BIOCHROMADERM® PMCF STUDY

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-12

Study Completion Date

2027-06-12

Brief Summary

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The goal of this observational study is to:

* To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation;
* To confirm the continued safety of BIOCHROMADERM®,
* To confirm adequate usability and describe the optimal process for BIOCHROMADERM® implantation
* To assess the long-term performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 12 months post-pigmentation (Likert scale)
* To assess the evolution of performance (Likert scale) between baseline, 3 months and 12 months post-pigmentation
* To assess fading (pigment retention potential) over 12 months
* To assess the number of pigmentation adjustments needed per patient throughout the study duration
* To assess patient's satisfaction/self-confidence evolution post-treatment, both in terms of general breast appearance and as to the specific dermo-pigmentation stage
* To assess the correlation of the esthetic satisfaction/self-confidence questionnaire outcomes with those of the Likert Scale and patient satisfaction VAS at 3 months and 12 months post-pigmentation

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Detailed Description

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Conditions

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Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Female or male ≥18 years old,
* Requiring the reconstruction of the nipple-areola complex following mastectomy,
* Affiliated or beneficiary of a social security scheme,
* Able and willing to provide written informed consent to study participation.

Exclusion Criteria

* Known allergy to pigment ingredients
* Active, recent or prior history of skin disease, chronic skin disease, history of hypertrophic scars, skin infection or skin inflammatory disease,
* Patients carrying a prosthesis (especially cardiac),
* Patients presenting with a coagulation disorder,
* Patients scheduled for an MRI within 6 months following pigmentation,
* Patients scheduled for a skin esthetic treatment close to the pigmentation zone (laser, peeling, abrasion, ...) shortly after pigmentation,
* Existing medical condition or organ pathology close to the skin that the Investigator considers may put the patient at risk or compromise their participation in the study,
* Pregnant or breastfeeding female,
* Currently participating to another clinical trial or having participated to a prior clinical trial within 1 month prior to inclusion into the present one,
* Personal strong objection to medical tattooing,
* Psychiatric illness/social situations that would limit ability to consent and/or to compliance with study requirements,
* Under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.

Note: The recent use of permanent wrinkle or lip filling products close to the scheduled pigmentation zone (silicon, PTFE, ...) is a contraindication in the approved product IFU but is not relevant to the breast reconstruction indication.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No