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

May 21, 2015 updated by: Gary M. Kiebzak, Ph.D.

Use of Platelet-Rich Plasma (PRP) and Platelet-Poor Plasma (PPP) to Prevent Infection and Delayed Wound Healing After Elective Foot and Ankle Surgery in Healthy Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

515

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33146
        • UHZ Sports Medicine Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective foot and ankle surgery.

Exclusion Criteria:

  • Younger than 18 years, older than 80 years of age.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Receiving PRP and PPP.
Administration of PRP and PPP to surgical site.
Biological: PRP and PPP
Autogenous PRP and PPP
No Intervention: Control
Group not receiving autogenous PRP and PPP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Infection and Delayed Wound Healing.
Time Frame: Infection: 30 days after surgery. Delayed wound healing: 60 days.
Postoperative deep incisional surgical site infection and delayed wound healing (lack of primary healing of skin edges typically with wound secretion).
Infection: 30 days after surgery. Delayed wound healing: 60 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gary M. Kiebzak, Ph.D.

Investigators

  • Study Director: Gary M Kiebzak, Ph.D., Center for Research & Grants

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

July 10, 2012

First Submitted That Met QC Criteria

July 11, 2012

First Posted (Estimate)

July 12, 2012

Study Record Updates

Last Update Posted (Estimate)

May 22, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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