Platelet Rich Therapy for Scar Revision

NCT ID: NCT03555357

Last Updated: 2018-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-31

Study Completion Date

2019-07-31

Brief Summary

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This study will evaluate the efficacy of platelet injections for use of scar therapy post abdominoplasty operations.

Detailed Description

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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.

Conditions

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Abdominoplasty Scar Revision

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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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 .

Group Type ACTIVE_COMPARATOR

Platelet Rich Plasma

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Platelet Rich Fibrin

Intervention Type OTHER

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.

Interventions

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Platelet Rich Fibrin

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

Platelet Rich Plasma

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

Intervention Type OTHER

Other Intervention Names

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PRF PRP

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rejuva Medical Aesthetics

OTHER

Sponsor Role lead

Responsible Party

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Alex Reivitis

Clinical Research Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kian Karimi, MD,FACS

Role: PRINCIPAL_INVESTIGATOR

Rejuva Medical Aesthetics

Central Contacts

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Alex N Reivitis, BA

Role: CONTACT

4246442400

Helena Rockwell, BS

Role: CONTACT

4246442400

Other Identifiers

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PRF02

Identifier Type: -

Identifier Source: org_study_id

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