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

Study Overview
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Brief Summary
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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.

Official Title
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Vacuum-Therapy in Open Abdomen Treatment - Randomized Pilot-trial Comparing Fascial Closure and Survival With Vacuum-Pack-Technique vs. Abdominal Dressing

Conditions
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Open Abdomen, Temporary Abdominal Closure

Intervention / Treatment
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* Procedure: Vacuum-Pack-technique for temporary abdominal closure
* Procedure: Abdominal-dressing-technique for temporary abdominal closure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vacuum-pack<br>see Interventions | Procedure: Vacuum-Pack-technique for temporary abdominal closure<br>* 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).<br>|
| Active Comparator: Abdominal dressing<br>see Interventions | Procedure: Abdominal-dressing-technique for temporary abdominal closure<br>* 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/#<br>* Other names: V.A.C.® Abdominal Dressing System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vacuum-therapy-related morbidity/complications |  | until hospital dismissal or death | 
| length of vacuum-therapy |  | until end of vacuum-therapy or death | 
| costs of vacuum-therapy |  | until end of vacuum-therapy 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 | 
| recurrent hernia/abdominal wall dehiscence after initial facial closure during hospital stay |  | 12 weeks post hospital dismissal |