Platelet Rich Therapy for Scar Revision
June 12, 2018 updated by: Alex Reivitis, Rejuva Medical Aesthetics
Platelet Rich Therapy for Scar Revision Post Abdominoplasty
This study will evaluate the efficacy of platelet injections for use of scar therapy post abdominoplasty operations.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Platelet therapy is quickly becoming an integral aspect of both medical and cosmetic procedures.
Most notably, Platelet Rich Plasma (PRP) has been used in surgical settings to stimulate healing and promote tissue regeneration.
In the field of cosmetic medicine, PRP has been used topically or as an injection to stimulate collagen production and enhance the efficacy of cosmetic procedures such as fat transfer, hair loss therapies, laser treatments, and microneedling.
Harvested PRP has platelets, fibrin, and white blood cells, which contribute to wound healing, neocollagenesis, and elastogenesis.
Platelet Rich Fibrin (PRF) is the next generation of PRP and contains very high concentrations white blood cells, fibrin and a small amount of mesenchymal stem cells found circulating in our bloodstreams.
Due to a lack of anticoagulant in the tube, PRF becomes a gel after 15-20 minutes of being isolated.
These properties make PRF useful in reconstructive and aesthetic medicine but may also be beneficial for scar therapy in the same way PRP is currently used.The purpose of this study is to evaluate the efficacy of platelet rich plasma vs. platelet rich fibrin for scar therapy in abdominoplasty who are at least one-year post operation.
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ten (10) subjects
- male and female abdominoplasty procedures at least one year ago.
- must be able to provide healthy blood sample
- must be available for the duration of the study and all follow ups (12 months).
Exclusion Criteria:
- Pregnant and breast-feeding patients are not eligible for this study due to unstudied effects of injectables on the growing fetus and/or breast milk.
- patients who have undergone other scar therapies for the same scar.
- chronic health problems that may prevent the investigators from obtaining a viable blood sample,
- topical infection,
- any subjects who intend to have other scar procedures during the timeline of the study (12 months including punch biopsy procedures 3 months post treatment and 6 months post treatment).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: PRP
Platelet Rich Plasma (PRP) injections into one half of the scar will be preformed.
PRP is already considered an effective treatment for scar therapy.This will be randomly assigned by the clinical research coordinator .
|
Platelet Rich Plasma (PRP) has been used in surgical settings to stimulate healing and promote tissue regeneration.
In the field of cosmetic medicine, PRP has been used topically or as an injection to stimulate collagen production and enhance the efficacy of cosmetic procedures such as fat transfer, hair loss therapies, laser treatments, and microneedling.
Harvested PRP has platelets, fibrin, and white blood cells, which contribute to wound healing, neocollagenesis, and elastogenesis
Other Names:
|
|
Experimental: PRF
Platelet Rich Fibrin (PRF) injections will be preformed the other half of the scar that is not treated with PRP.
PRF has not been established as an effective scar treatment.
The PRF will be considered experimental as this study seeks to evaluate if it is more effective than PRP.
|
Platelet Rich Fibrin (PRF) is the next generation of PRP and contains very high concentrations white blood cells, fibrin and a small amount of mesenchymal stem cells found circulating in our bloodstreams.
Due to a lack of anticoagulant in the tube, PRF becomes a gel after 15-20 minutes of being isolated.
These properties make PRF useful in reconstructive and aesthetic medicine but may also be beneficial for scar therapy in the same way PRP is currently used.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Global Aesthetics Improvement Scale (GAIS)
Time Frame: 6 months
|
Blind observer will complete the Global Aesthetics Improvement Scale at 6 months.
The scale is from 1-5, where 1 is greatly improved cosmetic outcome and 5 is worsened cosmetic outcome.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kian Karimi, MD,FACS, Rejuva Medical Aesthetics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2018
Primary Completion (Anticipated)
January 1, 2019
Study Completion (Anticipated)
July 1, 2019
Study Registration Dates
First Submitted
May 8, 2018
First Submitted That Met QC Criteria
June 12, 2018
First Posted (Actual)
June 13, 2018
Study Record Updates
Last Update Posted (Actual)
June 13, 2018
Last Update Submitted That Met QC Criteria
June 12, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRF02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.