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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gary M. Kiebzak, Ph.D., UHZ Sports Medicine Institute
ClinicalTrials.gov Identifier:
NCT01639144
First received: July 10, 2012
Last updated: May 21, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention
Elective Foot and Ankle Surgery.
Biological: PRP and PPP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by UHZ Sports Medicine Institute:

Primary Outcome Measures:
  • Postoperative Infection and Delayed Wound Healing. [ Time Frame: Infection: 30 days after surgery. Delayed wound healing: 60 days. ] [ Designated as safety issue: No ]
    Postoperative deep incisional surgical site infection and delayed wound healing (lack of primary healing of skin edges typically with wound secretion).


Enrollment: 515
Study Start Date: July 2012
Study Completion Date: March 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective foot and ankle surgery.

Exclusion Criteria:

  • Younger than 18 years, older than 80 years of age.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01639144

Locations
United States, Florida
UHZ Sports Medicine Institute
Coral Gables, Florida, United States, 33146
Sponsors and Collaborators
Gary M. Kiebzak, Ph.D.
Investigators
Study Director: Gary M Kiebzak, Ph.D. Center for Research & Grants
  More Information

No publications provided

Responsible Party: Gary M. Kiebzak, Ph.D., Clinical Research Administrator, UHZ Sports Medicine Institute
ClinicalTrials.gov Identifier: NCT01639144     History of Changes
Other Study ID Numbers: 12-024
Study First Received: July 10, 2012
Results First Received: April 6, 2015
Last Updated: May 21, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by UHZ Sports Medicine Institute:
Infection
delayed wound healing
platelet-rich plasma

ClinicalTrials.gov processed this record on September 03, 2015