Platelets for Acute Wound Healing

This study has been completed.
Sponsor:
Information provided by:
Medtronic
ClinicalTrials.gov Identifier:
NCT00125086
First received: July 27, 2005
Last updated: September 12, 2005
Last verified: September 2005
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Platelets in Acute Wounds: A Punch Biopsy Study (PAWS II)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00125086     History of Changes
Other Study ID Numbers: APG-01-0605, APG-01-0605
Study First Received: July 27, 2005
Last Updated: September 12, 2005
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 14, 2014