Platelets for Acute Wound Healing

Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00125086
• Other study ID #: APG-01-0605
• Secondary ID: APG-01-0605
• Status: Completed
• Phase: N/A
• First received: July 27, 2005
• Last updated: September 12, 2005
• Start date: July 2005
• Est. completion date: February 2006

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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: February 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wounds

Intervention

Device:
• 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 100% wound closure, measured at Days 7, 14, 21, 28, 35
Secondary	Measurements of wound depth at each visit
Secondary	Measurement of residual scarring at 6 months post wounding