Platelet Rich Therapy for Scar Revision

NCT03555357 | Unknown

• 1 other identifier: PRF02
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Abdominoplasty Scar Revision

Keywords

Abdomen; Abdominoplasty; Scar Therapy; Scar

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (2)

PRP

ACTIVE COMPARATOR

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 .

Other: Platelet Rich Plasma

PRF

EXPERIMENTAL

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.

Other: Platelet Rich Fibrin

Interventions

Platelet Rich Fibrin 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.

Also known as: PRF

PRF

Platelet Rich Plasma 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

Also known as: PRP

PRP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rejuva Medical Aesthetics: lead

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kian Karimi, MD,FACS

  Rejuva Medical Aesthetics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex N Reivitis, BA

CONTACT

4246442400; alex@rejuvamedical.org

Helena Rockwell, BS

CONTACT

4246442400; helena@rejuvamedical.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Coordinator

Model Details: 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).

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 13, 2018
• Study Start: July 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: July 1, 2019
• Last Updated: June 13, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share