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| 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 |
| 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) |
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
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:
Primary endpoint:
Frequency of primary fascial closure.
Secondary endpoints:
Duration of the study:
3-5 years. Enrollment of open abdomen cases.
Follow-up schedule for patients:
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |
| 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 | |
| Principal Investigator: | Ulf Petersson, MD, PhD | Department of Surgery, Malmö University Hospital, Sweden |
More Information
| 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 |
|
Open abdomen Fascial closure Vacuum assisted wound closure Mesh |
Abdominal compartment syndrome Intraabdominal pressure Incisional hernia |
|
Compartment Syndrome Hernia Compartment Syndromes |