Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Incidence of local infection
研究概览
简要总结
This study aims to demonstrate the safety of intracutaneous needles in pediatric cancer patients. For this, a two-year retrospective study will be carried out to determine the incidence of adverse effects related to acupuncture and the use of intracutaneous needles in the patient in active treatment and survivor.
详细描述
Retrospective study of review of medical records. It is a single-center, descriptive, observational study. There are no comparison or control groups. No type of patient selection (randomization or blinding) will be performed.
The medical records of patients treated at the Integrative Pediatric Oncology Unit from September 2019 to September 2021 who have received acupuncture treatment (disposable intracutaneous needles) will be reviewed.
The number of treatments applied, the localization of the treatment, the average number of sessions per patient, and the total number of intracutaneous needles and punctured needles from September 2019 to September 2021. Likewise, the blood cultures and other adverse effects will be reviewed up to 72 hours after the removal of the needles and the intracutaneous needles (Seirin New Pyonex Press Tack®).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Day 至 34 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric oncology patients from September 2019 to September 2021 who have received treatment with acupuncture.
- •Pediatric oncology patients from September 2019 to September 2021 who have received treatment with intracutaneous needles (Pyonex).
排除标准
- •Pediatric oncology patients who have not received treatment with acupuncture or intracutaneous needles.
结局指标
主要结局
Incidence of local infection
时间窗: From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle)
To calculate the incidence of local infection in pediatric oncology patients during the days that the intracutaneous Seirin New Pyonex Press Tack® needles have been inserted. The result can be "yes" or "no".
Incidence of bacteremia
时间窗: 72 hours after removal intracutaneous needle
Analyze the incidence of positive blood cultures for gram-positive cocci up to 72 hours after removal of the intracutaneous Seirin New Pyonex Press Tack® needles. The result can be "yes" or "no".
次要结局
- Incidence of bruising or bleeding(From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle))
- Incidence of sepsis(From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle))
- Number of acupuncture needles(The day of the application of the acupuncture treatment)
- Incidence of skin erosion(From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle))
- Number of intracutaneous needles(The day of the application of the acupuncture treatment)
- Type of acupuncture treatment(The day of the application of the acupuncture treatment)
- Degree of neutropenia(The day of the application of the acupuncture treatment in patients in oncological treatment. In survivors, the last available, up 365 days)
- Degree of thrombocytopenia(The day of the application of the acupuncture treatment in patients in oncological treatment. In survivors, the last available, up 365 days)
研究者
Esther Martinez Garcia
Head of integrative pediatric oncology. Pediatric Cancer Center Barcelona, Hospital Sant Joan de Deu
Fundació Sant Joan de Déu