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

Gary M. Kiebzak, Ph.D.

Status: Completed

Conditions: Elective Foot and Ankle Surgery.

Treatments: Biological: PRP and PPP

Study type: Interventional

Funder types: Other

Identifiers

NCT01639144

12-024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 515 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective foot and ankle surgery.

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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515 participants in 2 patient groups

Receiving PRP and PPP.

Active Comparator group

Description:

Administration of PRP and PPP to surgical site.

Treatment:

Biological: PRP and PPP

Control

No Intervention group

Description:

Group not receiving autogenous PRP and PPP.