Breast NeoplasmsRECHIALNCT07008339
Impact of Nipple Reconstruction in Mastectomized Patients Using Cross-Linked Hyaluronic Acid Injection.
A study testing Areola Micropigmentation and Hyaluronic Acid Filler Injection in people with Breast Neoplasms and Mastectomy, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Mastectomy, Mammaplasty
- What is being tested?
- Areola Micropigmentation and Hyaluronic Acid Filler Injection
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jun 2023to 2 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 16Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
Isabel Granados Navarrete, Nurse, +34695161506, isabelgranados_navarrete@hotmail.com
Isabel Granados Navarrete, Nurse, +34 695161506, isabelgranados_navarrete@hotmail.com
About this study
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.
Read more
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.
Read the detailed description
Breast cancer is the most common malignant neoplasm among women worldwide. Similarly, in Spain, it is also the most prevalent tumor in women, surpassing colorectal cancer. The incidence of this disease in our country has steadily increased over the past decades, with approximately 26,000 cases diagnosed each year, accounting for 25-30% of all female malignancies. For affected individuals, both the disease and its treatment lead to physical and bodily changes, which in turn have significant emotional implications. A woman facing a breast cancer diagnosis and its associated management goes through a critical period in her life. During this time, the altered self-image resulting from various treatment side effects is often accompanied by a fear of losing femininity and self-confidence, with potentially significant repercussions on the patient's quality of life.
Modern society increasingly demands not only the cure of diseases but also the consideration of factors that enhance patients' quality of life. According to data from the Spanish Society of Plastic, Reconstructive and Aesthetic Surgery (SECPRE), of the 36,000 women mentioned above, approximately 64% will require a mastectomy-defined as the surgical removal of the entire affected breast-and 28% will undergo breast reconstruction.
For these women, the final stage of breast reconstruction typically culminates in the reconstruction of the nipple-areola complex (NAC), which, according to DiCenso et al., represents the conclusion of surgical and adjuvant treatments, as well as the end of uncertainty. It symbolizes the transition from patient to survivor. The healing process is not considered complete until the areola and nipple are reconstructed, thus achieving a morphologically complete breast rather than merely restoring volume.
Micropigmentation is a technique involving the deposition of pigment into the skin using ultra-fine needles. It is simple, safe, does not require general anesthesia, and can be performed by trained nurses in outpatient settings. When a neo-nipple has not been created or has retracted, subcutaneous injection of cross-linked hyaluronic acid (HA) can restore lost volume, improve the realism of micropigmentation, and support emotional healing by improving body image and self-esteem. HA is safe, hydrophilic, biocompatible, and widely used in dermal fillers for volume projection.
This study aims to evaluate the impact of HA-based nipple reconstruction in terms of psychosocial and sexual well-being, satisfaction with the breasts and nipples, and the patient's lived experience.
Specific objectives include:
Identifying the sociodemographic and clinical characteristics of the participants.
Assessing differences in psychosocial and sexual well-being, satisfaction with breasts, nipples, and micropigmentation.
Determining nipple projection and HA retention.
Exploring patient experiences with quality of life, self-confidence, and emotional recovery.
Study Design:
This is a mixed-methods study employing a sequential explanatory design. Phase 1 is a randomized controlled trial comparing micropigmentation alone (control) with micropigmentation plus HA injection (intervention). Phase 2 is a descriptive phenomenological study using semi-structured interviews and thematic analysis.
Setting:
Conducted at the Areolar Micropigmentation Unit, Germans Trias i Pujol University Hospital in Barcelona, a high-tech center that treats 53 patients yearly and is staffed by nurses trained in body image and dermoesthetics.
Population:
Women ≥18 undergoing NAC micropigmentation for the first time. Exclusion criteria include HA allergy or intolerance. Sample size: 138 women (69 per group) in Phase 1. Phase 2 will continue until data saturation (typically 5-15 participants).
Measurements:
BREAST-Q (Spanish version) will assess well-being and satisfaction. A custom questionnaire will assess satisfaction with micropigmentation. Nipple projection will be measured with calipers, and HA data recorded. Interviews will explore body image, self-esteem, intimacy, and expectations.
Data Collection:
Patients will be enrolled during UMA visits. After consent, baseline data and BREAST-Q will be collected. Micropigmentation will be done in 2-4 sessions. For the intervention group, HA will be administered 15 days post-micropigmentation in 2-3 dermal injections. Follow-ups include questionnaires post-procedure and at 3 and 6 months.
Analysis:
Quantitative data will be analyzed using SPSS v.29 with descriptive and inferential statistics (t-test, ANOVA, Mann-Whitney U, chi-square). Qualitative data will be analyzed using Braun \& Clarke's method in NVivo. Trustworthiness will be ensured by Lincoln \& Guba's criteria.
Limitations:
Challenges include lack of double-blinding, variable timelines, and emotional vulnerability. Measures include standardized protocols and extended data collection.
Justification:
This is the first study to evaluate HA-based nipple reconstruction performed by advanced practice nurses using validated PROMs. HA offers a minimally invasive, adjustable alternative to surgery with fewer complications. Its application in nurse-led outpatient care is novel.
Ethics:
Approved by the Ethics Committee of Germans Trias i Pujol Hospital. Conducted in compliance with the Declaration of Helsinki, Spanish biomedical regulations, and data protection laws (LOPD 3/2018). Informed consent will be obtained. Data will be pseudonymized and securely stored.
- Conditions
- Breast Neoplasms, Mastectomy, Mammaplasty, Nipple Disorder, Tattooing, Hyaluronic Acid
- Being tested
- Areola Micropigmentation, Hyaluronic Acid Filler Injection
- 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
- Medical subject headings
- Breast Neoplasms, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Areola MicropigmentationProcedure or surgery
Areola micropigmentation performed by trained nurses
Hyaluronic Acid Filler InjectionDevice
Subcutaneous injection of cross-linked hyaluronic acid filler (Juvederm®) for nipple projection.
| Study group | Role | What they receive |
|---|---|---|
| Micropigmentation Only | Active comparator | Participants receive only areola micropigmentation. Receives: Procedure: Areola Micropigmentation |
| Micropigmentation Plus Hyaluronic Acid Filler | Experimental | Participants receive areola micropigmentation and hyaluronic acid filler injection to restore nipple projection. Receives: Device: Hyaluronic Acid Filler Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 3, and 6 months after final injection session
Secondary outcomes (6)
Psychosocial Well-being
Psychosocial well-being assessed using the 'Psychosocial Well-being' domain of the Spanish version of the BREAST-Q questionnaire. This scale ranges from 0 (lowest well-being) to 100 (highest well-being), with higher scores indicating better psychosocial outcomes.
Measured: Baseline, 3 months, and 6 months post-intervention
Sexual Well-being
Sexual well-being assessed using the 'Sexual Well-being' domain of the Spanish version of the BREAST-Q questionnaire. This scale ranges from 0 (lowest sexual well-being) to 100 (highest sexual well-being), with higher scores indicating better outcomes.
Measured: Baseline, 3 months, and 6 months post-intervention
Satisfaction with Breasts
Satisfaction with breast appearance, measured using the 'Satisfaction with Breasts' subscale of the Spanish version of the BREAST-Q questionnaire. This scale ranges from 0 (lowest satisfaction) to 100 (highest satisfaction), with higher scores indicating better outcomes.
Measured: Baseline, 3 months, and 6 months post-intervention
Satisfaction with Micropigmentation
Patient-reported satisfaction with areola micropigmentation, measured using a custom satisfaction questionnaire. Higher scores indicate better satisfaction outcomes.
Measured: Periprocedural
Nipple Projection
Nipple projection (in mm) measured using digital caliper.
Measured: Immediately post-procedure, 3 months, and 6 months
Retention of Hyaluronic Acid
Estimated percentage of projection retained over time compared to immediate post-injection measurement.
Measured: 3 and 6 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start2 Jun 2023
- Primary completion2 Jun 2027 (estimated)
- Study completion2 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ariadna Huertas Zurriaga, RN, Study director, Germans Trias i Pujol HospitalSergio Alonso Fernández, RN, Study director, University of BarcelonaJoan Blanco Blanco, RN, Study director, Universitat de LleidaIsabel Granados Navarrete, RN, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008339
- Sponsor's protocol ID
- PI-23-109
- Acronym
- RECHIAL
- Status last verified
- Jun 2025
- First submitted
- 22 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in this trial will be made available, including text, tables, figures, and appendices. Data will be shared beginning 6 months following publication and will be available to researchers who provide a methodologically sound proposal, subject to approval by the study sponsor and ethics committee. Data access will be granted for the purpose of academic research. Proposals should be submitted to \[contact email or data request URL\].
Publications
Spear SL, Arias J. Long-term experience with nipple-areola tattooing. Ann Plast Surg. 1995 Sep;35(3):232-6. doi: 10.1097/00000637-199509000-00002.
PubMed 7503514Halvorson EG, Cormican M, West ME, Myers V. Three-dimensional nipple-areola tattooing: a new technique with superior results. Plast Reconstr Surg. 2014 May;133(5):1073-1075. doi: 10.1097/PRS.0000000000000144.
PubMed 24776543Martinez P, Jimeno J, Hernanz F, Munoz P. Spanish version of the BREAST-Q(R) 2.0 questionnaire-breast reduction module-: Linguistic, cross-cultural adaptation and validation. Cir Esp (Engl Ed). 2023 Mar;101(3):232-234. doi: 10.1016/j.cireng.2022.10.016. Epub 2022 Oct 18. No abstract available.
PubMed 36265774Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.
PubMed 19644246Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PubMed 18929686Moser A, Korstjens I. Series: Practical guidance to qualitative research. Part 3: Sampling, data collection and analysis. Eur J Gen Pract. 2018 Dec;24(1):9-18. doi: 10.1080/13814788.2017.1375091. Epub 2017 Dec 4.
PubMed 29199486Smallman A, Crittenden T, MiinYip J, Dean NR. Does nipple-areolar tattooing matter in breast reconstruction? A cohort study using the BREAST-Q. JPRAS Open. 2018 Feb 27;16:61-68. doi: 10.1016/j.jpra.2018.01.003. eCollection 2018 Jun.
PubMed 32158811Beasley KL, Weiss MA, Weiss RA. Hyaluronic acid fillers: a comprehensive review. Facial Plast Surg. 2009 May;25(2):86-94. doi: 10.1055/s-0029-1220647. Epub 2009 May 4.
PubMed 19415575Kyriazidis I, Spyropoulou GA, Zambacos G, Tagka A, Rakhorst HA, Gasteratos K, Berner JE, Mandrekas A. Adverse Events Associated with Hyaluronic Acid Filler Injection for Non-surgical Facial Aesthetics: A Systematic Review of High Level of Evidence Studies. Aesthetic Plast Surg. 2024 Feb;48(4):719-741. doi: 10.1007/s00266-023-03465-1. Epub 2023 Aug 10.
PubMed 37563436Ho D, Jagdeo J. Safety and Efficacy of a Volumizing Hyaluronic Acid Filler for Treatment of HIV-Associated Facial Lipoatrophy. JAMA Dermatol. 2017 Jan 1;153(1):61-65. doi: 10.1001/jamadermatol.2016.3827.
PubMed 27806168Sisti A, Grimaldi L, Tassinari J, Cuomo R, Fortezza L, Bocchiotti MA, Roviello F, D'Aniello C, Nisi G. Nipple-areola complex reconstruction techniques: A literature review. Eur J Surg Oncol. 2016 Apr;42(4):441-65. doi: 10.1016/j.ejso.2016.01.003. Epub 2016 Jan 30.
PubMed 26868167Boccola MA, Savage J, Rozen WM, Ashton MW, Milner C, Rahdon R, Whitaker IS. Surgical correction and reconstruction of the nipple-areola complex: current review of techniques. J Reconstr Microsurg. 2010 Nov;26(9):589-600. doi: 10.1055/s-0030-1263290. Epub 2010 Aug 18.
PubMed 20721849Bellman B, von Grote E, Nogueira A. Hyaluronic acid gel filler for nipple enhancement following breast reconstruction. Cutis. 2017 Aug;100(2):107-109.
