Platelet Rich Therapy for Scar Revision
Primary Purpose
Abdominoplasty Scar Revision
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Platelet Rich Fibrin
Platelet Rich Plasma
Sponsored by
About this trial
This is an interventional treatment trial for Abdominoplasty Scar Revision focused on measuring Abdomen, Abdominoplasty, Scar Therapy, Scar
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
PRP
PRF
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Global Aesthetics Improvement Scale (GAIS)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03555357
Brief Title
Platelet Rich Therapy for Scar Revision
Official Title
Platelet Rich Therapy for Scar Revision Post Abdominoplasty
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2018 (Anticipated)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rejuva Medical Aesthetics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the efficacy of platelet injections for use of scar therapy post abdominoplasty operations.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominoplasty Scar Revision
Keywords
Abdomen, Abdominoplasty, Scar Therapy, Scar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will receive both PRP and PRF injections to the scar. One side will be assigned to PRP and the other PRF (randomly assigned by Clinical Research Coordinator).
Masking
ParticipantOutcomes Assessor
Masking Description
The subject will not be aware of which side is treated with PRP vs. PRF. The blind observer will also not be informed which side was treated with PRP vs. PRF.
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRP
Arm Type
Active Comparator
Arm Description
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 .
Arm Title
PRF
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Platelet Rich Fibrin
Other Intervention Name(s)
PRF
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Platelet Rich Plasma
Other Intervention Name(s)
PRP
Intervention Description
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
Primary Outcome Measure Information:
Title
Global Aesthetics Improvement Scale (GAIS)
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alex N Reivitis, BA
Phone
4246442400
Email
alex@rejuvamedical.org
First Name & Middle Initial & Last Name or Official Title & Degree
Helena Rockwell, BS
Phone
4246442400
Email
helena@rejuvamedical.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kian Karimi, MD,FACS
Organizational Affiliation
Rejuva Medical Aesthetics
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Platelet Rich Therapy for Scar Revision
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