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

Open Abdomen Clinical Trial

— ABDOVAC  

Official title:

Vacuum-Therapy in Open Abdomen Treatment - Randomized Pilot-trial Comparing Fascial Closure and Survival With "Vacuum-Pack"-Technique vs. "Abdominal Dressing"

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00834314
• Other study ID #: 2008-291 M-MA
• Status: Terminated
• Phase: N/A
• First received: February 2, 2009
• Last updated: December 7, 2015
• Start date: February 2010
• Est. completion date: May 2014

Study information

• Verified date: December 2015
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Open Abdomen
• Temporary Abdominal Closure

Intervention

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).
• 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/#

Locations

Country	Name	City	State
Germany	University Medical Centre - Surgical Department	Mannheim	Baden-Wuerttemberg

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim	German Research Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. Epub 2007 Mar 26. — View Citation

Brock WB, Barker DE, Burns RP. Temporary closure of open abdominal wounds: the vacuum pack. Am Surg. 1995 Jan;61(1):30-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure of delayed abdominal fascial closure (non-prevented ventral hernia) and/or in-hospital-death of any cause (combined primary outcome)		until end of vacuum-therapy or death	No
Secondary	vacuum-therapy-related morbidity/complications		until hospital dismissal or death	Yes
Secondary	length of vacuum-therapy		until end of vacuum-therapy or death	No
Secondary	costs of vacuum-therapy		until end of vacuum-therapy or death	No
Secondary	total length of ICU-stay		until end of ICU-therapy or death	No
Secondary	post-dismissal health-related quality of life (SF36 and EQ-5D questionnaire)		12 weeks after hospital dismissal	No
Secondary	recurrent hernia/abdominal wall dehiscence after initial facial closure during hospital stay		12 weeks post hospital dismissal	No

External Links

•   Description of abdominal-dressing-technique; KCI-International company