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PRP Injection for Hypertrophic Scar
Phase 2
Waitlist Available
Led By Galen Perdikis, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hypertrophic burn scar present on trunk or abdomen
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 1 year
Awards & highlights
Study Summary
This trial is testing whether a person's own blood platelets can help improve the appearance and feel of their hypertrophic burn scars.
Eligible Conditions
- Hypertrophic Scars
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Scar Assessment: POSAS at 2 Months
Scar Assessment: VSS at 2 Months
Secondary outcome measures
Change in Scar Assessment: VSS 1 year
Change in Scar assessment: POSAS 1 year
Trial Design
2Treatment groups
Experimental Treatment
Group I: PRP injection right halfExperimental Treatment2 Interventions
The scar to be treated will first be wiped with an alcohol swab, then measured and marked out with a marking pen such that the entirety of the scar will fit into a symmetric ellipse that is drawn, and the ellipse is filled entirely with the scar tissue. A ruler will be used to measure the scar in its greatest horizontal span, and the midway point will be marked with a vertical line. A coin flip will determine if the PRP injection (the experimental half) will be on the right half of the scar (as opposed to the left half). The half of the scar that will not receive PRP will be the control half.
After finishing the VSS and POSAS, the area inside the control half of the ellipse will then be subdivided with a marking pen into 1cm x 1cm square boxes, with the plan of injecting 1mL normal saline into each 1 square cm box at 0 months, 1 month, 4 months, and 6 months.
Punch biopsies from each scar will be will be obtained at both six months and one year from enrollment.
Group II: PRP injection left halfExperimental Treatment2 Interventions
The scar to be treated will first be wiped with an alcohol swab, then measured and marked out with a marking pen such that the entirety of the scar will fit into a symmetric ellipse that is drawn, and the ellipse is filled entirely with the scar tissue. A ruler will be used to measure the scar in its greatest horizontal span, and the midway point will be marked with a vertical line. A coin flip will determine if the PRP injection (the experimental half) will be on the right half of the scar (as opposed to the left half). The half of the scar that will not receive PRP will be the control half.
After finishing the VSS and POSAS, the area inside the experimental half of the ellipse will then be subdivided with a marking pen into 1cm x 1cm square boxes, with the plan of injecting 1mL PRP into each 1 square cm box at 0 months, 1 month, 4 months, and 6 months.
Punch biopsies from each scar will be will be obtained at both six months and one year from enrollment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PRP Injection
2007
N/A
~110
Saline Injection
2018
Completed Phase 3
~750
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
672,190 Total Patients Enrolled
Galen Perdikis, MDPrincipal InvestigatorVanderbilt University School of Medicine
1 Previous Clinical Trials
60 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do you have an active enrollment process for this research endeavor?
"Contrary to expectation, the clinical trial listed on clinicialtrials.gov is not currently enrolling patients; it was first posted in September of 2020 and last updated in December 2021. Nevertheless, 93 similar trials are still recruiting participants at this time."
Answered by AI
Is it permissible to join the clinical trial?
"For this research project, a total of 40 individuals aged 18-70 with hypertrophy will be admitted. Furthermore, the patient must also have an hypertrophic burn scar on their abdomen or trunk area."
Answered by AI
Has platelet-rich plasma injection been granted authorization by the FDA?
"Due to the lack of evidence regarding its efficacy, PRP injection was given a rating of 2 for safety. Nevertheless, there is data indicating that it can be harmless when utilized in clinical trials."
Answered by AI
Is this medical trial open to participants younger than 20 years old?
"This medical trial only accepts participants between 18 and 70 years of age. There are several studies available for those under 18, while 74 trials are geared towards patients over 65."
Answered by AI
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