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Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction

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ClinicalTrials.gov Identifier: NCT00494793
Recruitment Status : Completed
First Posted : July 2, 2007
Last Update Posted : December 29, 2017
Sponsor:
Collaborators:
Uppsala University Hospital
Gävle Hospital
Falu Hospital
KCI Europe Holding B.V.
The Swedish Research Council
Information provided by (Responsible Party):
Ulf Petersson, Skane University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Open Abdomen Fascial Closure Procedure: VAWC and mesh mediated fascial traction Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction - Prospective Study of a Novel Technique for Open Abdomen Closure
Actual Study Start Date : April 1, 2006
Actual Primary Completion Date : August 31, 2009
Actual Study Completion Date : April 1, 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
VAWC and mesh mediated fascial traction
This is a study aiming to evaluate one technique for temporary abdominal closure for open abdomen therapy in all patients applicable according to the inclusion criteria
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




Primary Outcome Measures :
  1. Primary fascial closure rate [ Time Frame: 2 months ]
    Primary fascial closure rate with the technique


Secondary Outcome Measures :
  1. 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 ]
    Early, intermediate and late outcomes



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
KCI Europe Holding B.V.
The Swedish Research Council
Investigators
Principal Investigator: Ulf Petersson, MD, PhD Department of Surgery, Malmö University Hospital, Sweden

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ulf Petersson, MD, PhD, Ass prof, Skane University Hospital
ClinicalTrials.gov Identifier: NCT00494793     History of Changes
Other Study ID Numbers: EPNLund 564/2005
First Posted: July 2, 2007    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017

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