Trial Outcomes & Findings for Use of Platelet-Rich Plasma (PRP) and Platelet-Poor Plasma (PPP) to Prevent Infection and Delayed Wound Healing (NCT NCT01639144)
NCT ID: NCT01639144
Last Updated: 2015-05-22
Results Overview
Postoperative deep incisional surgical site infection and delayed wound healing (lack of primary healing of skin edges typically with wound secretion).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
515 participants
Primary outcome timeframe
Infection: 30 days after surgery. Delayed wound healing: 60 days.
Results posted on
2015-05-22
Participant Flow
Participant milestones
| Measure |
Receiving PRP and PPP.
Administration of PRP and PPP to surgical site.
|
Control
Group not receiving autogenous PRP and PPP.
|
|---|---|---|
|
Overall Study
STARTED
|
260
|
255
|
|
Overall Study
COMPLETED
|
250
|
250
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
Receiving PRP and PPP.
Administration of PRP and PPP to surgical site.
|
Control
Group not receiving autogenous PRP and PPP.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Met postoperative exclusion criteria
|
4
|
3
|
Baseline Characteristics
Use of Platelet-Rich Plasma (PRP) and Platelet-Poor Plasma (PPP) to Prevent Infection and Delayed Wound Healing
Baseline characteristics by cohort
| Measure |
Receiving PRP and PPP.
n=250 Participants
Administration of PRP and PPP to surgical site.
PRP and PPP: Autogenous PRP and PPP
|
Control
n=250 Participants
Group not receiving autogenous PRP and PPP.
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
182 Participants
n=5 Participants
|
182 Participants
n=7 Participants
|
364 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
68 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
161 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
324 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
250 Participants
n=5 Participants
|
250 Participants
n=7 Participants
|
500 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
250 Participants
n=5 Participants
|
250 Participants
n=7 Participants
|
500 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
250 participants
n=5 Participants
|
250 participants
n=7 Participants
|
500 participants
n=5 Participants
|
|
Diabetes, rheumatoid arthritis, smoking = risk factors for healing
Diabetes, rheumatoid arthritis, smoking
|
40 participants
n=5 Participants
|
42 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Diabetes, rheumatoid arthritis, smoking = risk factors for healing
No known risk factors for healing
|
210 participants
n=5 Participants
|
208 participants
n=7 Participants
|
418 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Infection: 30 days after surgery. Delayed wound healing: 60 days.Population: Patients have foot and/or ankle surgery.
Postoperative deep incisional surgical site infection and delayed wound healing (lack of primary healing of skin edges typically with wound secretion).
Outcome measures
| Measure |
Receiving PRP and PPP.
n=250 Participants
Administration of PRP and PPP to surgical site.
|
Control
n=250 Participants
Group not receiving autogenous PRP and PPP.
|
|---|---|---|
|
Postoperative Infection and Delayed Wound Healing.
Deep surgical site infection
|
2 participants
|
1 participants
|
|
Postoperative Infection and Delayed Wound Healing.
Delayed wound healing
|
17 participants
|
17 participants
|
Adverse Events
Receiving PRP and PPP.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Gary M. Kiebzak, Ph.D., Co-investigator and Clinical Research Administrator
Center for Research & Grants, Baptist Health South Florida
Phone: 786-268-6224
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place