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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction - Prospective Study of a Novel Technique for Open Abdomen Closure

Conditions
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Open Abdomen, Fascial Closure

Intervention / Treatment
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* Procedure: VAWC and mesh mediated fascial traction


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: VAWC and mesh mediated fascial traction<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary fascial closure rate | Primary fascial closure rate with the technique | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors associated with failure of fascial closure and in-hospital mortality, abdominal pressure, duration of treatment with open abdomen, frequency of incisional hernia development | Early, intermediate and late outcomes | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open abdomen, Fascial closure, Vacuum assisted wound closure, Mesh, Abdominal compartment syndrome, Intraabdominal pressure, Incisional hernia