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

December 7, 2015 updated by: Prof Dr. Stefan Post, Universitätsmedizin Mannheim

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Wuerttemberg
      • Mannheim, Baden-Wuerttemberg, Germany, 68167
        • University Medical Centre - Surgical Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Vacuum-pack
see Interventions
Procedure: 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: Abdominal dressing
see Interventions
Procedure: Abdominal-dressing-technique for temporary abdominal closure
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/#
Other Names:
  • V.A.C.® Abdominal Dressing System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
until end of vacuum-therapy or death

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsmedizin Mannheim

Collaborators

German Research Foundation

Investigators

  • Principal Investigator: Stefan Post, Prof. Dr., University Medical Center Mannheim, Germany, Surgical Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

February 2, 2009

First Submitted That Met QC Criteria

February 2, 2009

First Posted (ESTIMATE)

February 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 8, 2015

Last Update Submitted That Met QC Criteria

December 7, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 2008-291 M-MA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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