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NCT00199992 Clinical Trial

Platelets in Acute Wounds: A Pilot Study (PAWS)

Wounds Clinical Trial

Official title:
Platelets in Acute Wounds: A Pilot Study (PAWS)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00199992
Other study ID # APG-01-02-05
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated September 12, 2005
Start date January 2005
Est. completion date August 2005

Study information
Verified date September 2005
Source Medtronic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Comparison of wound healing treatments; platelet gel vs. control

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.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date August 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• application of autologous platelet gel

Locations
Country Name City State
United States DaVita Clinical Research Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Medtronic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to complete closure
Secondary pain
Secondary long-term scar appearance
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