Nipple reconstruction with cross-linked hyaluronic acid after mastectomy
Impact of Nipple Reconstruction in Mastectomized Patients Using Cross-Linked Hyaluronic Acid Injection.
This trial will test whether adding a cross-linked hyaluronic acid injection to areola micropigmentation helps women who had a mastectomy achieve better nipple projection, appearance, and satisfaction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Germans Trias i Pujol Hospital Academic / other |
| Locations | 1 site (Badalona, Barcelona) |
| Trial ID | NCT07008339 on ClinicalTrials.gov |
What this trial studies
This sequential explanatory mixed-methods project first runs a randomized controlled trial comparing areola micropigmentation alone versus micropigmentation plus hyaluronic acid (HA) nipple injection in 138 participants over 36 months at Germans Trias i Pujol Hospital. Primary outcomes include psychosocial and sexual well-being, satisfaction with breast and nipple appearance (Spanish BREAST-Q and a custom tool), and objective nipple projection measured with calipers. Phase 2 consists of qualitative interviews with a purposive sample of women who received HA to explore personal experiences and meanings of the intervention. The design combines quantitative outcome measurement with qualitative depth to explain how HA injection may affect aesthetic and quality-of-life outcomes.
Who should consider this trial
Good fit: Women aged 18 or older undergoing their first nipple-areola complex reconstruction with micropigmentation after mastectomy, with no prior neo‑nipple surgery and at least six months since their last breast surgery are ideal candidates.
Not a fit: Those with known allergy to hyaluronic acid, poor tolerance to needle injections, recent breast surgery (under six months), or who are not seeking nipple reconstruction are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding HA injection could improve nipple projection and cosmetic satisfaction and lead to better psychosocial and sexual wellbeing after reconstruction.
How similar studies have performed: Use of HA for nipple projection is relatively novel with limited prior data, so rigorous evidence on psychosocial and aesthetic benefits is currently sparse.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Badalona, Barcelona
- Hospital Universitario Germans Trias i Pujol — Badalona, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Isabel Granados Navarrete, RN — Germans Trias i Pujol Hospital
- Study coordinator: Isabel Granados Navarrete, RN
- Email: isabelgranados_navarrete@hotmail.com
- Phone: +34 695161506
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.