Safety and Clinical Performance of a Biological Matrix Used in Implant-based Breast Reconstruction

Study Overview
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Brief Summary
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The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Breast membranes used in breast reconstruction and to identify emerging risks in comparison to clinical data related to other treatment modalities. The present study will be a prospective, multicentric, non-randomized and non-controlled trial involving 112 patients followed for 24 months. The study will be conducted in France in 7 investigational centres.

Detailed Description
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The study will be prospective, multicentric, single-arm observational (non-interventional) to evaluate the safety and performance of the CELLIS Breast membranes used in breast reconstruction following mastectomy. All evaluations will be performed and products used according to the usual practice, without additional or unusual diagnostic, treatment and monitoring procedure. The study will be conducted in France in 7 investigational centres including 112 patients scheduled for a breast reconstruction following mastectomy. Each patient will participate in one assessment period including a preoperative visit, followed by the day of surgical procedure and a hospitalization period. Patients will return for ambulatory visits on day 10 (+/- 5 days) and/or on day 30 (+/- 7 days), on month 3 (+/- 2 weeks), on month 12 (+/- 2 weeks) and on month 24 (+/-2 weeks) post-surgery. CELLIS Breast is available in one thickness, in a variety of size and forms addressing multiple surgical techniques.

Official Title
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Porcine Acellular Dermal Matrix (PADM)-Assisted Implant-based Breast Reconstruction: a Prospective Observational Study

Conditions
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Breast Reconstruction Following Mastectomy

Intervention / Treatment
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* Device: CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged ≥18 years, Patient with an indication of breast reconstruction after mastectomy (therapeutic or prophylactic), Patient being informed of her participation to the study and of the follow-up visits, and having no objection to the clinical data collection and medical file access, Patient being informed of the porcine origin of the device in advance of the procedure. Exclusion Criteria: Patient with known hypersensitivity to porcine materials, Patient with an existing infection at the site of implantation, Patient having refused to participate to the study, Patient refusing to return for the follow-up visits, Patient who is pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)<br>Implant-based breast reconstruction following mastectomy using the CELLIS Breast matrix | Device: CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)<br>* Biological membrane used in breast reconstruction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events. Main complications of interest: infection, cellulitis, seroma, hematoma, skin flap-nipple necrosis, delayed wound healing, wound dehiscence, red breast syndrome, capsular contracture, implant related | Percentage | From the surgical procedure throughout the entire 24-month follow-up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient aesthetic evaluation evaluated by Visual Analog Scale (VAS). The suppleness of the reconstruction will be evaluated (natural-hard): VAS score from 1 to 10 (1=very bad suppleness, breast hard; 10=excellent suppleness-natural breast). | Described at each visit | At the 3, 12 and 24-month follow-up visits | 
| Surgeon aesthetic evaluation: satisfaction related to the quality of the reconstruction (very good, good, fair, bad), suppleness (Visual Analog Scale score from 1 to 10 with 10=excellent suppleness) and symmetry (very good, good, fair, bad). | Percentage of each modality and VAS score described at each visit | At the 3, 12 and 24-month follow-up visits | 
| Patient-reported pain using a visual analogue scale (VAS) scored from 0 to 10 (0=no pain; 10=worse pain). | Described at each visit | At the 10-day, 30-day, 3-month, 12-month and 24-month follow-up visits | 
| Patient analgesics consumption | Percentage of analgesics consumption with a Cochrane-Armitage trend test. | At the 10-day, 30-day, 3-month, 12-month and 24-month follow-up visits | 
| Quality of life (QoL) by the use of the SF-36 questionnaire. | Change from screening of each domain score and total score at 24-month. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 with lower scores = more disability, and higher scores = less disability | At baseline and at 24 month | 
| Description of device deficiency: inadequacy of a medical device with respects to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate labelling. | Summarized and listed | During the surgical procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast reconstruction, Biological membrane