Clinical trial NCT05031962: Safety and Clinical Performance of a Biological Matrix Used in Implant-based Breast Reconstruction
Official title: Porcine Acellular Dermal Matrix (PADM)-Assisted Implant-based Breast Reconstruction: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Reconstruction Following Mastectomy
Keywords: Breast reconstruction
Biological membrane
Lead sponsor: Meccellis Biotech
Sponsor class: INDUSTRY
First posted: 2021-09-02
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: From the surgical procedure throughout the entire 24-month follow-up period
Secondary outcomes:
measure: 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).
timeFrame: At the 3, 12 and 24-month follow-up visits
measure: 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).
timeFrame: At the 3, 12 and 24-month follow-up visits
measure: Patient-reported pain using a visual analogue scale (VAS) scored from 0 to 10 (0=no pain; 10=worse pain).
timeFrame: At the 10-day, 30-day, 3-month, 12-month and 24-month follow-up visits
measure: Patient analgesics consumption
timeFrame: At the 10-day, 30-day, 3-month, 12-month and 24-month follow-up visits
measure: Quality of life (QoL) by the use of the SF-36 questionnaire.
timeFrame: At baseline and at 24 month
measure: 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.
timeFrame: During the surgical procedure
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré
city: Colmar
country: France
facility: Hôpitaux civils de Colmar
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hôpital Tenon
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest - Site René Gauducheau
city: Toulouse
country: France
facility: IUCT Oncopole
city: Villejuif
country: France
facility: lnstitut Gustave Roussy
Study officials:
affiliation: Hôpital Tenon, Paris, France
name: Michael ATLAN, MD
role: PRINCIPAL_INVESTIGATOR
References: