NCT00958425撤回3 期
Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty: a Phase III Double-blinded, Single-centred, Randomized Controlled Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Rasch analysis-modified Objective Scar Assessment Score (OSAS) value
研究概览
简要总结
The purpose of this study is to determine the efficacy of hyaluronic acid gel injections compared to saline injections in improving scar quality in patients undergoing breast reduction surgery. Hyaluronic acid has been implicated in scarless fetal healing, and the investigators therefore hypothesize that injections of hyaluronic acid gel into breast reduction incisions will improve their appearance compared to injections of saline.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •adequate organ function (BUN < 4.0 mmol/L; serum creatinine < 120 micromol/L; Hgb > 100 g/L; WBC > 4,000/mm3 and < 12,000/mm3; platelets > 100,000/mm3)
- •age 18 years or older, with a minimum life expectancy of 2 years
- •current non-smoker
- •American Society of Anaesthesiology score of 1 or 2
- •ability to provide informed consent
排除标准
- •previous history of breast surgery; known allergy to polyglactin, poliglecaprone, or injectable hyaluronic acid gel (Restylane or Prevelle)
- •history of current or recent (<2 months) immunosuppression
- •documented hypersensitivity to streptococcal products
- •acute or chronic skin diseases such as folliculitis or psoriasis
- •history of bleeding dyscrasia or active anticoagulation (INR>2.0)
- •pregnancy or active breast-feeding
- •any additional surgical procedures performed in the same surgical session in the same anatomical region
- •personal or family history of susceptibility to keloid or hypertrophic scar formation
- •Fitzpatrick skin type 5 or 6.
结局指标
主要结局
Rasch analysis-modified Objective Scar Assessment Score (OSAS) value
时间窗: 12 months post-operatively
次要结局
未报告次要终点
研究者
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