TerminatedNCT00834314ABDOVACUpdated Dec 8, 2015

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

An interventional study of Vacuum-Pack-technique for temporary abdominal closure and Abdominal-dressing-technique for temporary abdominal closure in Open Abdomen and Temporary Abdominal Closure, sponsored by Universitätsmedizin Mannheim. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-08.

Sponsored by Universitätsmedizin Mannheim · Not applicable, Interventional, and Treatment

Why this study was terminated

extended obligations of amended medical device law in Germany 2010 did not allow to continue and complete the trial due to budget limitation

Phase: Not applicable
Study type: Interventional
Enrollment: 3
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Open Abdomen
Temporary Abdominal Closure

In context

Lead sponsor

Universitätsmedizin Mannheim is the lead sponsor of 75 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients indicated for open-abdomen-treatment by responsible consultant surgeon where vacuum-technique is judged technically possible

Exclusion criteria

Exclusion Criteria:

Technical reasons
unjustified risk-benefit-ratio of manipulations necessary for application of vacuum-pack-technique or abdominal-dressing-technique

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 3 participants (actual)

Study arms

Experimental
Vacuum-pack
see Interventions
Procedure: Vacuum-Pack-technique for temporary abdominal closure
Active comparator
Abdominal dressing
see Interventions
Procedure: Abdominal-dressing-technique for temporary abdominal closure

Interventions

ProcedureVacuum-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).
ProcedureAbdominal-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/#
Also known as: V.A.C.® Abdominal Dressing System

What researchers measure

Primary outcomes

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 outcomes

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

Study locations

1 site

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

References and documents

Publications

Brock WB, Barker DE, Burns RP. Temporary closure of open abdominal wounds: the vacuum pack. Am Surg. 1995 Jan;61(1):30-5. PubMed 7832378 ↗
Barker DE, Green JM, Maxwell RA, Smith PW, Mejia VA, Dart BW, Cofer JB, Roe SM, Burns RP. Experience with vacuum-pack temporary abdominal wound closure in 258 trauma and general and vascular surgical patients. J Am Coll Surg. 2007 May;204(5):784-92; discussion 792-3. doi: 10.1016/j.jamcollsurg.2006.12.039. Epub 2007 Mar 26. PubMed 17481484 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00834314
Lead sponsor: Universitätsmedizin Mannheim
Collaborators: German Research Foundation
Responsible party: Prof Dr. Stefan Post (Prof. Dr., Director of Surgical Department, Universitätsmedizin Mannheim) — Principal investigator
First posted: Feb 3, 2009
Start date: Feb 2010
Primary completion: May 2014
Completion: May 2014
Last update: Dec 8, 2015

Study contacts

Stefan Post, Prof. Dr.

principal investigator · University Medical Center Mannheim, Germany, Surgical Department

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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