Use of Platelet-Rich Plasma (PRP) and Platelet-Poor Plasma (PPP) to Prevent Infection and Delayed Wound Healing
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 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|
- 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).
|Study Start Date:||July 2012|
|Study Completion Date:||March 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01639144
|United States, Florida|
|UHZ Sports Medicine Institute|
|Coral Gables, Florida, United States, 33146|
|Study Director:||Gary M Kiebzak, Ph.D.||Center for Research & Grants|