NCT00834314

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
12 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

December 8, 2015

Status Verified

December 1, 2015

Enrollment Period

4.2 years

First QC Date

February 2, 2009

Last Update Submit

December 7, 2015

Conditions

Open AbdomenTemporary Abdominal Closure

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • vacuum-therapy-related morbidity/complications

    until hospital dismissal or death

  • length of vacuum-therapy

    until end of vacuum-therapy or death

  • costs of vacuum-therapy

    until end of vacuum-therapy or death

  • total length of ICU-stay

    until end of ICU-therapy or death

  • post-dismissal health-related quality of life (SF36 and EQ-5D questionnaire)

    12 weeks after hospital dismissal

  • +1 more secondary outcomes

Study Arms (2)

Vacuum-pack

EXPERIMENTAL

see Interventions

Procedure: Vacuum-Pack-technique for temporary abdominal closure

Abdominal dressing

ACTIVE COMPARATOR

see Interventions

Procedure: Abdominal-dressing-technique for temporary abdominal closure

Interventions

Vacuum-Pack-technique for temporary abdominal closurePROCEDURE

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).

Vacuum-pack
Abdominal-dressing-technique for temporary abdominal closurePROCEDURE

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
Abdominal dressing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre - Surgical Department

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Related Publications (2)

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

    PMID: 7832378BACKGROUND

  • 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.

    PMID: 17481484BACKGROUND

Related Links

Study Officials

  • Stefan Post, Prof. Dr.

    University Medical Center Mannheim, Germany, Surgical Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr., Director of Surgical Department

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 3, 2009

Study Start

February 1, 2010

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

December 8, 2015

Record last verified: 2015-12

Locations

DE(1)