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
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Skane University Hospital:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 111
Study Start Date: February 2006
Estimated Study Completion Date: November 2014
Primary Completion Date: November 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

    Other Names:
    • KCI Abdominal dressing
    • Polypropylene mesh
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:

  • 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.
  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494793

Locations
Sweden
Department of Surgery, Falu Hospital
Falun, Sweden, 791 82
Department of Surgery, Gävle Hospital
Gävle, Sweden, 801 87
Department of Surgery, Malmö University Hospital
Malmö, Sweden, 205 02
Department of Vascular Surgery, Malmö University Hospital
Malmö, Sweden, 205 02
Department of Surgery, Uppsala University Hospital
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Skane 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 by Skane University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ulf Petersson MD, PhD, Dept of Surgery Malmö Univ Hosp, University of Lund, Malmö Sweden
ClinicalTrials.gov Identifier: NCT00494793     History of Changes
Other Study ID Numbers: EPNLund 564/2005
Study First Received: June 29, 2007
Last Updated: September 24, 2010
Health Authority: Sweden: The National Board of Health and Welfare

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

ClinicalTrials.gov processed this record on April 23, 2014