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: 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|
- Postoperative infection [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]Postoperative deep incisional surgical site infection.
- Delayed wound healing [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]No observation of primary healing of skin edges.
|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)|
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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01639144
|Contact: Gary M. Kiebzak, Ph.D.||email@example.com|
|United States, Florida|
|UHZ Sports Medicine Institute||Recruiting|
|Coral Gables, Florida, United States, 33146|
|Contact: Gary M. Kiebzak, Ph.D. 786-268-6228 firstname.lastname@example.org|
|Principal Investigator: Thomas P. SanGiovanni, M.D.|
|Principal Investigator:||Thomas P. SanGiovanni, M.D.||UHZ Sports Medicine Institute|