Full Text View
Tabular View
No Study Results Posted
Related Studies
Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction - Prospective Study of a Novel Technique for Open Abdomen Closure
This study is currently recruiting participants.
Verified by Malmö University Hospital, February 2009
First Received: June 29, 2007   Last Updated: February 9, 2009   History of Changes
Sponsors and Collaborators: Malmö University Hospital
Uppsala University Hospital
Gävle Hospital
Falu Hospital
Kinetic Concepts, Inc.
The Swedish Research Council
Information provided by: Malmö University Hospital
ClinicalTrials.gov Identifier: NCT00494793
  Purpose

The purpose of this multicenter trial is to prospectively evaluate a novel combination of vacuum assisted wound closure (VAWC) and mesh mediated fascial traction for closure of open abdomens.


Condition Intervention
Open Abdomen
Fascial Closure
Procedure: VAWC and mesh mediated fascial traction

Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Clinical Multicenter Trial Evaluating a Combination of Mesh Mediated Fascial Traction and Vacuum for Closure of the Open Abdomen

Resource links provided by NLM:


Further study details as provided by Malmö University Hospital:

Primary Outcome Measures:
  • Frequency of primary fascial closure [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SOFA score, abdominal pressure, duration of treatment with open abdomen, frequency of incisional hernia development [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: February 2006
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: VAWC and mesh mediated fascial traction

    The first period of 2-5 days only the abdominal VAWC dressing is applied. On day 3-10 a polypropylene mesh is sutured to the fascial edges, between the two layers of the VAWC system, and tightened.

    The VAWC dressing is changed and the mesh tightened every 2-3 days, resulting in gradual approximation of the fascial edges.

    Finally the mesh is removed and the fascia is closed

Detailed Description:

Open abdomen treatment often results in difficulties in closing the abdomen. Highest closure rates are seen with the vacuum assisted wound closure (VAWC) technique. Failures with this technique is occasionally experienced, especially in cases with severe visceral swelling needing longer treatment periods with open abdomen. A novel combination of vacuum assisted wound closure and mesh mediated fascial traction for managing the open abdomen was therefore developed and initially tested in a small pilot-like study with encouraging results with late primary closure of the abdomens in all seven patients.

In this multicenter study we prospectively evaluate the technique.

Inclusion criteria:

All patients treated with open abdomen at the 4 participating hospitals are registered, and only those patients who have commenced therapy with VAWC and mesh mediated fascial traction will be included in the study in an intention to treat model.

Exclusion criteria:

Treatment of open abdomen with other techniques.

Method:

  • The first period of 2-5 days only the abdominal VAWC dressing is applied.
  • On day 3-10 a polypropylene mesh is sutured to the fascial edges, between the two layers of the VAWC system, and tightened.
  • The VAWC dressing is changed and the mesh tightened every 2-3 days, resulting in gradual approximation of the fascial edges.
  • Finally the mesh is removed and the fascia is closed.
  • At closure the wound to suture length is registered.

Primary endpoint:

Frequency of primary fascial closure.

Secondary endpoints:

  • initial SOFA scores,
  • SOFA score variation attributable to the use of the technique,
  • abdominal pressure variation attributable to the use of the technique,
  • duration of treatment with open abdomen,
  • frequency of incisional hernia after one and five years.

Duration of the study:

3-5 years. Enrollment of open abdomen cases.

Follow-up schedule for patients:

  • Clinical evaluation at 1 and 5 years.
  • CT-examination at 1 year.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • open abdomen patients where vacuum assisted wound closure system and mesh mediated fascial traction is applicable

Exclusion Criteria:

  • open abdomen patients treated otherwise
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494793

Contacts
Contact: Ulf Petersson, MD, PhD +46 40 337522 ulf.pettersson@skane.se
Contact: Stefan Acosta, MD, PhD +46 40 331000 stefan.acosta@skane.se

Locations
Sweden
Department of Surgery, Malmö University Hospital Recruiting
Malmö, Sweden, 205 02
Contact: Ulf Petersson, MD, PhD     +46 40 337522     ulf.petersson@skane.se    
Principal Investigator: Ulf Petersson, MD, PhD            
Department of Surgery, Uppsala University Hospital Recruiting
Uppsala, Sweden, 751 85
Contact: Martin Björck, MD, PhD     +46 18 6114608     martin@bjorck.pp.se    
Principal Investigator: Martin Björck, MD, PhD            
Department of Vascular Surgery, Malmö University Hospital Recruiting
Malmö, Sweden, 205 02
Contact: Stefan Acosta, MD, PhD     +46 40 331000     stefan.acosta@skane.se    
Principal Investigator: Stefan Acosta, MD, PhD            
Department of Surgery, Gävle Hospital Recruiting
Gävle, Sweden, 801 87
Contact: Khatereh Djavani, MD     +46 26 154270     khatereh.djavani@lg.se    
Principal Investigator: Khatereh Djavani, MD            
Department of Surgery, Falu Hospital Recruiting
Falun, Sweden, 791 82
Contact: Mats Svensson, MD     +46 70 6239252     mats.svensson@ltdalarna.se    
Principal Investigator: Mats Svensson, MD            
Sponsors and Collaborators
Malmö University Hospital
Uppsala University Hospital
Gävle Hospital
Falu Hospital
Kinetic Concepts, Inc.
The Swedish Research Council
Investigators
Principal Investigator: Ulf Petersson, MD, PhD Department of Surgery, Malmö University Hospital, Sweden
  More Information

No publications provided

Responsible Party: Dept of Surgery Malmö Univ Hosp, University of Lund, Malmö Sweden ( Ulf Petersson MD, PhD )
Study ID Numbers: EPNLund 564/2005
Study First Received: June 29, 2007
Last Updated: February 9, 2009
ClinicalTrials.gov Identifier: NCT00494793     History of Changes
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Malmö University Hospital:
Open abdomen
Fascial closure
Vacuum assisted wound closure
Mesh
Abdominal compartment syndrome
Intraabdominal pressure
Incisional hernia

Study placed in the following topic categories:
Compartment Syndrome
Hernia
Compartment Syndromes

ClinicalTrials.gov processed this record on July 06, 2009