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| Name | Class |
|---|---|
| Uppsala University Hospital | OTHER |
| Gävle Hospital | OTHER |
| Falu Hospital | OTHER |
| KCI Europe Holding B.V. |
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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.
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:
Primary endpoint:
Frequency of primary fascial closure.
Secondary endpoints:
Duration of the study:
3-5 years. Enrollment of open abdomen cases.
Follow-up schedule for patients:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAWC and mesh mediated fascial traction | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAWC and mesh mediated fascial traction | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Primary fascial closure rate | Primary fascial closure rate with the technique | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulf Petersson, MD, PhD | Department of Surgery, Malmö University Hospital, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Falu Hospital | Falun | 791 82 | Sweden | |||
| Department of Surgery, Gävle Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23703638 | Derived | 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. | |
| 23465456 | Derived | 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. |
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| ID | Term |
|---|---|
| D059325 | Intra-Abdominal Hypertension |
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D003161 | Compartment Syndromes |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D014652 | Vascular Diseases |
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| INDUSTRY |
| The Swedish Research Council | OTHER_GOV |
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|
| Gävle |
| 801 87 |
| Sweden |
| Department of Surgery, Malmö University Hospital | Malmö | 205 02 | Sweden |
| Department of Vascular Surgery, Malmö University Hospital | Malmö | 205 02 | Sweden |
| Department of Surgery, Uppsala University Hospital | Uppsala | 751 85 | Sweden |
| D002318 |
| Cardiovascular Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |