Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction
NCT ID: NCT00494793
Last Updated: 2017-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
111 participants
INTERVENTIONAL
2006-04-01
2015-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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VAWC and mesh mediated fascial traction
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Uppsala University Hospital
OTHER
Gävle Hospital
OTHER
Falu Hospital
OTHER
KCI Europe Holding B.V.
INDUSTRY
The Swedish Research Council
OTHER_GOV
Skane University Hospital
OTHER
Responsible Party
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Ulf Petersson
MD, PhD, Ass prof
Principal Investigators
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Ulf Petersson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Malmö University Hospital, Sweden
Locations
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Department of Surgery, Falu Hospital
Falun, , Sweden
Department of Surgery, Gävle Hospital
Gävle, , Sweden
Department of Surgery, Malmö University Hospital
Malmo, , Sweden
Department of Vascular Surgery, Malmö University Hospital
Malmo, , Sweden
Department of Surgery, Uppsala University Hospital
Uppsala, , Sweden
Countries
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References
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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.
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.
Other Identifiers
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EPNLund 564/2005
Identifier Type: -
Identifier Source: org_study_id