Clinical trial NCT00494793: Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction
Official title: Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction - Prospective Study of a Novel Technique for Open Abdomen Closure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Abdomen
Fascial Closure
Keywords: Open abdomen
Fascial closure
Vacuum assisted wound closure
Mesh
Abdominal compartment syndrome
Intraabdominal pressure
Incisional hernia
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
name: Gävle Hospital
name: Falu Hospital
name: KCI Europe Holding B.V.
name: The Swedish Research Council
First posted: 2007-07-02
Enrollment: 111
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary fascial closure rate
timeFrame: 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
timeFrame: 5 years
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Department of Surgery, Falu Hospital
city: Gävle
country: Sweden
facility: Department of Surgery, Gävle Hospital
city: Malmö
country: Sweden
facility: Department of Surgery, Malmö University Hospital
city: Malmö
country: Sweden
facility: Department of Vascular Surgery, Malmö University Hospital
city: Uppsala
country: Sweden
facility: Department of Surgery, Uppsala University Hospital
Study officials:
affiliation: Department of Surgery, Malmö University Hospital, Sweden
name: Ulf Petersson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjarnason T, Montgomery A, Ekberg O, Acosta S, Svensson M, Wanhainen A, Bjorck M, Petersson U. One-year follow-up after open abdomen therapy with vacuum-assisted wound closure and mesh-mediated fascial traction. World J Surg. 2013 Sep;37(9):2031-8. doi: 10.1007/s00268-013-2082-x.
citation: Sorelius K, Wanhainen A, Acosta S, Svensson M, Djavani-Gidlund K, Bjorck M. Open abdomen treatment after aortic aneurysm repair with vacuum-assisted wound closure and mesh-mediated fascial traction. Eur J Vasc Endovasc Surg. 2013 Jun;45(6):588-94. doi: 10.1016/j.ejvs.2013.01.041. Epub 2013 Mar 1.