Study on Nipple Reconstruction After Mastectomy Using Hyaluronic Acid Injection and Areola Micropigmentation in Women

What this Trial Is About

This research is focused on women who have undergone mastectomy and are receiving nipple-areola complex reconstruction. It evaluates the impact of adding hyaluronic acid HA injections to standard areola micropigmentation. The study aims to understand effects on psychosocial and sexual well-being, satisfaction with breast and nipple appearance, and nipple projection. It uses a mixed-methods design, combining a randomized controlled trial with a qualitative study exploring patient experiences. Participants are divided into two groups one receiving only areola micropigmentation and the other receiving micropigmentation plus HA injections to enhance nipple projection. Micropigmentation is performed by trained nurses in outpatient settings over 2 to 4 sessions. For the HA group, injections are given 15 days after micropigmentation in 2 to 3 subcutaneous doses. Follow-up includes questionnaires and measurements immediately after the procedure, and at 3 and 6 months to assess satisfaction and HA retention. During the study, participants complete the Spanish BREAST-Q and custom satisfaction questionnaires. Nipple projection is measured with calipers. A subset of HA-treated participants will take part in interviews to discuss body image and emotional recovery. The primary outcome is satisfaction with nipple reconstruction at 3 and 6 months post-treatment. The total enrollment period extends over 36 months, with ethical approval and data security measures in place.

Impact of Nipple Reconstruction in Mastectomized Patients Using Cross-Linked Hyaluronic Acid Injection.