PubMed 28961285Panettiere P, Marchetti L, Accorsi D. Filler injection enhances the projection of the reconstructed nipple: an original easy technique. Aesthetic Plast Surg. 2005 Jul-Aug;29(4):287-94. doi: 10.1007/s00266-004-0145-y.
PubMed 16044237Sue GR, Seither JG, Nguyen DH. Use of hyaluronic acid filler for enhancement of nipple projection following breast reconstruction: An easy and effective technique. JPRAS Open. 2019 Nov 5;23:19-25. doi: 10.1016/j.jpra.2019.10.003. eCollection 2020 Mar.
PubMed 32158901
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nipple Reconstruction in Mastectomized Patients Using Cross-Linked Hyaluronic Acid Injection.
- ClinicalTrials.gov ID
- NCT07008339
- Acronym / sponsor ID
- RECHIAL / PI-23-109
- Conditions
- Breast Neoplasms, Mastectomy, Mammaplasty, Nipple Disorder, Tattooing, Hyaluronic Acid
- Keywords
- Breast Cancer, Mastectomy, Breast Reconstruction, Nipple-Areola Complex Reconstruction, Nipple Reconstruction, Areola Reconstruction, Hyaluronic Acid, Dermal Fillers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 2 Jun 2027 (estimated)
- Study completion
- 2 Jul 2029 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breast cancer is the most common malignant neoplasm among women worldwide. Similarly, in Spain, it is also the most prevalent tumor in women, surpassing colorectal cancer. The incidence of this disease in our country has steadily increased over the past decades, with approximately 26,000 cases diagnosed each year, accounting for 25-30% of all female malignancies. For affected individuals, both the disease and its treatment lead to physical and bodily changes, which in turn have significant emotional implications. A woman facing a breast cancer diagnosis and its associated management goes through a critical period in her life. During this time, the altered self-image resulting from various treatment side effects is often accompanied by a fear of losing femininity and self-confidence, with potentially significant repercussions on the patient's quality of life.
Modern society increasingly demands not only the cure of diseases but also the consideration of factors that enhance patients' quality of life. According to data from the Spanish Society of Plastic, Reconstructive and Aesthetic Surgery (SECPRE), of the 36,000 women mentioned above, approximately 64% will require a mastectomy-defined as the surgical removal of the entire affected breast-and 28% will undergo breast reconstruction.
For these women, the final stage of breast reconstruction typically culminates in the reconstruction of the nipple-areola complex (NAC), which, according to DiCenso et al., represents the conclusion of surgical and adjuvant treatments, as well as the end of uncertainty. It symbolizes the transition from patient to survivor. The healing process is not considered complete until the areola and nipple are reconstructed, thus achieving a morphologically complete breast rather than merely restoring volume.
Micropigmentation is a technique involving the deposition of pigment into the skin using ultra-fine needles. It is simple, safe, does not require general anesthesia, and can be performed by trained nurses in outpatient settings. When a neo-nipple has not been created or has retracted, subcutaneous injection of cross-linked hyaluronic acid (HA) can restore lost volume, improve the realism of micropigmentation, and support emotional healing by improving body image and self-esteem. HA is safe, hydrophilic, biocompatible, and widely used in dermal fillers for volume projection.
This study aims to evaluate the impact of HA-based nipple reconstruction in terms of psychosocial and sexual well-being, satisfaction with the breasts and nipples, and the patient's lived experience.
Specific objectives include:
Identifying the sociodemographic and clinical characteristics of the participants.
Assessing differences in psychosocial and sexual well-being, satisfaction with breasts, nipples, and micropigmentation.
Determining nipple projection and HA retention.
Exploring patient experiences with quality of life, self-confidence, and emotional recovery.
Study Design:
This is a mixed-methods study employing a sequential explanatory design. Phase 1 is a randomized controlled trial comparing micropigmentation alone (control) with micropigmentation plus HA injection (intervention). Phase 2 is a descriptive phenomenological study using semi-structured interviews and thematic analysis.
Setting:
Conducted at the Areolar Micropigmentation Unit, Germans Trias i Pujol University Hospital in Barcelona, a high-tech center that treats 53 patients yearly and is staffed by nurses trained in body image and dermoesthetics.
