Nipple reconstruction with cross-linked hyaluronic acid after mastectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

* 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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing fat processing methods for breast reconstruction after mastectomy

  This study is testing which fat processing method works best for keeping fat grafts in place during breast reconstruction after mastectomy for women who have enough fat to use.

  Recruiting Weill Medical College of Cornell University · New York, New York · NCT04891510

• Improved Facial Skin Quality After VYC-12L for Breast Cancer Survivors

  This study tests whether intradermal injections of VYC-12L can improve facial skin quality and quality of life in adults who have completed breast cancer treatment.

  Recruiting Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Murcia, Murcia · NCT07917117

• Erector spinae plane block for managing pain after breast cancer surgery

  This study is testing if a special nerve block combined with a medication can help reduce pain and improve recovery for women after breast cancer surgery.

  Recruiting at 2 sites Peking University First Hospital · Beijing, Beijing Municipality and 1 other locations · NCT05494502

• Comparing cosmetic results and patient satisfaction of two breast surgery techniques

  This study is trying to see if a newer breast surgery technique gives better cosmetic results and patient satisfaction compared to a traditional method for women under 65 with breast cancer.

  Recruiting National Institute of Oncology, Hungary · Budapest · NCT04345081

• How a patient experience check-in helps people in intermediate and long-term care feel more trusted in the hospital

  This study tests whether identifying and acting on patient concerns in intermediate and long-term care units can help older patients trust the hospital more and reduce complaints.

  Recruiting Consorci Sanitari de l'Alt Penedès i Garraf · Vilanova i la Geltrú, Barcelona · NCT07926815

• ESP Blocks to Help Pain After Breast Reconstruction with Autologous Flaps

  This study tests whether erector spinae plane blocks can improve pain control after autologous free flap breast reconstruction in adults.

  Recruiting Phase 1 Carilion Clinic · Roanoke, Virginia · NCT07891039

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.