Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction
|ClinicalTrials.gov Identifier: NCT00494793|
Recruitment Status : Completed
First Posted : July 2, 2007
Last Update Posted : December 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Open Abdomen Fascial Closure||Procedure: VAWC and mesh mediated fascial traction||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||111 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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 fascial closure rate [ Time Frame: 2 months ]Primary fascial closure rate with the technique
- 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
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
|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|