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extended obligations of amended medical device law in Germany 2010 did not allow to continue and complete the trial due to budget limitation
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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
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The primary purpose of the study is to determine whether two vacuum-wound-dressing techniques (the so called "abdominal dressing" versus "vacuum-pack-technique") are equally effective in the treatment of open abdomen.
Secondary purpose is the comparison of feasibility and economic aspects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vacuum-pack | Experimental | see Interventions |
|
| Abdominal dressing | Active Comparator | see Interventions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vacuum-Pack-technique for temporary abdominal closure | Procedure | Negative-pressure-wound-therapy applying a method described by Brock, Barker et al 1995: "Temporary Closure of Open Abdominal Wounds - the Vacuum Pack" (see citations). |
| Measure | Description | Time Frame |
|---|---|---|
| Failure of delayed abdominal fascial closure (non-prevented ventral hernia) and/or in-hospital-death of any cause (combined primary outcome) | until end of vacuum-therapy or death |
| Measure | Description | Time Frame |
|---|---|---|
| vacuum-therapy-related morbidity/complications | until hospital dismissal or death | |
| length of vacuum-therapy | until end of vacuum-therapy or death | |
| costs of vacuum-therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Post, Prof. Dr. | University Medical Center Mannheim, Germany, Surgical Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre - Surgical Department | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7832378 | Background | Brock WB, Barker DE, Burns RP. Temporary closure of open abdominal wounds: the vacuum pack. Am Surg. 1995 Jan;61(1):30-5. | |
| 17481484 | Background | Barker DE, Green JM, Maxwell RA, Smith PW, Mejia VA, Dart BW, Cofer JB, Roe SM, Burns RP. Experience with vacuum-pack temporary abdominal wound closure in 258 trauma and general and vascular surgical patients. J Am Coll Surg. 2007 May;204(5):784-92; discussion 792-3. doi: 10.1016/j.jamcollsurg.2006.12.039. Epub 2007 Mar 26. |
| Label | URL |
|---|---|
| Description of abdominal-dressing-technique; KCI-International company | View source |
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| Abdominal-dressing-technique for temporary abdominal closure | Procedure | Negative-pressure-wound-therapy for temporary abdominal closure applying a device of KCI International (V.A.C.® Abdominal Dressing System). see: http://www.kci-medical.com/kci/corporate/kcitherapies/vactherapy/dressings/abdominal/# |
|
|
| until end of vacuum-therapy or death |
| total length of ICU-stay | until end of ICU-therapy or death |
| post-dismissal health-related quality of life (SF36 and EQ-5D questionnaire) | 12 weeks after hospital dismissal |
| recurrent hernia/abdominal wall dehiscence after initial facial closure during hospital stay | 12 weeks post hospital dismissal |