Platelets in Acute Wounds: A Pilot Study (PAWS)
This study has been completed.
Sponsor:
Medtronic
Information provided by:
Medtronic
ClinicalTrials.gov Identifier:
NCT00199992
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | September 12, 2005 | ||||
| Start Date ICMJE | January 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| 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 | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| 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 Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Wounds | ||||
| Intervention ICMJE | Procedure: application of autologous platelet gel | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 8 | ||||
| Completion Date | August 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| 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 Number ICMJE | NCT00199992 | ||||
| Other Study ID Numbers ICMJE | APG-01-02-05 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Medtronic | ||||
| Collaborators ICMJE | Not Provided | ||||
| 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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