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Tracking Information | |||||
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First Received Date † | July 27, 2005 | ||||
Last Updated Date | September 12, 2005 | ||||
Start Date † | July 2005 | ||||
Current Primary Outcome Measures † |
Time to 100% wound closure, measured at Days 7, 14, 21, 28, 35 | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00125086 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
Measurements of wound depth at each visit. Measurement of residual scarring at 6 months post wounding. | ||||
Descriptive Information | |||||
Brief Title † | Platelets for Acute Wound Healing | ||||
Official Title † | Platelets in Acute Wounds: A Punch Biopsy Study (PAWS II) | ||||
Brief Summary | This study will examine whether platelet gel positively affects wound healing. Platelet gel will be used to treat punch biopsy wounds and the results will be compared to results from wounds treated with a control treatment. |
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Detailed Description | Platelets contribute to the healing process in soft tissue by providing the initial hemostasis that occurs following injury, a framework for fibrin matrix formation and contribution of growth factors. According to the US National Institutes of Health, surgical procedures are considered a form of controlled injury, so many of the complications faced by surgery patients are very similar to those faced by trauma patients. Scientists are currently investigating ways to treat wounds caused by trauma, burns or surgical inventions with biological agents (i.e. growth factors) or new drugs. Growth factor priming of acute wound sites pre-activates the cellular and molecular components of tissue repair, prior to tissue injury. Objectives are aimed at gathering information to establish evidence that autologous platelet gel positively effects the healing of acute wounds. |
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Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † | Wounds | ||||
Intervention † | Device: autologous platelet gel | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* 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 † | Completed | ||||
Enrollment † | 4 | ||||
Completion Date | February 2006 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00125086 | ||||
Responsible Party | |||||
Secondary IDs †† | APG-01-0605 | ||||
Study Sponsor † | Medtronic | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Medtronic | ||||
Verification Date | September 2005 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |