Abdominoplasty Scar Revision Clinical Trial
Official title:
Platelet Rich Therapy for Scar Revision Post Abdominoplasty
NCT number | NCT03555357 |
Other study ID # | PRF02 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2018 |
Est. completion date | July 2019 |
This study will evaluate the efficacy of platelet injections for use of scar therapy post abdominoplasty operations.
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). |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Rejuva Medical Aesthetics |
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 |