NCT05585463

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 460 (actual)
• Sponsor: Fundació Sant Joan de Déu · Academic / Other
• Sex: All
• Age: 1 Day – 34 Years
• Healthy volunteers: —

Summary

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

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®).

Conditions

• Cancer Pediatric
• Neutropenia
• Thrombocytopenia
• Bacteremia
• Infection;Skin;Localised
• Safety Issues

Interventions

Type	Name	Description
PROCEDURE	acupuncture	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.

Timeline

• Start date: 2019-09-01
• Primary completion: 2021-09-30
• Completion: 2021-10-31
• First posted: 2022-10-18
• Last updated: 2022-10-20

Locations

1 site across 1 country: Spain