Pilot Study Comparing Two Vacuum-wound-dressings for the Treatment of Open Abdomen - Full Text View

Sponsor:	University Hospital Mannheim
Collaborator:	German Research Foundation
Information provided by:	University Hospital Mannheim
ClinicalTrials.gov Identifier:	NCT00834314

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:	Pilot Study Comparing Two Negative-pressure Wound Dressing Systems for the Treatment of Open Abdomen: "Vacuum-pack" Versus "Abdominal Dressing"

Resource links provided by NLM:

MedlinePlus related topics: Hernia

U.S. FDA Resources

Further study details as provided by University Hospital 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:	October 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	September 2010 (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

Contacts

Contact: Florian Herrle, MD	0049-621- ext 2357	florian.herrle@umm.de
Contact: Jens-Olaf Jonescheit, MD	0049-621- ext 2357	jens-olaf.jonescheit@umm.de

Sponsors and Collaborators

University Hospital Mannheim

German Research Foundation

Investigators

Principal Investigator:

Stefan Post, Prof. Dr.

University Medical Center Mannheim, Germany, Surgical Department

More Information

Additional Information:

Description of abdominal-dressing-technique; KCI-International company This link exits the ClinicalTrials.gov site

Publications:

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

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.

Responsible Party:	Prof. Dr. Stefan Post, Director Surgical Department, University Medical Center Mannheim
ClinicalTrials.gov Identifier:	NCT00834314 History of Changes
Other Study ID Numbers:	2008-291 M-MA
Study First Received:	February 2, 2009
Last Updated:	December 24, 2009
Health Authority:	Germany: Ethics Commission

ClinicalTrials.gov processed this record on February 09, 2012