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| Tracking Information | |||||||||
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| First Received Date ICMJE | June 29, 2007 | ||||||||
| Last Updated Date | February 9, 2009 | ||||||||
| Start Date ICMJE | February 2006 | ||||||||
| Estimated Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Frequency of primary fascial closure [ Time Frame: 2 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Frequency of primary fascial closure [ Time Frame: 2 months ] | ||||||||
| Change History | Complete list of historical versions of study NCT00494793 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
SOFA score, abdominal pressure, duration of treatment with open abdomen, frequency of incisional hernia development [ Time Frame: 5 years ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
SOFA score, abdominal pressure, duration of treatment with open abdomen, frequency of incisional hernia development [ Time Frame: 5 years ] | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction - Prospective Study of a Novel Technique for Open Abdomen Closure | ||||||||
| Official Title ICMJE | Clinical Multicenter Trial Evaluating a Combination of Mesh Mediated Fascial Traction and Vacuum for Closure of the Open Abdomen | ||||||||
| 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. |
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| 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:
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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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Procedure: VAWC and mesh mediated fascial traction | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | May 2014 | ||||||||
| Estimated Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Sweden | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00494793 | ||||||||
| Responsible Party | Ulf Petersson MD, PhD, Dept of Surgery Malmö Univ Hosp, University of Lund, Malmö Sweden | ||||||||
| Study ID Numbers ICMJE | EPNLund 564/2005 | ||||||||
| Study Sponsor ICMJE | Malmö University Hospital | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Malmö University Hospital | ||||||||
| Verification Date | February 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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