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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05585463
Other study ID # PS-14-22
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date October 31, 2021

Study information

Verified date October 2022
Source Fundació Sant Joan de Déu
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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®).


Recruitment information / eligibility

Status Completed
Enrollment 460
Est. completion date October 31, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers
Gender All
Age group 1 Day to 34 Years
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
Spain Hospital Sant Joan de Deu Esplugues De Llobregat Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Fundació Sant Joan de Déu

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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