Elective Foot and Ankle Surgery.
Conditions
Keywords
Infection, delayed wound healing, platelet-rich plasma
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.
Interventions
BIOLOGICALPRP and PPP
Autogenous PRP and PPP
Sponsors
Gary M. Kiebzak, Ph.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Elective foot and ankle surgery.
Exclusion criteria
* Younger than 18 years, older than 80 years of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Receiving PRP and PPP. Administration of PRP and PPP to surgical site.
PRP and PPP: Autogenous PRP and PPP | 250 |
| Control Group not receiving autogenous PRP and PPP. | 250 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Met postoperative exclusion criteria | 4 | 3 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Receiving PRP and PPP. | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 68 Participants | 68 Participants | 136 Participants |
| Age, Categorical Between 18 and 65 years | 182 Participants | 182 Participants | 364 Participants |
| Diabetes, rheumatoid arthritis, smoking = risk factors for healing Diabetes, rheumatoid arthritis, smoking | 40 participants | 42 participants | 82 participants |
| Diabetes, rheumatoid arthritis, smoking = risk factors for healing No known risk factors for healing | 210 participants | 208 participants | 418 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 250 Participants | 250 Participants | 500 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 250 Participants | 250 Participants | 500 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 250 participants | 250 participants | 500 participants |
| Sex: Female, Male Female | 161 Participants | 163 Participants | 324 Participants |
| Sex: Female, Male Male | 89 Participants | 87 Participants | 176 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 250 | 0 / 250 |
| serious Total, serious adverse events | 0 / 250 | 0 / 250 |
Outcome results
Primary
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).
Time frame: Infection: 30 days after surgery. Delayed wound healing: 60 days.
Population: Patients have foot and/or ankle surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Receiving PRP and PPP. | Postoperative Infection and Delayed Wound Healing. | Deep surgical site infection | 2 participants |
| Receiving PRP and PPP. | Postoperative Infection and Delayed Wound Healing. | Delayed wound healing | 17 participants |
| Control | Postoperative Infection and Delayed Wound Healing. | Deep surgical site infection | 1 participants |
| Control | Postoperative Infection and Delayed Wound Healing. | Delayed wound healing | 17 participants |