Skin Reactions Related to Thoracic Implantable Chamber Dressings
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Measuring the incidence of skin reactions associated with thoracic implantable chamber dressings
研究概览
简要总结
Prospective, multicenter cohort of 500 patients newly treated with systemic chemotherapy with CCI. The main objective of this study is to measure the incidence of skin reactions related to thoracic implantable chamber dressings.
详细描述
The Implantable Catheter Chamber (ICC) has been in use since the 1980s. It enables the administration of nutrition and/or venotoxic and cytotoxic treatment without altering the patient's venous capital. In oncology, CCIs account for over 90% of central venous accesses used in France, i.e. some 160,000 installations per year.
However, the use of this type of central line can also expose patients to the risk of complications such as infection, obstruction and extravasation, which, given the high stakes for patients, have led to the prioritization of work on these subjects.
To date, studies have focused almost exclusively on infectious risks, which are the most frequent and have the greatest impact on patients. This work has led to improvements in professional practices, such as covering with a semi-permeable film to control the appearance of infectious signs.
Other problems have emerged, such as skin reactions linked to semi-permeable films. These are defined by the appearance of one or more of the following criteria:
- Persistent redness at the dressing site;
- Itching;
- Dermabrasion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age
- •New chemotherapy patients (1st line of treatment only)
- •Thoracic PAC
排除标准
- •PICC Line and femoral PAC;
- •Patients undergoing treatment with bi-specific antibodies (e.g. tebentafusp);
- •Disunion requiring treatment
- •Patients treated for hematological cancer;
- •Persons deprived of their liberty or under guardianship (including curatorship);
- •Adults under court protection;
- •Inability to participate in the study for geographical, social or psychological reasons.
- •No inclusion of persons covered by articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the French Public Health Code (e.g. minors, protected adults, etc.).
- •Opposition to data use
结局指标
主要结局
Measuring the incidence of skin reactions associated with thoracic implantable chamber dressings
时间窗: through study completion, an average of 18 months
Appearance of itching and/or erythema (defined as diffuse or localized congestive redness of the skin) at the dressing site
次要结局
- Identify risk factors for skin reactions to dressings(through study completion, an average of 18 months)
- Estimate the consequences of these reactions in terms of therapeutic management (implementation of a specific skin treatment, postponement or cancellation of chemotherapy), complications (catheter infection), patient comfort and satisfaction.(through study completion, an average of 18 months)