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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Reconstruction Following Mastectomy
• Intervention / Treatment: Device: CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)

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 Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Institut Bergonié
  • Boulogne-Billancourt, France, 92100
    • Hôpital Ambroise Paré
  • Colmar, France, 68024
    • Hôpitaux Civils de Colmar
  • Lille, France, 59000
    • Centre Oscar Lambret
  • Lyon, France, 69373
    • Centre léon bérard
  • Paris, France, 75015
    • Hopital Europeen Georges Pompidou
  • Paris, France, 75020
    • Hopital Tenon
  • Saint-Herblain, France, 44 805
    • Institut de Cancérologie de l'Ouest - Site René Gauducheau
  • Toulouse, France, 31059
    • IUCT Oncopole
  • Villejuif, France, 94800
    • lnstitut Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Constitution and follow-up of a consecutive cohort of patients operated with the CELLIS Breast membranes based on the usual practices, the indication and the inclusion-exclusion criteria.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Meccellis Biotech
• Investigators: Principal Investigator: Michael ATLAN, MD, Hôpital Tenon, Paris, France

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Breast reconstruction; Biological membrane
• Other Study ID Numbers: BR_01_CIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No