CSMed Wound Dressing on Radiation Dermatitis Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Severity of acute radiation dermatitis
研究概览
简要总结
Investigate the effects of CSMed® for preventing and managing radiation dermatitis in patients with Breast cancer and Head-Neck cancer receiving radiotherapy (≥50 Gy).
详细描述
A prospective study was conducted at the University Hospital Medical Center. The patient received part of the breast/neck skin CSMed® dressing or clinical routine skin care. Record the difference between the part of the skin with dressing and undressed skin for each patient. The severity of acute radiation dermatitis was graded using the RTOG clinical scoring standard. From the beginning of the treatment to 4 weeks after the end of the treatment, skin pain, itching, local fever and tightness, as well as skin healing time were collected every week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving radiation therapy (including undamaged skin and RTOG grade 1 dermatitis).
- •Patients who voluntarily agree to participate in the trial and sign the subject's consent form.
排除标准
- •Patients with dermatitis and burns not caused by radiation therapy.
- •Involuntary patients without signed consent.
- •Those who are allergic to the ingredients in this product.
研究组 & 干预措施
reduce the severity, and enhance healing of radiation dermatitis
The patient received part of the breast/neck skin CSMed® dressing or clinical routine skin care.
干预措施: CSMed Dressing (Drug)
结局指标
主要结局
Severity of acute radiation dermatitis
时间窗: 4 weeks
The severity of radiation dermatitis can be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Grade 1 to 5. NCI CTCAE grade 1 - Faint erythema with dry desquamation. NCI CTCAE grade 2 - Moderate dermatitis is characterized by moderate to brisk erythema and patchy, moist desquamation mostly confined to skin folds and creases. NCI CTCAE grade 3 - There is confluent, moist desquamation in locations other than skin folds. NCI CTCAE grade 4 - This is characterized by skin necrosis or ulceration of full-thickness dermis. NCI CTCAE grade 5 - Death due to dermatitis alone is a very rare event. Radiologists performed radiation therapy according to the needs of clinical diseases. Evaluate and record the case after radiotherapy at 4 weeks, and end the research record.
次要结局
未报告次要终点
研究者
Yueh-Chun Lee
Radiation Oncology Attending Physician
Chung Shan Medical University