Overview

This trial is active, not recruiting.

Conditions open abdomen, fascial closure
Treatment vawc and mesh mediated fascial traction
Sponsor Skane University Hospital
Collaborator Uppsala University Hospital
Start date February 2006
End date November 2009
Trial size 111 participants
Trial identifier NCT00494793, EPNLund 564/2005

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Frequency of primary fascial closure
time frame: 2 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Clinical Multicenter Trial Evaluating a Combination of Mesh Mediated Fascial Traction and Vacuum for Closure of the Open Abdomen
Principal investigator Ulf Petersson, MD, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2010.
Information provided to ClinicalTrials.gov by Skane University Hospital.