Effect of Strontium-90 Brachytherapy Combined With Hyperthermia in the Treatment of Keloid
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Vancouver Scar Scale (VSS) scores
研究概览
简要总结
Keloid patients were randomized into the experimental and control groups. Experimental group: Strontium-90 (Sr-90) brachytherapy followed by hyperthermia. Control group: Sr-90 brachytherapy alone .
详细描述
Sr-90 brachytherapy: 6-7 Gy each time, twice a week for 3 weeks; Hyperthermia: using a heater, 44℃ for 15 min
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
- None
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient was clinically diagnosed with keloid, and the keloid area was clean without rupture and exudation；
- •Body surface keloid thickness: 2~5mm, diameter ≥10mm.
排除标准
- •Women who plan to become pregnant within 3 months or are pregnant or breastfeeding;
- •Patients with cicatricial constitution;
- •Abnormal coagulation function;
- •Patients who have received an adequate dose or course of radiation therapy;
- •People with previous immune system diseases, diabetes and other metabolic diseases.
结局指标
主要结局
Vancouver Scar Scale (VSS) scores
时间窗: once every 3 months for 1 year after the last treatment
Physician evaluation comprised the use of the Vancouver Scar Scale (VSS) to evaluate the pigmentation (0=normal, 1=hypopigmented, 2=hyperpigmented), pliability (0=normal, 1= supple, 2=yielding, 3=firm, 4=banding, 5=contracture), height (0= flat, 1=5 mm), and vascularity (0=normal, 1=pink, 2=pink to red, 3=red, 4=red to purple, 5=purple).
Patient and Observer Scar Assessment Scale (POSAS) scores
时间窗: once every 3 months for 1 year after the last treatment
The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area). All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). The sum of the six items results in a total score of the POSAS observer scale. Categories boxes are added for each item. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location. comparable anatomic location.
次要结局
未报告次要终点
研究者
Feng Wang
Director of nuclear medicine department
Nanjing First Hospital, Nanjing Medical University