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Platelets for Acute Wound Healing - Article


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Clinical Trial: Platelets for Acute Wound Healing

This study is currently recruiting patients.
Verified by Medtronic July 2005

Sponsored by: Medtronic
Information provided by: Medtronic
ClinicalTrials.gov Identifier: NCT00125086

Purpose

This study will examine whether platelet gel positively effects wound healing. Platelet gel will be used to treat punch biopsy wounds and the results compared to results from wounds treated with a Control treatment.
Condition Intervention
Acute wounds healing by secondary intention
 Device: autologous platelet gel

MedlinePlus consumer health information 

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)

Further Study Details: 
Primary Outcomes: Time to 100% wound closure, measured at Days 7, 14, 21, 28, 35.
Secondary Outcomes: Measurements of wound depth at each visit. Measurement of residual scarring at 6 months post wounding.
Expected Total Enrollment:  4

Study start: July 2005;  Expected completion: May 2006
Last follow-up: February 2006;  Data entry closure: March 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 Institute 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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria: Normal volunteers, 18 years old or older -

Exclusion Criteria: Pregnant of lactating Diabetic, keloid former, collagen vascular disease Smoker Body Mass Index >30kg/m2 Know history of HIV, AIDS, Hepatitis A, B, or C Bleeding disorder, Aspirin, NSAID or anticoagulant user Cancer or treatment for cancer in past 5 years-

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00125086

Jennifer Bookey      (612) 347-6206 

Minnesota
      DaVita Clinical Research, Minneapolis,  Minnesota,  55404,  United States; Recruiting
Harry Alcorn, Pharm.D.  612-347-6206 
David Hom, M.D.,  Principal Investigator

Study chairs or principal investigators

David Hom, M.D.,  Principal Investigator,  University of Minnesota   

More Information

Study ID Numbers:  APG-01-0605; APG-01-0605
Last Updated:  August 1, 2005
Record first received:  July 29, 2005
ClinicalTrials.gov Identifier:  NCT00125086
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-02


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November 28, 2009



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