Clinical trial NCT03555357: Platelet Rich Therapy for Scar Revision
Official title: Platelet Rich Therapy for Scar Revision Post Abdominoplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominoplasty Scar Revision
Keywords: Abdomen
Abdominoplasty
Scar Therapy
Scar
Lead sponsor: Rejuva Medical Aesthetics
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Global Aesthetics Improvement Scale (GAIS)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rejuva Medical Aesthetics
name: Kian Karimi, MD,FACS
role: PRINCIPAL_INVESTIGATOR
References: