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Clinical Trials/NCT00834314
NCT00834314
Terminated
Not Applicable

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

Universitätsmedizin Mannheim1 site in 1 country3 target enrollmentStarted: February 2010Last updated:
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ConditionsOpen AbdomenTemporary Abdominal Closure

Overview

Phase
Not Applicable
Status
Terminated
Enrollment
3
Locations
1
Primary Endpoint
Failure of delayed abdominal fascial closure (non-prevented ventral hernia) and/or in-hospital-death of any cause (combined primary outcome)
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

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(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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof Dr. Stefan Post

Prof. Dr., Director of Surgical Department

Universitätsmedizin Mannheim

Study Sites (1)

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