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Platelets for Acute Wound Healing

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00125086
First Posted: July 29, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medtronic
  Purpose
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
Wounds Device: autologous platelet gel

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Platelets in Acute Wounds: A Punch Biopsy Study (PAWS II)

Resource links provided by NLM:


Further study details as provided by Medtronic:

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

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

Estimated Enrollment: 4
Study Start Date: July 2005
Estimated Study Completion Date: February 2006
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00125086     History of Changes
Other Study ID Numbers: APG-01-0605
First Submitted: July 27, 2005
First Posted: July 29, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

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

Additional relevant MeSH terms:
Wounds and Injuries