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

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ClinicalTrials.gov Identifier: NCT00834314
Recruitment Status : Terminated (extended obligations of amended medical device law in Germany 2010 did not allow to continue and complete the trial due to budget limitation)
First Posted : February 3, 2009
Last Update Posted : December 8, 2015
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Prof Dr. Stefan Post, Universitätsmedizin Mannheim

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.


Condition or disease Intervention/treatment Phase
Open Abdomen Temporary Abdominal Closure Procedure: Vacuum-Pack-technique for temporary abdominal closure Procedure: Abdominal-dressing-technique for temporary abdominal closure Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
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"
Study Start Date : February 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

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 Name: V.A.C.® Abdominal Dressing System




Primary Outcome Measures :
  1. 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 :
  1. vacuum-therapy-related morbidity/complications [ Time Frame: until hospital dismissal or death ]
  2. length of vacuum-therapy [ Time Frame: until end of vacuum-therapy or death ]
  3. costs of vacuum-therapy [ Time Frame: until end of vacuum-therapy or death ]
  4. total length of ICU-stay [ Time Frame: until end of ICU-therapy or death ]
  5. post-dismissal health-related quality of life (SF36 and EQ-5D questionnaire) [ Time Frame: 12 weeks after hospital dismissal ]
  6. recurrent hernia/abdominal wall dehiscence after initial facial closure during hospital stay [ Time Frame: 12 weeks post hospital dismissal ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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