Retrospective Cohort Study Comparing a Novel Silicone Gel Wound Dressing vs Standard of Care in the Treatment of Radiation Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 344
- 试验地点
- 1
- 主要终点
- CTCAE for Radiation Dermatitis
研究概览
简要总结
Routinely collected data on radiation-induced skin toxicity from 2010 to 2022 will be retrospectively analyzed. Data will be split into two cohorts: patients that received 1) StrataXRT and 2) standard of care. The incidence of grade ≥ 2 radiation dermatitis, the time to onset of grade ≥ 2 radiation dermatitis, the radiation dose at onset of grade ≥ 2 radiation dermatitis, the incidence of moist desquamation and the number of treatment interruptions will be compared between the cohorts.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Diagnosed with Head and Neck cancer treated with radiation therapy with or without chemotherapy
- •Fractionated courses including at least 30 fractions (treatments)
- •Minimum of 18 completed radiation treatments
- •Radiation dose: > 50 Gy
- •Radiation technique: IMRT
- •Radiation equipment: TrueBeam or Tomotherapy
排除标准
- •Prior radiation to the treatment area
- •Patients with any medical condition such as active connective tissue disorder that predisposes them to an increased risk of potentially severe radiation dermatitis.
- •Patients undergoing SBRT
- •Patients with existing rashes or wounds in the target region or radiation therapy at RT start
- •Patients receiving hypofractionation
- •Patient receiving bolus
研究组 & 干预措施
StrataXRT
干预措施: StrataXRT (Device)
Standard of care
干预措施: Calendula (Drug)
Standard of care
干预措施: Aquaphor (Drug)
结局指标
主要结局
CTCAE for Radiation Dermatitis
时间窗: 5 weeks
Acute radiation dermatitis measured weekly during radiotherapy treatment, using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 score (grade 0 - 5). A higher grade is considered a worse outcome.
次要结局
- Number of patients requiring burn cream application(5 weeks)
- Interval between radiotherapy start and burn cream application(5 weeks)
- Number of patients requiring Mepilex application(5 weeks)
- CTCAE for Hyperpigmentation(5 weeks)
- Interval between radiotherapy start and Mepilex application(5 weeks)