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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by UHZ Sports Medicine Institute
Sponsor:
Information provided by (Responsible Party):
Thomas P San Giovanni, M.D., UHZ Sports Medicine Institute
ClinicalTrials.gov Identifier:
NCT01639144
First received: July 10, 2012
Last updated: July 11, 2012
Last verified: July 2012
  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: Single Group 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 [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Postoperative deep incisional surgical site infection.


Secondary Outcome Measures:
  • Delayed wound healing [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    No observation of primary healing of skin edges.


Estimated Enrollment: 2000
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (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 30 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639144

Contacts
Contact: Gary M. Kiebzak, Ph.D. 786-268-6228 garyk@baptisthealth.net

Locations
United States, Florida
UHZ Sports Medicine Institute Recruiting
Coral Gables, Florida, United States, 33146
Contact: Gary M. Kiebzak, Ph.D.    786-268-6228    garyk@baptisthealth.net   
Principal Investigator: Thomas P. SanGiovanni, M.D.         
Sponsors and Collaborators
UHZ Sports Medicine Institute
Investigators
Principal Investigator: Thomas P. SanGiovanni, M.D. UHZ Sports Medicine Institute
  More Information

No publications provided

Responsible Party: Thomas P San Giovanni, M.D., PI, UHZ Sports Medicine Institute
ClinicalTrials.gov Identifier: NCT01639144     History of Changes
Other Study ID Numbers: 12-024
Study First Received: July 10, 2012
Last Updated: July 11, 2012
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 August 20, 2014