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BIOCHROMADERM® PMCF STUDY

ConditionReconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLaboratoires BIOTIC Phocea

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Trial population

Adult patients requiring the correction of skin pigmentation in the NAC area as a result of breast reconstructive surgery following mastectomy. Up to 115 patients will be included into the study by 3 clinical sites, in order to obtain 103 treated patients followed up over 12 months post-procedure per protocol

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation

Time frame
3 months post-pigmentation

Secondary outcomes

1

To confirm the continued safety of BIOCHROMADERM®

Time frame
12 months
2

To confirm adequate usability and describe the optimal process for BIOCHROMADERM® implantation

Time frame
12 months
3

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)

Time frame
12 months
4

To assess the evolution of performance (Likert scale) between baseline, 3 months and 12 months post-pigmentation

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laboratoires BIOTIC Phocea

Lead sponsor

Clinical Research Consultants, Inc.

Collaborator

Source ClinicalTrials.gov
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