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

Open Abdomen Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00494793
• Other study ID #: EPNLund 564/2005
• Status: Completed
• Phase: N/A
• First received: June 29, 2007
• Last updated: December 28, 2017
• Start date: April 1, 2006
• Est. completion date: April 1, 2015

Study information

• Verified date: December 2017
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: April 1, 2015
• Est. primary completion date: August 31, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fascial Closure
• Open Abdomen

Intervention

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

Locations

Country	Name	City	State
Sweden	Department of Surgery, Falu Hospital	Falun
Sweden	Department of Surgery, Gävle Hospital	Gävle
Sweden	Department of Surgery, Malmö University Hospital	Malmö
Sweden	Department of Vascular Surgery, Malmö University Hospital	Malmö
Sweden	Department of Surgery, Uppsala University Hospital	Uppsala

Sponsors (6)

Lead Sponsor	Collaborator
Skane University Hospital	Falu Hospital, Gävle Hospital, KCI Europe Holding B.V., The Swedish Research Council, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary fascial closure rate	Primary fascial closure rate with the technique	2 months
Secondary	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