Platelets for Acute Wound Healing
Primary Purpose
Wounds
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
autologous platelet gel
Sponsored by
About this trial
This is an interventional treatment trial for Wounds focused on measuring wounds, healing, Acute wounds healing by secondary intention
Eligibility 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
Sites / Locations
- DaVita Clinical Research
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00125086
Brief Title
Platelets for Acute Wound Healing
Official Title
Platelets in Acute Wounds: A Punch Biopsy Study (PAWS II)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Medtronic
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds
Keywords
wounds, healing, Acute wounds healing by secondary intention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
4 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
autologous platelet gel
Primary Outcome Measure Information:
Title
Time to 100% wound closure, measured at Days 7, 14, 21, 28, 35
Secondary Outcome Measure Information:
Title
Measurements of wound depth at each visit
Title
Measurement of residual scarring at 6 months post wounding
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hom, M.D.
Organizational Affiliation
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
Learn more about this trial
Platelets for Acute Wound Healing
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