Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy
Conditions
Brief summary
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
Interventions
None listed
Sponsors
Clinical Research Consultants, Inc.
Laboratoires BIOTIC Phocea
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation | 3 months post-pigmentation |
Secondary
| Measure | Time frame |
|---|---|
| To confirm adequate usability and describe the optimal process for BIOCHROMADERM® implantation | 12 months |
| 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) | 12 months |
| To assess the evolution of performance (Likert scale) between baseline, 3 months and 12 months post-pigmentation | 12 months |
| To confirm the continued safety of BIOCHROMADERM® | 12 months |
| To assess the number of pigmentation adjustments needed per patient throughout the study duration | 12 months |
| 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 | 12 months |
| 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 | 12 months |
| To assess fading (pigment retention potential) over 12 months | 12 months |
Countries
France
Contacts
Primary ContactMarie-Hélène BACHELEY
Outcome results
None listed