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

Not Applicable

Completed

• Conditions: Elective Foot and Ankle Surgery.
• Interventions: Biological: PRP and PPP

• Registration Number: NCT01639144
• Lead Sponsor: Gary M. Kiebzak, Ph.D.

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.

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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-10
• Study First Submitted QC: 2012-07-11
• Study First Posted: 2012-07-12
• Primary Completion: 2015-01
• Study Completion: 2015-03
• Results First Submitted: 2015-04-06
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-21
• Last Update Submitted: 2015-05-21
• Results First Posted: 2015-05-22
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 515

Inclusion Criteria

• Elective foot and ankle surgery.

Exclusion Criteria

• Younger than 18 years, older than 80 years of age.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Receiving PRP and PPP.	PRP and PPP	Administration of PRP and PPP to surgical site.

Primary Outcome Measures

Name	Time	Method
Postoperative Infection and Delayed Wound Healing.	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).

Trial Locations

Locations (1)

UHZ Sports Medicine Institute; 🇺🇸 Coral Gables, Florida, United States