Platelet Rich Therapy for Scar Revision Post Abdominoplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 主要终点
- Global Aesthetics Improvement Scale (GAIS)
研究概览
简要总结
This study will evaluate the efficacy of platelet injections for use of scar therapy post abdominoplasty operations.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Platelet Rich Fibrin (Other)
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 .
干预措施: Platelet Rich Plasma (Other)
结局指标
主要结局
Global Aesthetics Improvement Scale (GAIS)
时间窗: 6 months
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.
次要结局
未报告次要终点
研究者
Alex Reivitis
Clinical Research Coordinator
Rejuva Medical Aesthetics