Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction - Prospective Study of a Novel Technique for Open Abdomen Closure

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Uppsala University Hospital
Gävle Hospital
Falu Hospital
Kinetic Concepts, Inc.
The Swedish Research Council
Information provided by:
Skane University Hospital
ClinicalTrials.gov Identifier:
NCT00494793
First received: June 29, 2007
Last updated: September 24, 2010
Last verified: September 2010

June 29, 2007
September 24, 2010
February 2006
November 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
Factors associated with failure of fascial closure and in-hospital mortality, 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 ]
Not Provided
Not Provided
 
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:

  • study of factors associated with failure of fascial closure and in-hospital mortality,
  • 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
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Open Abdomen
  • Fascial Closure
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

Other Names:
  • KCI Abdominal dressing
  • Polypropylene mesh
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
111
November 2014
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • open abdomen patients treated otherwise
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00494793
EPNLund 564/2005
No
Ulf Petersson MD, PhD, Dept of Surgery Malmö Univ Hosp, University of Lund, Malmö Sweden
Skane 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
Skane University Hospital
September 2010

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