Safety and Clinical Performance of a Biological Matrix Used in Implant-based Breast Reconstruction
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| CELLIS Breast (Porcine Acellular Dermal Matrix, PADM) Implant-based breast reconstruction following mastectomy using the CELLIS Breast matrix |
Device: CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)
Biological membrane used in breast reconstruction
|
Outcome Measures
Primary Outcome Measures
- 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 [From the surgical procedure throughout the entire 24-month follow-up period]
Percentage
Secondary Outcome Measures
- 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). [At the 3, 12 and 24-month follow-up visits]
Described at each visit
- 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). [At the 3, 12 and 24-month follow-up visits]
Percentage of each modality and VAS score described at each visit
- Patient-reported pain using a visual analogue scale (VAS) scored from 0 to 10 (0=no pain; 10=worse pain). [At the 10-day, 30-day, 3-month, 12-month and 24-month follow-up visits]
Described at each visit
- Patient analgesics consumption [At the 10-day, 30-day, 3-month, 12-month and 24-month follow-up visits]
Percentage of analgesics consumption with a Cochrane-Armitage trend test.
- Quality of life (QoL) by the use of the SF-36 questionnaire. [At baseline and at 24 month]
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
- 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. [During the surgical procedure]
Summarized and listed
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient aged ≥18 years,
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Patient with an indication of breast reconstruction after mastectomy (therapeutic or prophylactic),
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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,
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Patient being informed of the porcine origin of the device in advance of the procedure.
Exclusion Criteria:
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Patient with known hypersensitivity to porcine materials,
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Patient with an existing infection at the site of implantation,
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Patient having refused to participate to the study,
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Patient refusing to return for the follow-up visits,
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Patient who is pregnant.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Ambroise Paré | Boulogne-Billancourt | France | 92100 | |
| 2 | Hôpital de la Cavale Blanche, CHRU de Brest | Brest | France | 29609 | |
| 3 | Hôpitaux civils de Colmar | Colmar | France | 68024 | |
| 4 | Hôpital Universitaire Carémeau | Nîmes | France | 30029 | |
| 5 | Hôpital Européen Georges Pompidou | Paris | France | 75015 | |
| 6 | Hôpital Tenon | Paris | France | 75020 | |
| 7 | IUCT Oncopole | Toulouse | France | 31059 |
Sponsors and Collaborators
- Meccellis Biotech
Investigators
- Principal Investigator: Michael ATLAN, MD, Hôpital Tenon, Paris, France
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BR_01_CIP