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

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ClinicalTrials.gov Identifier: NCT01639144
Recruitment Status : Completed
First Posted : July 12, 2012
Results First Posted : May 22, 2015
Last Update Posted : May 22, 2015
Sponsor:
Information provided by (Responsible Party):
Gary M. Kiebzak, Ph.D., UHZ Sports Medicine Institute

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Elective Foot and Ankle Surgery. Biological: PRP and PPP Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 515 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : July 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : March 2015

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639144


Locations
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United States, Florida
UHZ Sports Medicine Institute
Coral Gables, Florida, United States, 33146
Sponsors and Collaborators
Gary M. Kiebzak, Ph.D.
Investigators
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Study Director: Gary M Kiebzak, Ph.D. Center for Research & Grants
More Information
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Responsible Party: Gary M. Kiebzak, Ph.D., Clinical Research Administrator, UHZ Sports Medicine Institute
ClinicalTrials.gov Identifier: NCT01639144    
Other Study ID Numbers: 12-024
First Posted: July 12, 2012    Key Record Dates
Results First Posted: May 22, 2015
Last Update Posted: May 22, 2015
Last Verified: May 2015
Keywords provided by Gary M. Kiebzak, Ph.D., UHZ Sports Medicine Institute:
Infection
delayed wound healing
platelet-rich plasma
Additional relevant MeSH terms:
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Infections