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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

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City:   Coral Gables
State:   Florida
Zip Code:   33146
Conditions:   Elective Foot and Ankle Surgery.
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.
Study Summary:   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.
Criteria:   Inclusion Criteria: - Elective foot and ankle surgery. Exclusion Criteria: - Younger than 18 years, older than 80 years of age.
NCT ID:   NCT01639144
Primary Contact:   Principal Investigator
Thomas P. SanGiovanni, M.D.
UHZ Sports Medicine Institute

Gary M. Kiebzak, Ph.D.
Phone: 786-268-6228
Email: garyk@baptisthealth.net
Backup Contact:   N/A
Location Contact:   Coral Gables, Florida 33146
United States

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

Site Status: Recruiting

Data Source:   ClinicalTrials.gov
Date Processed:   May 19, 2013
Modifications to this listing:   Only selected fields are shown, please use the link below to view all information about this clinical trial.
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