An interventional study of VAWC and mesh mediated fascial traction in Open Abdomen and Fascial Closure, sponsored by Skane University Hospital. Completed at 5 sites in Sweden. Per ClinicalTrials.gov, last updated 2017-12-29.
Sponsored by Skane University Hospital · Not applicable, Interventional, and Treatment
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.
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:
Skane University Hospital is the lead sponsor of 71 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Primary fascial closure rate with the technique
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
Early, intermediate and late outcomes
Time frame: 5 years
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Skane University Hospital