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

Launched by GERMANS TRIAS I PUJOL HOSPITAL · Jun 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of hyaluronic acid (HA) injections to improve the appearance of the nipple after mastectomy, particularly when combined with a procedure called micropigmentation, which adds color to the nipple area. The goal is to see if adding HA, which helps create a fuller look, can enhance patients' satisfaction with their breast appearance and overall quality of life. The study will involve 138 women who are receiving their first nipple reconstruction and will assess how they feel about their body image and emotional well-being after the procedure.

To participate, women must be over 18 years old and not have allergies to HA. They should have had their last surgery more than six months ago and must be undergoing their first nipple reconstruction. Participants will receive either the standard micropigmentation or micropigmentation plus HA. Throughout the study, participants can expect to answer questions about their satisfaction and well-being, and some will share their personal experiences in interviews. This research is important because it could lead to a less invasive option for nipple reconstruction and improve how care is provided to women after mastectomy.

Gender

FEMALE

Eligibility criteria

• • Quantitative Phase
• * Inclusion Criteria:
• • Women over 18 years of age, or with parental or legal guardian consent.
• At least one of the following criteria:
• Women undergoing their first nipple-areola complex (NAC) reconstruction through micropigmentation and/or:
• • No previous neo-nipple surgery, either unilaterally or bilaterally.
• • Surgical reconstruction of the areola.
• • Surgical reconstruction of the NAC with subsequent retraction of the neo-nipple.
• • More than 6 months since their last surgery.
• - Exclusion Criteria:
• • Allergy to hyaluronic acid.
• • Poor tolerance to needle injections.
• Withdrawal Criteria:
• • Participant's voluntary decision.
• • Complications associated with the technique (allergy, hematoma, etc.).
• • Clinical deterioration preventing the woman from continuing in the study.
• • - Qualitative Phase
• • Participant Profile Characteristics: For the qualitative phase, women who have received NAC reconstruction with HA will be invited to participate, following the maximum variation criterion. To ensure the inclusion of participants with diverse characteristics and capture a wide range of perspectives and experiences on the phenomenon under study, women of varying ages, with different breast cancer diagnoses, and histories of various oncological, surgical, and therapeutic treatments will be selected.