Platelets for Acute Wound Healing - Full Text View

Sponsored by:	Medtronic
Information provided by:	Medtronic
ClinicalTrials.gov Identifier:	NCT00125086

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
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

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

More Information

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

Keywords provided by Medtronic:

wounds
healing
Acute wounds healing by secondary intention

Study placed in the following topic categories:

Neoplasm Metastasis

ClinicalTrials.gov processed this record on January 16, 2009