Platelet Rich Therapy for Scar Revision

Abdominoplasty Scar Revision Clinical Trial

Official title:

Platelet Rich Therapy for Scar Revision Post Abdominoplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03555357
• Other study ID #: PRF02
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2018
• Est. completion date: July 2019

Study information

• Verified date: May 2018
• Source: Rejuva Medical Aesthetics
• Contact: Alex N Reivitis, BA
• Phone: 4246442400
• Email: alex[@]rejuvamedical.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: July 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Abdominoplasty Scar Revision

Intervention

Other:
• 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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rejuva Medical Aesthetics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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