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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | September 12, 2005 | ||||
| Start Date ICMJE | January 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Time to complete closure | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Platelets in Acute Wounds: A Pilot Study (PAWS) | ||||
| Official Title ICMJE | Platelets in Acute Wounds: A Pilot Study (PAWS) | ||||
| Brief Summary | Comparison of wound healing treatments; platelet gel vs. control |
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| Detailed Description | Comparison of autologous platelet gel to a control treatment in acute wounds, specifically punch biopsy wounds. Eight patients included in this pilot/feasibility study. Wound healing evaluated over 6 months for wound closure and long term outcome. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Wounds | ||||
| Intervention ICMJE | Procedure: application of autologous platelet gel | ||||
| 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 | Completed | ||||
| Enrollment ICMJE | 8 | ||||
| Completion Date | August 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Healthy non-smokers, >18 years of age, BMI<30 - Exclusion Criteria: Smokers, obese, keloid formers, bleeding disorders, medications - |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00199992 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | APG-01-02-05 | ||||
| Study Sponsor ICMJE | Medtronic | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Medtronic | ||||
| Verification Date | September 2005 | ||||
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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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