Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID07008339

Impact of Nipple Reconstruction Using Cross-Linked Hyaluronic Acid Injection and Areola Micropigmentation in Women After Mastectomy

Led by Germans Trias i Pujol Hospital · Updated on 2025-06-06

138

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research is focused on women who have undergone mastectomy and are receiving nipple-areola complex reconstruction. It evaluates the impact of adding hyaluronic acid (HA) injections to standard areola micropigmentation. The study aims to understand effects on psychosocial and sexual well-being, satisfaction with breast and nipple appearance, and nipple projection. It uses a mixed-methods design, combining a randomized controlled trial with a qualitative study exploring patient experiences. Participants are divided into two groups: one receiving only areola micropigmentation and the other receiving micropigmentation plus HA injections to enhance nipple projection. Micropigmentation is performed by trained nurses in outpatient settings over 2 to 4 sessions. For the HA group, injections are given 15 days after micropigmentation in 2 to 3 subcutaneous doses. Follow-up includes questionnaires and measurements immediately after the procedure, and at 3 and 6 months to assess satisfaction and HA retention. During the study, participants complete the Spanish BREAST-Q and custom satisfaction questionnaires. Nipple projection is measured with calipers. A subset of HA-treated participants will take part in interviews to discuss body image and emotional recovery. The primary outcome is satisfaction with nipple reconstruction at 3 and 6 months post-treatment. The total enrollment period extends over 36 months, with ethical approval and data security measures in place.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 years or older, or with parental or legal guardian consent
  • Undergoing first nipple-areola complex reconstruction by micropigmentation
  • No previous neo-nipple surgery (unilateral or bilateral)
  • Surgical reconstruction of the areola
  • Surgical reconstruction of the nipple-areola complex with subsequent nipple retraction
  • More than 6 months since last breast surgery
Not Eligible

You will not qualify if you...

  • Allergy to hyaluronic acid
  • Poor tolerance to needle injections
  • Voluntary withdrawal from the study
  • Complications related to the procedure (e.g., allergy, hematoma)
  • Clinical deterioration preventing continued participation in the study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 1 to 2 months

Participants undergo areola micropigmentation in 2 to 4 sessions. Those in the intervention group receive subcutaneous injections of cross-linked hyaluronic acid filler 15 days after micropigmentation in 2 to 3 injections to restore nipple projection.

2 to 4 micropigmentation sessions and 1 to 3 hyaluronic acid injection visits depending on group assignment

Follow-up

Duration - Up to 6 months post-treatment

Participants complete questionnaires assessing satisfaction with nipple reconstruction, psychosocial and sexual well-being, and nipple projection measurements are taken to evaluate outcomes and retention of hyaluronic acid.

Visits at 3 months and 6 months after final injection session

Trial Site Locations

Total: 1 location

1

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, Spain, 08916

Actively Recruiting

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Research Team

I

Isabel Granados Navarrete, RN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Spanish version of the BREAST-Q® 2.0 questionnaire-breast reduction module-: Linguistic, cross-cultural adaptation and validation.

Paula Martínez, Jaime Jimeno, Fernando Hernanz...

https://pubmed.ncbi.nlm.nih.gov/36265774

Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

Paul A Harris, Robert Taylor, Robert Thielke...

https://pubmed.ncbi.nlm.nih.gov/18929686

Adverse Events Associated with Hyaluronic Acid Filler Injection for Non-surgical Facial Aesthetics: A Systematic Review of High Level of Evidence Studies.

Ioannis Kyriazidis, Georgia-Alexandra Spyropoulou, George Zambacos...

https://pubmed.ncbi.nlm.nih.gov/37563436