Clinical trial NCT06360692: Impact of Nipple Micropigmentation in Mastectomized Women
Official title: Impact of Nipple Micropigmentation in Mastectomized Women. Quasi-experimental Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Body Image
Female Sexual Function
Self Esteem
Intimacy With Your Partner
Keywords: breast cancer
nipple tattoing,
micropigmentation
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women undergoing micropigmentation of the areola-nipple complex in mastectomized patients who have undergone breast reconstruction treated in the following services: Plastic Surgery of the General University Hospital of Valencia (Spain), the Breast Micropigmentation Unit of the Puerta del Hierro Hospital in Madrid (Spain) and the Breast Surgery consultation at the San Juan Hospital in Alicante (Spain).

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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.

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.

Eligibility criteria: Inclusion Criteria:

* Having undergone a mastectomy and subsequent breast reconstruction as a result of breast cancer.
* Be able to read and understand the Spanish language.
* Have access to the internet

Exclusion Criteria:

* women who have previously had a nipple tattoo;
* women who refuse to participate in the study;
* pregnant or breastfeeding women.

Primary outcomes:
measure: Body imagen
timeFrame: base, 3 months, 12 months
Secondary outcomes:
measure: Self-esteem
timeFrame: base, 3 months, 12 months
measure: Sexual Function
timeFrame: base, 3 months, 12 months
measure: Intimacy with the partner
timeFrame: base, 3 months, 12 months
Other outcomes:
Locations:
Study officials:
affiliation: CEU-Cardenal Herrera University, CEU universities
name: Marta Lluesma-Vidal, Ph.D
role: PRINCIPAL_INVESTIGATOR
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