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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
Rejuva Medical Aesthetics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominoplasty Scar Revision focused on measuring Abdomen, Abdominoplasty, Scar Therapy, Scar

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 8, 2018
    Last Updated
    June 12, 2018
    Sponsor
    Rejuva Medical Aesthetics
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    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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