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

NCT07008339 | Recruiting

• 1 other identifier: PI-23-109
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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 the Spanish BREAST-Q, a custom satisfaction tool, and calipers. Phase 2 will involve a qualitative phenomenological study using semi-structured interviews with a purposive sample from the intervention group. Thematic analysis will explore body image, emotional and social well-being, and overall satisfaction, using NVivo software. This is the first study assessing HA nipple reconstruction by advanced practice nurses using validated patient-reported outcomes. While the BREAST-Q is appropriate, it may not fully capture emotional nuances, justifying qualitative exploration. HA durability is estimated at 6-9 months, but residual volume and satisfaction over time remain underexplored. HA's aesthetic footprint may allow reduced dosages in future applications. This minimally invasive technique may reduce the need for surgical nipple reconstruction. Conducting the procedure in a nurse-led setting is novel and may enhance patient-centered care and the role of nursing in post-mastectomy recovery. The study complies with the Declaration of Helsinki and Spanish biomedical regulations. Ethical approval was obtained. Participants will provide informed consent, and data will be anonymized and securely stored.

Conditions

Breast Neoplasms; Mastectomy; Mammaplasty; Nipple Disorder; Tattooing; Hyaluronic Acid; Dermal Fillers; Reconstructive Surgical Procedures; Quality of Life; Self Concept; Body Image; Patient Satisfaction; Breast Reconstruction; Nipple Reconstruction

Keywords

Breast Cancer; Mastectomy; Breast Reconstruction; Nipple-Areola Complex Reconstruction; Nipple Reconstruction; Areola Reconstruction; Hyaluronic Acid; Dermal Fillers; Micropigmentation; Tattooing; Body Image; Quality of Life; Postmastectomy Reconstruction; Cross-linked Hyaluronic Acid; Patient Satisfaction; Breast Cancer Survivors

Outcome Measures

Primary Outcomes (1)

• Satisfaction with Nipple Reconstruction

  Patient-reported satisfaction with nipple reconstruction, measured using the "Satisfaction with Nipple" scale of the Spanish version of the BREAST-Q questionnaire. This scale ranges from 0 to 100, with higher scores indicating greater satisfaction."

  3, and 6 months after final injection session

Secondary Outcomes (6)

• Psychosocial Well-being

  Baseline, 3 months, and 6 months post-intervention

• Sexual Well-being

  Baseline, 3 months, and 6 months post-intervention

• Satisfaction with Breasts

  Baseline, 3 months, and 6 months post-intervention

• Satisfaction with Micropigmentation

  Periprocedural

• Nipple Projection

  Immediately post-procedure, 3 months, and 6 months

Study Arms (2)

Micropigmentation Only

ACTIVE COMPARATOR

Participants receive only areola micropigmentation.

Procedure: Areola Micropigmentation

Micropigmentation Plus Hyaluronic Acid Filler

EXPERIMENTAL

Participants receive areola micropigmentation and hyaluronic acid filler injection to restore nipple projection.

Device: Hyaluronic Acid Filler Injection

Interventions

Areola Micropigmentation PROCEDURE

Areola micropigmentation performed by trained nurses

Micropigmentation Only

Hyaluronic Acid Filler Injection DEVICE

Subcutaneous injection of cross-linked hyaluronic acid filler (Juvederm®) for nipple projection.

Micropigmentation Plus Hyaluronic Acid Filler

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

Study Sites (1)

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

Breast Neoplasms; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ariadna Huertas Zurriaga, RN

  Germans Trias i Pujol Hospital

  STUDY DIRECTOR

• Sergio Alonso Fernández, RN

  University of Barcelona

  STUDY DIRECTOR

• Joan Blanco Blanco, RN

  Universitat de Lleida

  STUDY DIRECTOR

• Isabel Granados Navarrete, RN

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabel Granados Navarrete, RN

CONTACT

+34 695161506; isabelgranados_navarrete@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mixed-methods study with a sequential explanatory design. Phase 1: Quantitative methodology. A parallel, randomized clinical trial developed based on the following hypothesis: nipple reconstruction using hyaluronic acid injection and micropigmentation increases satisfaction and quality of life in mastectomized patients. Phase 2: Qualitative methodology. Constructivist paradigm. Descriptive phenomenological study. The study will be conducted at the Areolar Micropigmentation Unit (UMA) of Germans Trias i Pujol University Hospital, a high-technology public hospital in the province of Barcelona, serving a local population of 250,000 and acting as a referral center for over 800,000 people. The UMA, part of the Breast Pathology Service and collaborating with the Plastic Surgery Department, treats an average of 53 patients per year and is staffed by two nurses specialized in Body Image and Dermoaesthetics.

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 6, 2025
• Study Start: June 2, 2023
• Primary Completion (Estimated): June 2, 2027
• Study Completion (Estimated): July 2, 2029
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6, 12 months after study completion
• Access Criteria: Available upon reasonable request and subject to institutional review

Locations

ES (1)