Platelets for Acute Wound Healing - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 27, 2005

Last Updated Date

September 12, 2005

Start Date ^†

July 2005

Current Primary Outcome Measures ^†

Time to 100% wound closure, measured at Days 7, 14, 21, 28, 35

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00125086 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Measurements of wound depth at each visit
Measurement of residual scarring at 6 months post wounding

Original Secondary Outcome Measures ^†

Measurements of wound depth at each visit. Measurement of residual scarring at 6 months post wounding.

Descriptive Information

Brief Title ^†

Platelets for Acute Wound Healing

Official Title ^†

Platelets in Acute Wounds: A Punch Biopsy Study (PAWS II)

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Wounds

Intervention ^†

Device: autologous platelet gel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

February 2006

Primary Completion Date

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00125086

Responsible Party

Secondary IDs ^††

APG-01-0605

Study Sponsor ^†

Medtronic

Collaborators ^††

Investigators ^†

Principal Investigator:

David Hom, M.D.

University of Minnesota

Information Provided By

Medtronic

Verification Date

September 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.