Population:
Women ≥18 undergoing NAC micropigmentation for the first time. Exclusion criteria include HA allergy or intolerance. Sample size: 138 women (69 per group) in Phase 1. Phase 2 will continue until data saturation (typically 5-15 participants).
Measurements:
BREAST-Q (Spanish version) will assess well-being and satisfaction. A custom questionnaire will assess satisfaction with micropigmentation. Nipple projection will be measured with calipers, and HA data recorded. Interviews will explore body image, self-esteem, intimacy, and expectations.
Data Collection:
Patients will be enrolled during UMA visits. After consent, baseline data and BREAST-Q will be collected. Micropigmentation will be done in 2-4 sessions. For the intervention group, HA will be administered 15 days post-micropigmentation in 2-3 dermal injections. Follow-ups include questionnaires post-procedure and at 3 and 6 months.
Analysis:
Quantitative data will be analyzed using SPSS v.29 with descriptive and inferential statistics (t-test, ANOVA, Mann-Whitney U, chi-square). Qualitative data will be analyzed using Braun \& Clarke's method in NVivo. Trustworthiness will be ensured by Lincoln \& Guba's criteria.
Limitations:
Challenges include lack of double-blinding, variable timelines, and emotional vulnerability. Measures include standardized protocols and extended data collection.
Justification:
This is the first study to evaluate HA-based nipple reconstruction performed by advanced practice nurses using validated PROMs. HA offers a minimally invasive, adjustable alternative to surgery with fewer complications. Its application in nurse-led outpatient care is novel.
Ethics:
Approved by the Ethics Committee of Germans Trias i Pujol Hospital. Conducted in compliance with the Declaration of Helsinki, Spanish biomedical regulations, and data protection laws (LOPD 3/2018). Informed consent will be obtained. Data will be pseudonymized and securely stored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Micropigmentation Only | Active comparator | Procedure: Areola MicropigmentationParticipants receive only areola micropigmentation. |
| Micropigmentation Plus Hyaluronic Acid Filler | Experimental | Device: Hyaluronic Acid Filler InjectionParticipants receive areola micropigmentation and hyaluronic acid filler injection to restore nipple projection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Women over 18 years of age, or with parental or legal guardian consent.
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Areola MicropigmentationAreola micropigmentation performed by trained nurses | Procedure or surgery | Micropigmentation Only |
| Hyaluronic Acid Filler InjectionSubcutaneous injection of cross-linked hyaluronic acid filler (Juvederm®) for nipple projection. | Device | Micropigmentation Plus Hyaluronic Acid Filler |
Primary outcome
Satisfaction with Nipple Reconstruction
Time frame: 3, and 6 months after final injection session
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."
6 secondary outcomes
Psychosocial Well-being
Time frame: Baseline, 3 months, and 6 months post-intervention
Sexual Well-being
Time frame: Baseline, 3 months, and 6 months post-intervention
Satisfaction with Breasts
Time frame: Baseline, 3 months, and 6 months post-intervention
Satisfaction with Micropigmentation
Time frame: Periprocedural
Nipple Projection
Time frame: Immediately post-procedure, 3 months, and 6 months
Retention of Hyaluronic Acid
Time frame: 3 and 6 months post-injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Background: PubMed 7503514Spear SL, Arias J. Long-term experience with nipple-areola tattooing. Ann Plast Surg. 1995 Sep;35(3):232-6. doi: 10.1097/00000637-199509000-00002.
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- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in this trial will be made available, including text, tables, figures, and appendices. Data will be shared beginning 6 months following publication and will be available to researchers who provide a methodologically sound proposal, subject to approval by the study sponsor and ethics committee. Data access will be granted for the purpose of academic research. Proposals should be submitted to [contact email or data request URL].
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ariadna Huertas Zurriaga, RN study director
Germans Trias i Pujol Hospital
Sergio Alonso Fernández, RN study director
University of Barcelona
Joan Blanco Blanco, RN study director
Universitat de Lleida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Areola Micropigmentation and Hyaluronic Acid Filler Injection in people with Breast Neoplasms and Mastectomy, run by Germans Trias i Pujol Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabel Granados Navarrete, RN (+34 695161506, isabelgranados_navarrete@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with Nipple Reconstruction (time frame: 3, and 6 months after final injection session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07008339, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.