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

RecruitingNAAges 18 Years - anyFemaleGermans Trias i Pujol Hospital
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In plain words

What the trial is, and whether it could suit you

This study evaluates the impact of hyaluronic acid (HA) injection for nipple projection following mastectomy, as a complement to areola micropigmentation. While micropigmentation is standard in nipple-areola complex (NAC) reconstruction, HA use remains novel, with limited data on psychosocial, sexual, and aesthetic outcomes. A sequential explanatory mixed-methods design will be used. In Phase 1, a randomized controlled trial will compare two groups: one receiving NAC micropigmentation alone (control) and the other receiving micropigmentation plus HA-based nipple projection (intervention). A total of 138 participants will be recruited at the Areolar Micropigmentation Unit of Germans Trias i Pujol University Hospital (Barcelona) over 36 months. Outcomes will include psychosocial and sexual well-being, satisfaction with breast and nipple appearance, and nipple projection, measured using th

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๐Ÿ“‹ Eligibility rules (as published)
* 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.
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What it tests

  • Areola Micropigmentation
  • Hyaluronic Acid Filler Injection
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Where

1 site
Hospital Universitario Germans Trias i Pujol
Badalona, Spain
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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