Retrospective Observational Study on the Use of Advanced Bacterial-binding Dressings (DACC-coated Hydrogel Dressings) in Radiodermatitis in Women Undergoing Radiotherapy for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Evaluation of clinical effectiveness of the advanced DACC-coated hydrogel dressing
研究概览
简要总结
the study aimed to evaluate the clinical effectiveness, safety and tolerability of a DACC-coated hydrogel advanced dressing for the treatment of radiodermatitis in patients undergoing radiotherapy for breast cancer.
详细描述
The planned assessments include recording RTOG and NRS scores at time points T0 (starting treatment), T1, and T2 (end of treatment), documenting the time to complete re-epithelialization, any interruption of radiotherapy treatment, and collecting organizational and economic data for HTA and SWOT analyses.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex
- •Age ≥18 years
- •Histologically confirmed diagnosis of breast cancer, undergoing adjuvant radiotherapy after surgery and/or chemotherapy.
- •Onset of grade 2-3 radiodermatitis according to the RTOG scale, mainly located in the inframammary region, with or without axillary or supraclavicular extension.
- •Patients treated with a DACC-coated hydrogel device following a radiodermatitis diagnosis, between January 2023 and October
- •Treated on an outpatient basis with an advanced dressing protocol including:
- •Cleansing with 0.05% sodium hypochlorite solution
- •Application of DACC-coated hydrogel dressing, replaced every 2-3 days.
- •Complete clinical data available in outpatient records, including NRS and RTOG.
排除标准
- •Grade 0 radiodermatitis (absence of skin toxicity)
- •Patients with incomplete clinical data or insufficient documentation for the purposes of retrospective analysis
- •Lack of availability of minimum clinical follow-up until complete re-epithelialization
研究组 & 干预措施
Female patients undergoing adjuvant radiotherapy affected by radiodermatitis for breast cancer
Female patients treated with a DACC-coated hydrogel device following the diagnosis of grade 2-3 radiodermatitis according to the RTOG scale mainly localized in the inframammary region, with or without axillary or supraclavicular extension.
Outpatient treatment with an advanced dressing protocol including: cleansing with 0.05% sodium hypochlorite solution, application of DACC-coated hydrogel dressing with replacement every 2-3 days.
结局指标
主要结局
Evaluation of clinical effectiveness of the advanced DACC-coated hydrogel dressing
时间窗: From enrollment to the end of treatment at T2 (clinical resolution/complete re-epithelialization within 20 days from the start of treatment (T0).
Evaluate the clinical effectiveness of the advanced DACC-coated hydrogel dressing used in the management of severe radiodermatitis in patients undergoing radiotherapy for breast cancer; effectiveness will be measured by assessing the reduction in pain using the NRS at the beginning and end of the treatment (from T0 to T2).
次要结局
未报告次要终点