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

NCT ID: NCT00834314

Last Updated: 2015-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Open Abdomen Temporary Abdominal Closure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vacuum-pack

see Interventions

Group Type EXPERIMENTAL

Vacuum-Pack-technique for temporary abdominal closure

Intervention Type PROCEDURE

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

see Interventions

Group Type ACTIVE_COMPARATOR

Abdominal-dressing-technique for temporary abdominal closure

Intervention Type PROCEDURE

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/#

Interventions

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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).

Intervention Type 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/#

Intervention Type PROCEDURE

Other Intervention Names

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V.A.C.® Abdominal Dressing System

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

Universitätsmedizin Mannheim

OTHER

Sponsor Role lead

Responsible Party

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Prof Dr. Stefan Post

Prof. Dr., Director of Surgical Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan Post, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Mannheim, Germany, Surgical Department

Locations

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University Medical Centre - Surgical Department

Mannheim, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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

Reference Type BACKGROUND
PMID: 7832378 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17481484 (View on PubMed)

Related Links

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Other Identifiers

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2008-291 M-MA

Identifier Type: -

Identifier Source: org_study_id