Reconstruction Of The Nipple Areola Complex In Patients Undergoing Breast Reconstructive Surgery Following Mastectomy

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Review clinical trials related to Reconstruction Of The Nipple Areola Complex In Patients Undergoing Breast Reconstructive Surgery Following Mastectomy. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

BIOCHROMADERM® PMCF STUDY

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

Participants needed: 115
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Laboratoires BIOTIC PhoceaUpdated: Dec 3, 2025Locations: 3
Eligibility criteria

Female or male ≥18 years old, [+3]

Known allergy to pigment ingredients [+11]