Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)

Study Overview
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Brief Summary
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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.

Detailed Description
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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®).

Official Title
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Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study

Conditions
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Cancer Pediatric, Neutropenia, Thrombocytopenia, Bacteremia, Infection;Skin;Localised, Safety Issues

Intervention / Treatment
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* Procedure: acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: Pediatric oncology patients who have not received treatment with acupuncture or intracutaneous needles.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 34 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oncology pediatric patients treated with acupuncture<br>Patients in the oncology area of the Sant Joan de Déu Hospital treated at the UOPI (Integrative Pediatric Oncology Unit) from September 2019 to September 2021 have received treatment with acupuncture and intracutaneous Seirin New Pyonex Press Tack®. Patients in active treatment and survivors are included. Acupuncture treatment can be received in a hospitalization ward, an intensive care unit, a day hospital or an outpatient clinic. | Procedure: acupuncture<br>* Acupuncture with needles and intracutaneous needles in the ear or body. The insertion is done with gloves, a guide to puncture the needle, and exhaustive skin disinfection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of local infection | 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. | From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle) | 
| Incidence of bacteremia | 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. | 72 hours after removal intracutaneous needle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bruising or bleeding | To calculate the incidence of bruising or bleeding 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. | From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle) | 
| Incidence of sepsis | To analyze the incidence of sepsis due to gram-positive cocci up to 72 hours after the removal of the intracutaneous Seirin New Pyonex Press Tack® needles. The result can be yes or no. | From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle) | 
| Incidence of skin erosion | Identify other skin erosion related to acupuncture and its related techniques. The result can be yes or no. | From the first day of needle insertion to the fourth day (withdrawal of the intracutaneous needle) | 
| Number of acupuncture needles | Count the number of needles inserted on the day of the event (treatment The result is a minimum of one needle. This data is recorded in all acupuncture interventions and can be consulted in the clinical history. | The day of the application of the acupuncture treatment | 
| Number of intracutaneous needles | Count the number of intracutaneous needles inserted on the day of the event (treatment The result is a minimum of one needle. This data is recorded in all acupuncture interventions and can be consulted in the clinical history. | The day of the application of the acupuncture treatment | 
| Degree of neutropenia | Report the patient's absolute neutrophil count and degree of neutropenia on the day of receiving acupuncture treatment (needles and/or Seirin New Pyonex Press Tack®). The Common Terminology Criteria for Adverse Events (CTCAE) is widely accepted as the standard classification and severity grading scale for adverse events in cancer therapy, clinical trials, and other oncology settings will be used. The lowest degree is 1 and the maximum is 5 | 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 | Report the patient's absolute platelets count and degree of thrombocytopenia on the day receiving acupuncture treatment (needles and/or Seirin New Pyonex Press Tack®). The Common Terminology Criteria for Adverse Events (CTCAE) is widely accepted as the standard classification and severity grading scale for adverse events in cancer therapy, clinical trials and other oncology settings will be used. The lowest degree is 1 and the maximum, 5 | The day of the application of the acupuncture treatment in patients in oncological treatment. In survivors, the last available, up 365 days | 
| Type of acupuncture treatment | • Report whether the applied treatment has been auricular (insertion of Seirin New Pyonex Press Tack® in the auricular pavilion), corporal or mixed (both techniques are performed). This data is recorded in all acupuncture interventions and can be consulted in the clinical history. | The day of the application of the acupuncture treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Intracutaneous Needle, Cancer, Children, Neutropenia, Thrombocytopenia, Infection, Safety, Bacteremia