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

Universitätsmedizin Mannheim

Status: Terminated

Conditions: Open Abdomen; Temporary Abdominal Closure

Treatments: Procedure: Vacuum-Pack-technique for temporary abdominal closure; Procedure: Abdominal-dressing-technique for temporary abdominal closure

Study type: Interventional

Funder types: Other

Identifiers

NCT00834314

2008-291 M-MA

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Vacuum-pack

Experimental group

Description:

see Interventions

Treatment:

Procedure: Vacuum-Pack-technique for temporary abdominal closure

Abdominal dressing

Active Comparator group

Description:

see Interventions

Treatment:

Procedure: Abdominal-dressing-technique for temporary abdominal closure