The present study will be based on a hybrid breast reconstruction approach with initial skin expansion using the Motiva Flora® Tissue Expander followed by a serial fat grafting session and a final step that includes the placement of a permanent breast implant Ergonomix2®.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
66
This hybrid breast reconstruction involves a stage in which the tissue expander (Motiva Flora®) is used as intended for a conventional expansion. After achieving the desired volume, it is deflated in a controlled way to proceed with the execution of serial fat grafting procedures (reverse expansion). This also means the expander is implanted longer than indicated on its current Directions For Use. Once the reverse expansion is complete, the expander is replaced with a long-term breast implant. Motiva Implants Ergonomix2® Sterile Silicone Breast Implants will be used as per Standard of Care under the CE marked indication. To obtain the safest, most natural, and aesthetic outcomes, Ergonomix2® breast implants have been selected as the standard silicone breast implants for this study.
Universitair Ziekenhuis Gent
Ghent, Belgium
RECRUITINGHospital Universitario San Ignacio
Bogotá, Colombia
NOT_YET_RECRUITINGHospital UNIBE
San José, Costa Rica
NOT_YET_RECRUITINGTotal adverse envent rate
This variable will be assessed by the total incidence, seriousness, severity, causal relationship with the device, measure(s) taken for resolution, outcome, and duration of the various adverse events (AEs) reported during the surgery and follow-up period. The incidence of AEs, in terms of percentage, will be evaluated statistically with a 95% confidence interval. The analysis of the AEs will include: * All AEs reported during the time period in which Motiva Flora® TE remains implanted (up to a maximum of 16 months) * All AEs reported during the conduct of the whole clinical investigation (reconstruction process and 24 months follow-up)
Time frame: 46 months
Surgeon's overall satisfaction
Surgeon's overall satisfaction with reconstruction process and results according to the Global Aesthetic Improvement Scale (GAIS), a 5-point Likert scale: 1) Worse (The appearance is worse than the original condition); 2) No change (The appearance is essentially the same as the original condition); 3) Improved (Obvious improvement in appearance from the initial condition, but a touch-up or retreatment is indicated); 4) Much improved (Marked improvement in appearance from the initial condition, but not completely optimal for this patient. A touch-up would slightly improve the result) and 5) Very much improved (Optimal cosmetic result for the implant in this patient).
Time frame: 46 months
Patient's anxiety and depression
Patient's anxiety and depression using the HADS (The Hospital Anxiety Depression Scale)
Time frame: 46 months
Patient's satisfaction and quality of life impact
Quality of life and satisfaction levels will be assessed using validated international tool Breast-Q.
Time frame: 46 months
Device's performance: Device integrity
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Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Percentage of Tissue Expander devices found without any damage at explantation.
Time frame: 6-16 months
Changes in breast volume
Percentage of cases where enlargement of the initial breast volume was achieved after the fat grafting process and changes in vascularity of the filled zone documented. after the fat grafting process.
Time frame: 46 months
Changes in breast vascularity
Percentage of cases where changes in vascularity of the filled zone were documented after the fat grafting process.
Time frame: 46 months