Prospective Evaluation of the Use of High-dose-rate Brachytherapy for the Treatment of Recalcitrant Keloids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Recurrence
研究概览
简要总结
This prospective study evaluates the outcome of surgical excision with adjuvant high-dose-rate brachytherapy for the treatment of recalcitrant keloids. Main outcomes are recurrence rate, scar quality and physical complaints.
详细描述
This prospective evaluation describes the outcome of surgical excision with adjuvant high-dose-rate brachytherapy for the treatment of recalcitrant keloids in a large mixed Fitzpatrick skin type patient population. After intralesional excision, a unique low dose radiation scheme of 2x6Gray (Gy) was administered in 2 fractions: the first within 4 hours, the second within 24 hours. Keloids were evaluated pre- and postoperative (1 week, 3, 6, 12 months, 5years). Scars were measured and recurrence was judged. An evaluation of the outcome of the scars was obtained using the Patient and Observer Scar Assessment Scale. Statistical analyses were conducted using SPSS version 20.0 (SPSS, Inc, Chicago, III)
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Keloid defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion. Keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (>1yr)
- •the keloid had been proven insensitive to at least one other treatment
- •patients had to be older than 10 years of age.
排除标准
- •keloids not suitable for excision with primary closure due to its size or anatomical location
- •pregnancy or diabetes
结局指标
主要结局
Recurrence
时间窗: At a minimum of one year post surgery
Recurrence was defined as a growing, pruritic, nodular scar as described by Cosman and Wolff(1)
次要结局
- Scar Quality(Pre- and postoperative)
研究者
Michiel van Leeuwen
MD
Amsterdam UMC, location VUmc