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

This study has been terminated.
(extended obligations of amended medical device law in Germany 2010 did not allow to continue and complete the trial due to budget limitation)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00834314
First Posted: February 3, 2009
Last Update Posted: December 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Prof Dr. Stefan Post, Universitätsmedizin Mannheim
  Purpose

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.


Condition Intervention
Open Abdomen Temporary Abdominal Closure Procedure: Vacuum-Pack-technique for temporary abdominal closure Procedure: Abdominal-dressing-technique for temporary abdominal closure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vacuum-Therapy in Open Abdomen Treatment - Randomized Pilot-trial Comparing Fascial Closure and Survival With "Vacuum-Pack"-Technique vs. "Abdominal Dressing"

Further study details as provided by Prof Dr. Stefan Post, Universitätsmedizin Mannheim:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 3
Study Start Date: February 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: V.A.C.® Abdominal Dressing System

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00834314


Locations
Germany
University Medical Centre - Surgical Department
Mannheim, Baden-Wuerttemberg, Germany, 68167
Sponsors and Collaborators
Universitätsmedizin Mannheim
German Research Foundation
Investigators
Principal Investigator: Stefan Post, Prof. Dr. University Medical Center Mannheim, Germany, Surgical Department
  More Information

Additional Information:
Publications:
Responsible Party: Prof Dr. Stefan Post, Prof. Dr., Director of Surgical Department, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT00834314     History of Changes
Other Study ID Numbers: 2008-291 M-MA
First Submitted: February 2, 2009
First Posted: February 3, 2009
Last Update Posted: December 8, 2015
Last Verified: December 2015