Breast Cancer FemaleBreast Cancer PreventBreast Reconstruction
Investigational drug(s) / intervention(s)
MATTISSE TEC
MATTISSE TEC: Tissue engineering chamber MATTISSE
Study summary
This study is a first in human, two-stage single arm non-comparative study of safety and performance.
The aim of the study is to asses the safety and the clinical performance of a new device : the MATTISSE tissu engineering chamber.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Criteria related to pathology:
* Female patient over 18 Years old
* Patient who required autologous breast reconstruction:
* Immediate unilateral reconstruction after total mastectomy for early-stage breast cancer
* Breast reconstruction after unilateral preventive total mastectomy
* or delayed unilateral reconstruction after total mastectomy for early-stage breast cancer with a tissue expander implantation
* or conversion from implant-based to autologous reconstruction: Patient who had a breast implant during a previous reconstruction after total mastectomy for cancer, and who needs to change it.
* For patient with active cancer: Patient with early-stage cancer (stage 0, I or II, with tumor size \< 50mm, without lymph-node involvement) needing oncological management that does not required radiotherapy after surgery on the breast area or on the flap donor site
* Patient who required Nipple sparing (NSM) or Skin sparing mastectomy (SSM) with a unique surgical approach (same for mastectomy and implant) insertion; or implant removal for patient undergoing autologous conversion, or expender removal for patient undergoing differed reconstruction.
* Autologous reconstruction using Lateral Intercostal Perforator (LICAP) flap or an intercostal thoracic artery perforation flap (LTAP) if oncological conditions do not allow for LICAP harvesting.
* Patient medically fit for surgery without significant comorbidities
* Breast cup-size less than D
* Body mass index \>20 kg/m2 or patient for whom sufficient flap volume is expected according to surgeon's assessment
* Adequate hematopoietic functions
Criteria related to population:
* Subjects who have given free, informed and written consent to participate in the study;
* Patient able to answer questionnaires, able to communicate in the language of the study country;
* Subjects affiliated to a social security schema or entitled to a social security scheme.
Non-inclusion Criteria:
Pathology related criteria:
* Patient undergoing bilateral reconstruction
* Patient undergoing bilateral preventive mastectomy
* Patient undergoing simultaneous contralateral breast reduction, mastopexy, and augmentation
* Previous history of radiotherapy on the breast area or on the flap donor site
* Previous history of breast or axillary surgery that does not allow fat flap dissection
* Presence of pacemaker or metallic prosthesis making patient unsuitable for MRI
* Body mass index \>30 kg/m2
* Taking medication for weight loss at the time of inclusion visit
* Presence of major medical conditions that may compromise patient's health and healing
* Diabetes and a history of gestational diabetes
* Active smoking
* Microangiopathy, Vascular history and all systemic disease (systemic Raynaud's disease)
* Patient with intertrigo or infection or alteration of the surgical site confirmed pre-operatively by clinical examination
* Allergy to anesthetics or contrast media
* Immunocompromised patient (HIV) or patient used immunosuppressants
Population related criteria
* Pregnant patient
* or breastfeeding patient or woman who has nursed a child three months within inclusion
* Participation in a clinical trial in the 3 months prior to the initial visit
* Predicted unavailability during study.
* Patient deprived of liberty or under guardianship.
* Patient unable to give consent
Medical device related criteria
* Allergy to any of the components of the medical device.
EXCLUSION CRITERIA
* Positive or suspicious extemporaneous sentinel node biopsy
* Non integrity of LICAP and LTAP vessels, showed by the pre-operative doppler
* Patient not yet implanted with MATTISSE®, whose cancer stage will finally require radiotherapy treatment
Primary outcome measure(s)
Safety objective: To assess the 6 months surgical complications rate of MATTISSE® TEC implant-based immediate breast reconstruction. Adverse events will be recorded. — 6 months post-surgery Minor complications include:
* Superficial skin necrosis that requires only debridement
* Flap necrosis
* Subcutaneous hematoma: any hematoma requiring surgical exploration
* Inflammatory reaction
* Seroma: defined as that which requires echo-guided puncture at least once after drain removal.
* Pain
* Delayed wound healing/wound dehiscence: any wound healing problems, detected during clinical examination and not requiring an intervention
* Implant malposition
* Superficial Venous Thrombosis (Mondor disease)
* Capsular contracture
Major complications include:
* All complications that lead to MATTISSE® TEC removal:
* Skin necrosis leading to implant exposure
* Infection
* Implant malposition leading to implant exposure
* Device failure or defect: when the implant breaks or collapses, e.g., the base separates from the shell, failure at the time of surgical placement (fracture of the TEC before placement)
* Granuloma.
Performance objective: To assess the efficacy at 6 months post-operation of breast reconstruction using MATTISSE® breast implants in patients undergoing breast reconstitution after total mastectomy surgery for cancer. — 6 months post-surgery Success is defined as:
* Tissue expansion (flap enlargement) from implantation up to 6 months post operation --\> A 50% increase in the expanded size at 6 months compared to initial size flap is considered as a success. Indeed, the optimal growth of the flap is expected at 6 months,
* Tissue expansion will be assessed using MRI at discharge (after surgery) and 6 months post operative. The volume of flap at 6 months will be compared to the flap size initially implanted. All MRI imaging will be assessed by and independent expert radiologist.
Failure is defined as:
* less than 50% increase in the expanded size at 6 months compared to initial size flap MATTISSE® Prothesis removal
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.