View Clinical Trial (Medical Research Study)
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
| City: |
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Coral Gables |
| State: |
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Florida |
| Zip Code: |
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33146 |
| Conditions: |
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Elective Foot and Ankle Surgery. |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- Elective foot and ankle surgery.
Exclusion Criteria:
- Younger than 18 years, older than 80 years of age.
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| NCT ID: |
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NCT01639144 |
| Primary Contact: |
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Principal Investigator Thomas P. SanGiovanni, M.D. UHZ Sports Medicine Institute
Gary M. Kiebzak, Ph.D. Phone: 786-268-6228 Email: garyk@baptisthealth.net
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| Backup Contact: |
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N/A |
| Location Contact: |
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Coral Gables, Florida 33146 United States
Gary M. Kiebzak, Ph.D. Phone: 786-268-6228 Email: garyk@baptisthealth.net
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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