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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014