Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction - Prospective Study of a Novel Technique for Open Abdomen Closure
Recruitment status was: Active, not recruiting
|Open Abdomen Fascial Closure||Procedure: VAWC and mesh mediated fascial traction|
|Study Design:||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|
- Frequency of primary fascial closure [ Time Frame: 2 months ]
- 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 ]
|Study Start Date:||February 2006|
|Estimated Study Completion Date:||November 2014|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Procedure: VAWC and mesh mediated fascial traction
- KCI Abdominal dressing
- Polypropylene mesh
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.
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.
Treatment of open abdomen with other techniques.
- 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.
Frequency of primary fascial closure.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494793
|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|
|Principal Investigator:||Ulf Petersson, MD, PhD||Department of Surgery, Malmö University Hospital, Sweden|