Title

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

    N/A
  • Study Type

    Interventional
  • Study Participants

    515
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.
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 Started
Jul 31
2012
Primary Completion
Jan 31
2015
Study Completion
Mar 31
2015
Results Posted
May 22
2015
Estimate
Last Update
May 22
2015
Estimate

Biological PRP and PPP

Autogenous PRP and PPP

Receiving PRP and PPP. Active Comparator

Administration of PRP and PPP to surgical site.

Control No Intervention

Group not receiving autogenous PRP and PPP.

Criteria

Inclusion Criteria:

Elective foot and ankle surgery.

Exclusion Criteria:

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

Summary

Receiving PRP and PPP.

Control

All Events

Event Type Organ System Event Term

Postoperative Infection and Delayed Wound Healing.

Postoperative deep incisional surgical site infection and delayed wound healing (lack of primary healing of skin edges typically with wound secretion).

Receiving PRP and PPP.

Deep surgical site infection

2.0
participants

Delayed wound healing

17.0
participants

Control

Deep surgical site infection

1.0
participants

Delayed wound healing

17.0
participants

Total

500
Participants

Age, Categorical

Diabetes, rheumatoid arthritis, smoking = risk factors for healing

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Sex: Female, Male

Overall Study

Receiving PRP and PPP.

Control

Drop/Withdrawal Reasons

Receiving PRP and PPP.

Control