Platelets for Acute Wound Healing

Not Applicable

Completed

• Conditions: Wounds

• Registration Number: NCT00125086
• Lead Sponsor: Medtronic

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 Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-07-27
• Study First Submitted QC: 2005-07-28
• Study First Posted: 2005-07-29
• Status Verified: 2005-09
• Last Update Submitted: 2005-09-12
• Last Update Posted: 2005-09-14
• Study Completion: 2006-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

DaVita Clinical Research; 🇺🇸 Minneapolis, Minnesota, United States