Use of Platelet-Rich Plasma (PRP) and Platelet-Poor Plasma (PPP) to Prevent Infection and Delayed Wound Healing

NCT ID: NCT01639144

Last Updated: 2015-05-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

515 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-03-31

Brief Summary

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The purpose of this study is to see if applying PRP and PPP to surgical sites and the closing incision helps prevent infection and slow wound healing.

Detailed Description

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This will be a prospective, randomized study with patients blinded to either receiving platelet-rich plasma (PRP) and platelet-poor plasma (PPP) treatment or no treatment. We hypothesize that the antimicrobial properties of PRP and barrier properties of PPP (acting like a tissue sealant) will serve to inhibit deep incisional surgical site infection and help prevent delayed wound healing within 60 days of surgery. Thus, the incidence of infection and delayed wound healing will be lower in patients receiving PRP and PPP compared to patients who do not receive PRP and PPP. However, due to clinical equipoise, we do not know for certain that PRP and PPP is truly effective. The cost of preparing PRP and PPP is substantial, and involves a blood draw that would not otherwise be done. Thus, it is important to know if this treatment is effective or not.

Conditions

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Elective Foot and Ankle Surgery.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Receiving PRP and PPP.

Administration of PRP and PPP to surgical site.

Group Type ACTIVE_COMPARATOR

PRP and PPP

Intervention Type BIOLOGICAL

Autogenous PRP and PPP

Control

Group not receiving autogenous PRP and PPP.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PRP and PPP

Autogenous PRP and PPP

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Elective foot and ankle surgery.

Exclusion Criteria

* Younger than 18 years, older than 80 years of age.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gary M. Kiebzak, Ph.D.

OTHER

Sponsor Role lead

Responsible Party

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Gary M. Kiebzak, Ph.D.

Clinical Research Administrator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gary M Kiebzak, Ph.D.

Role: STUDY_DIRECTOR

Center for Research & Grants

Locations

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UHZ Sports Medicine Institute

Coral Gables, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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12-024

Identifier Type: -

Identifier Source: org_study_id

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