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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.
Study NCT00494793   Information provided by Malmö University Hospital
First Received: June 29, 2007   Last Updated: February 9, 2009   History of Changes

June 29, 2007
February 9, 2009
February 2006
May 2009   (final data collection date for primary outcome measure)
Frequency of primary fascial closure [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Frequency of primary fascial closure [ Time Frame: 2 months ]
Complete list of historical versions of study NCT00494793 on ClinicalTrials.gov Archive Site
SOFA score, abdominal pressure, duration of treatment with open abdomen, frequency of incisional hernia development [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
SOFA score, abdominal pressure, duration of treatment with open abdomen, frequency of incisional hernia development [ Time Frame: 5 years ]
 
Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction - Prospective Study of a Novel Technique for Open Abdomen Closure
Clinical Multicenter Trial Evaluating a Combination of Mesh Mediated Fascial Traction and Vacuum for Closure of the Open Abdomen

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.

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.
 
Interventional
Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
  • Open Abdomen
  • Fascial Closure
Procedure: VAWC and mesh mediated fascial traction
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
May 2014
May 2009   (final data collection date for primary outcome measure)

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
Both
 
No
Contact: Ulf Petersson, MD, PhD +46 40 337522 ulf.pettersson@skane.se
Contact: Stefan Acosta, MD, PhD +46 40 331000 stefan.acosta@skane.se
Sweden
 
NCT00494793
Ulf Petersson MD, PhD, Dept of Surgery Malmö Univ Hosp, University of Lund, Malmö Sweden
EPNLund 564/2005
Malmö University Hospital
  • Uppsala University Hospital
  • Gävle Hospital
  • Falu Hospital
  • Kinetic Concepts, Inc.
  • The Swedish Research Council
Principal Investigator: Ulf Petersson, MD, PhD Department of Surgery, Malmö University Hospital, Sweden
Malmö University Hospital
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP