Efficacy of Arnica D1 Ointment After Upper Blepharoplasty: a Randomized, Double-blind Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Surgical outcome
研究概览
简要总结
Arnica ointment is currently used in homeopathic preparations for strains and bruises. In the field of plastic surgery, some surgeons advise patients undergoing blepharoplasty to use Arnica in order to prevent postoperative ecchymosis, swelling and pain. Thus far, no decent study evaluated the efficacy of topical Arnica ointment in reducing ecchymosis or surgical outcome after upper blepharoplasty. We hypothesize that application of Arnica ointment postoperatively will reduce the development of ecchymosis and improve outcome.
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
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing primary blepharoplasty
排除标准
- •use of anticoagulants
研究组 & 干预措施
Arnica ointment
干预措施: Arnica (Drug)
Placebo ointment
干预措施: Placebo ointment (Drug)
结局指标
主要结局
Surgical outcome
时间窗: 7 days and 6 weeks postoperatively
Overall judgment of surgical outcome, based on the combined analysis of the amount of ecchymosis, swelling and redness, by an unrelated, uninvolved and "blinded" plastic surgeon.
次要结局
- amount of tissue swelling; redness; pain; postoperative recovery; patient satisfaction(3, 7 and 42 days postoperatively)
研究者
Wynand BWH Melenhorst, MD
MD, PhD
Isala