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Platelets for Acute Wound Healing

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ClinicalTrials.gov Identifier: NCT00125086
Recruitment Status : Completed
First Posted : July 29, 2005
Last Update Posted : September 14, 2005
Sponsor:
Information provided by:
Medtronic

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.

Condition or disease Intervention/treatment Phase
Wounds Device: autologous platelet gel Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Platelets in Acute Wounds: A Punch Biopsy Study (PAWS II)
Study Start Date : July 2005
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Time to 100% wound closure, measured at Days 7, 14, 21, 28, 35

Secondary Outcome Measures :
  1. Measurements of wound depth at each visit
  2. Measurement of residual scarring at 6 months post wounding


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal volunteers
  • 18 years old or older

Exclusion Criteria:

  • Pregnant or lactating
  • Diabetic, keloid former, collagen vascular disease
  • Smoker
  • Body mass index >30kg/m2
  • Known history of HIV/AIDS; Hepatitis A, B, or C
  • Bleeding disorder
  • Aspirin, non-steroidal anti-inflammatory drug (NSAID) or anticoagulant user
  • Cancer, or treatment for cancer, in past 5 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125086


Locations
United States, Minnesota
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Medtronic
Investigators
Principal Investigator: David Hom, M.D. University of Minnesota - Clinical and Translational Science Institute

ClinicalTrials.gov Identifier: NCT00125086     History of Changes
Other Study ID Numbers: APG-01-0605
APG-01-0605
First Posted: July 29, 2005    Key Record Dates
Last Update Posted: September 14, 2005
Last Verified: September 2005

Keywords provided by Medtronic:
wounds
healing
Acute wounds healing by secondary intention

Additional relevant MeSH terms:
Wounds and Injuries