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Platelets in Acute Wounds: A Pilot Study (PAWS)

This study has been completed.

Sponsored by: Medtronic
Information provided by: Medtronic
ClinicalTrials.gov Identifier: NCT00199992
  Purpose

Comparison of wound healing treatments; platelet gel vs. control


Condition Intervention
Wounds
Procedure: application of autologous platelet gel

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Platelets in Acute Wounds: A Pilot Study (PAWS)

Further study details as provided by Medtronic:

Primary Outcome Measures:
  • Time to complete closure

Secondary Outcome Measures:
  • pain
  • long-term scar appearance

Estimated Enrollment:   8
Study Start Date:   January 2005
Estimated Study Completion Date:   August 2005

Detailed Description:

Comparison of autologous platelet gel to a control treatment in acute wounds, specifically punch biopsy wounds. Eight patients included in this pilot/feasibility study. Wound healing evaluated over 6 months for wound closure and long term outcome.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

Healthy non-smokers, >18 years of age, BMI<30 -

Exclusion Criteria:

Smokers, obese, keloid formers, bleeding disorders, medications -

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199992

Locations
United States, Minnesota
DaVita Clinical Research    
      Minneapolis, Minnesota, United States, 55404

Sponsors and Collaborators
Medtronic

Investigators
Principal Investigator:     David HOM, M.D.     Hennepin County Medical Center/ University of Minnesota    
  More Information

Study ID Numbers:   APG-01-02-05
First Received:   September 12, 2005
Last Updated:   September 12, 2005
ClinicalTrials.gov Identifier:   NCT00199992
Health Authority:   United States: Institutional Review Board

Keywords provided by Medtronic:
acute wounds  
wounds  
platelets  
platelet gel  

ClinicalTrials.gov processed this record on September 05, 2008




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