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Completed

NCT Number: NCT00125086

Platelets for Acute Wound Healing

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.

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Key information

Conditions

Wounds Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autologous platelet gel

Device

Primary outcomes

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

Secondary outcomes

  1. Measurements of wound depth at each visit

  2. Measurement of residual scarring at 6 months post wounding

Sponsors and collaborators

Lead sponsor

Medtronic

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2006
First posted
Jul 29, 2005
Registry last updated
Sep 14, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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