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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00494793
Enrollment
111
Registered
2007-07-02
Start date
2006-04-01
Completion date
2015-04-01
Last updated
2017-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fascial Closure, Open Abdomen

Keywords

Open abdomen, Fascial closure, Vacuum assisted wound closure, Mesh, Abdominal compartment syndrome, Intraabdominal pressure, Incisional hernia

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.

Interventions

PROCEDUREVAWC 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

Sponsors

Uppsala University Hospital
CollaboratorOTHER
Gävle Hospital
CollaboratorOTHER
Falu Hospital
CollaboratorOTHER
KCI Europe Holding B.V.
CollaboratorINDUSTRY
The Swedish Research Council
CollaboratorOTHER_GOV
Skane University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Primary fascial closure rate2 monthsPrimary fascial closure rate with the technique

Secondary

MeasureTime frameDescription
Factors associated with failure of fascial closure and in-hospital mortality, abdominal pressure, duration of treatment with open abdomen, frequency of incisional hernia development5 yearsEarly, intermediate and late outcomes

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026