospital-death of any cause (combined primary outcome)	until end of vacuum-therapy or death

Secondary Outcome Measures

Name	Time	Method
vacuum-therapy-related morbidity/complications	until hospital dismissal or death
total length of ICU-stay	until end of ICU-therapy or death
post-dismissal health-related quality of life (SF36 and EQ-5D questionnaire)	12 weeks after hospital dismissal
length of vacuum-therapy	until end of vacuum-therapy or death
costs of vacuum-therapy	until end of vacuum-therapy or death
recurrent hernia/abdominal wall dehiscence after initial facial closure during hospital stay	12 weeks post hospital dismissal

Trial Locations

Locations (1)

University Medical Centre - Surgical Department; 🇩🇪 Mannheim, Baden-Wuerttemberg, Germany