Platelets for Acute Wound Healing

NCT ID: NCT00125086

Last Updated: 2005-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-02-28

Brief Summary

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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

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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.

Conditions

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Wounds

Keywords

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wounds healing Acute wounds healing by secondary intention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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autologous platelet gel

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medtronic

INDUSTRY

Sponsor Role lead

Principal Investigators

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David Hom, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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DaVita Clinical Research

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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APG-01-0605

Identifier Type: -

Identifier Source: secondary_id

APG-01-0605

Identifier Type: -

Identifier Source: org_study_id