This trial is active, not recruiting.

Conditions open abdomen, temporary abdominal closure
Treatments vacuum-pack-technique for temporary abdominal closure, abdominal-dressing-technique for temporary abdominal closure
Sponsor Universitätsmedizin Mannheim
Collaborator German Research Foundation
Start date February 2010
End date May 2014
Trial size 20 participants
Trial identifier NCT00834314, 2008-291 M-MA


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
see Interventions
vacuum-pack-technique for temporary abdominal closure
Negative-pressure-wound-therapy applying a method described by Brock, Barker et al 1995: "Temporary Closure of Open Abdominal Wounds - the Vacuum Pack" (see citations).
(Active Comparator)
see Interventions
abdominal-dressing-technique for temporary abdominal closure V.A.C.® Abdominal Dressing System
Negative-pressure-wound-therapy for temporary abdominal closure applying a device of KCI International (V.A.C.® Abdominal Dressing System). see: http://www.kci-medical.com/kci/corporate/kcitherapies/vactherapy/dressings/abdominal/#

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Vacuum-Therapy in Open Abdomen Treatment - Randomized Pilot-trial Comparing Fascial Closure and Survival With "Vacuum-Pack"-Technique vs. "Abdominal Dressing"
Principal investigator Stefan Post, Prof. Dr.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Universitätsmedizin Mannheim.