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Sponsored by: |
Medtronic |
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Information provided by: | Medtronic |
ClinicalTrials.gov Identifier: | NCT00125086 |
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.
Condition | Intervention |
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Wounds |
Device: autologous platelet gel |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Platelets in Acute Wounds: A Punch Biopsy Study (PAWS II) |
Estimated Enrollment: | 4 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | February 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | APG-01-0605, APG-01-0605 |
Study First Received: | July 27, 2005 |
Last Updated: | September 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00125086 |
Health Authority: | United States: Institutional Review Board |
wounds healing Acute wounds healing by secondary intention |
Neoplasm Metastasis |