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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Prof Dr. Stefan Post, University Hospital Mannheim
ClinicalTrials.gov Identifier:
NCT00834314
First received: February 2, 2009
Last updated: January 9, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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"

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • vacuum-therapy-related morbidity/complications [ Time Frame: until hospital dismissal or death ] [ Designated as safety issue: Yes ]
  • length of vacuum-therapy [ Time Frame: until end of vacuum-therapy or death ] [ Designated as safety issue: No ]
  • costs of vacuum-therapy [ Time Frame: until end of vacuum-therapy or death ] [ Designated as safety issue: No ]
  • total length of ICU-stay [ Time Frame: until end of ICU-therapy or death ] [ Designated as safety issue: No ]
  • post-dismissal health-related quality of life (SF36 and EQ-5D questionnaire) [ Time Frame: 12 weeks after hospital dismissal ] [ Designated as safety issue: No ]
  • recurrent hernia/abdominal wall dehiscence after initial facial closure during hospital stay [ Time Frame: 12 weeks post hospital dismissal ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2010
Estimated Study Completion Date: August 2014
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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, University Hospital Mannheim
ClinicalTrials.gov Identifier: NCT00834314     History of Changes
Other Study ID Numbers: 2008-291 M-MA
Study First Received: February 2, 2009
Last Updated: January 9, 2014
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on April 20, 2014