Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-27 @ 1:17 AM
Study NCT ID:
NCT06360692
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Nipple Micropigmentation in Mastectomized Women
Sponsor:
Cardenal Herrera University
Organization:
Study Overview
Official Title:
Impact of Nipple Micropigmentation in Mastectomized Women. Quasi-experimental Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be a multicenter prospective descriptive case series study following a cohort.
The micropigmentation/tattoo procedure will be carried out following the protocol established in each center (see annex x). The present investigation only involves measuring the impact that this technique has on the patients by collecting data in digital format before and after the CAP micropigmentation/tattoo that motivated their visit to the clinical service.
CAP micropigmentation/tattooing is usually performed between 6 and 12 months after the breast reconstructive surgery has been completed, sufficient time for healing to complete and the breast to stabilize, although it can be performed from 2 months after the intervention. Nurses are responsible for performing micropigmentation/tattooing of the areola and nipple in mastectomized women.
The micropigmentation/tattoo procedure will be carried out following the protocol established in each center (see annex x). The present investigation only involves measuring the impact that this technique has on the patients by collecting data in digital format before and after the CAP micropigmentation/tattoo that motivated their visit to the clinical service.
CAP micropigmentation/tattooing is usually performed between 6 and 12 months after the breast reconstructive surgery has been completed, sufficient time for healing to complete and the breast to stabilize, although it can be performed from 2 months after the intervention. Nurses are responsible for performing micropigmentation/tattooing of the areola and nipple in mastectomized women.
Detailed Description:
The micropigmentation/tattoo procedure will be carried out following the protocol established in each center. This research only involves measuring the impact that this technique has on patients by collecting data in digital format before and after micropigmentation/tattoo.
On the first visit, the patient is informed of the micropigmentation/tattoo technique, its benefits and possible side effects.
If the patient meets the eligibility criteria, the study will be explained to her and she will be asked to sign consent to participate in the study.
In addition, a first assessment of the skin is performed and the design that will be made is explained to the patient. During this first visit, the allergy test is performed, which consists of a minimal injection of pigment in the area where the tattoo will be done. All information is given to the patient in writing and on this occasion the patient signs the informed consent document to consent to this technique being performed. In this visit, data collection corresponding to T0 is carried out. To do this, you will be provided with a QR code that will allow you to access the battery of questionnaires that make up the data collection. In addition, the nurse will complete some of the clinical variables when the patient accesses said link.
Starting the week following the allergy test, the patient can be scheduled for the second visit, and if there is no allergy to the pigment, the micropigmentation/tattoo will be performed after designing the shape, size and color following the hospital's protocol.
The patient will be scheduled again for the micropigmentation/reconstructive tattoo consultation after a month and a half for review and assessment of the need for micropigmentation touch-up.
For the collection of T1 and T2 data, digital notifications will be programmed that will be sent automatically after 3 and 12 months with the link to access the battery of questionnaires. Telephone follow-up will be carried out to avoid losses.
The participants will be evaluated in three times:
T0: baseline measurement at the time of recruitment in the visit with the nurse performing the intervention coinciding with the scheduled appointment for the allergy test.
T1: measurement 3 months after micropigmentation/tattoo. Changes in body image are integrated after 4 weeks17 after any treatment or intervention.
T2: measurement one year after micropigmentation/tattoo.
On the first visit, the patient is informed of the micropigmentation/tattoo technique, its benefits and possible side effects.
If the patient meets the eligibility criteria, the study will be explained to her and she will be asked to sign consent to participate in the study.
In addition, a first assessment of the skin is performed and the design that will be made is explained to the patient. During this first visit, the allergy test is performed, which consists of a minimal injection of pigment in the area where the tattoo will be done. All information is given to the patient in writing and on this occasion the patient signs the informed consent document to consent to this technique being performed. In this visit, data collection corresponding to T0 is carried out. To do this, you will be provided with a QR code that will allow you to access the battery of questionnaires that make up the data collection. In addition, the nurse will complete some of the clinical variables when the patient accesses said link.
Starting the week following the allergy test, the patient can be scheduled for the second visit, and if there is no allergy to the pigment, the micropigmentation/tattoo will be performed after designing the shape, size and color following the hospital's protocol.
The patient will be scheduled again for the micropigmentation/reconstructive tattoo consultation after a month and a half for review and assessment of the need for micropigmentation touch-up.
For the collection of T1 and T2 data, digital notifications will be programmed that will be sent automatically after 3 and 12 months with the link to access the battery of questionnaires. Telephone follow-up will be carried out to avoid losses.
The participants will be evaluated in three times:
T0: baseline measurement at the time of recruitment in the visit with the nurse performing the intervention coinciding with the scheduled appointment for the allergy test.
T1: measurement 3 months after micropigmentation/tattoo. Changes in body image are integrated after 4 weeks17 after any treatment or intervention.
T2: measurement one year after micropigmentation/tattoo.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: