Safety Issues Clinical Trial
— ACUSAFE2021Official title:
Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study
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 |
Verified date | October 2022 |
Source | Fundació Sant Joan de Déu |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Sant Joan de Deu | Esplugues De Llobregat | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Fundació Sant Joan de Déu |
Spain,
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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