Platelets in Acute Wounds: A Pilot Study (PAWS)
Primary Purpose
Wounds
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
application of autologous platelet gel
Sponsored by
About this trial
This is an interventional treatment trial for Wounds focused on measuring acute wounds, wounds, platelets, platelet gel
Eligibility Criteria
Inclusion Criteria: Healthy non-smokers, >18 years of age, BMI<30 - Exclusion Criteria: Smokers, obese, keloid formers, bleeding disorders, medications -
Sites / Locations
- DaVita Clinical Research
Outcomes
Primary Outcome Measures
Time to complete closure
Secondary Outcome Measures
pain
long-term scar appearance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00199992
Brief Title
Platelets in Acute Wounds: A Pilot Study (PAWS)
Official Title
Platelets in Acute Wounds: A Pilot Study (PAWS)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Medtronic
4. Oversight
5. Study Description
Brief Summary
Comparison of wound healing treatments; platelet gel vs. control
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds
Keywords
acute wounds, wounds, platelets, platelet gel
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
application of autologous platelet gel
Primary Outcome Measure Information:
Title
Time to complete closure
Secondary Outcome Measure Information:
Title
pain
Title
long-term scar appearance
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy non-smokers, >18 years of age, BMI<30 -
Exclusion Criteria:
Smokers, obese, keloid formers, bleeding disorders, medications -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David HOM, M.D.
Organizational Affiliation
Hennepin County Medical Center/ University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
DaVita Clinical Research
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17519207
Citation
Hom DB, Linzie BM, Huang TC. The healing effects of autologous platelet gel on acute human skin wounds. Arch Facial Plast Surg. 2007 May-Jun;9(3):174-83. doi: 10.1001/archfaci.9.3.174.
Results Reference
derived
Learn more about this trial
Platelets in Acute Wounds: A Pilot Study (PAWS)
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