The goal of this observational study is to evaluate the quality of life of participants who have undergone implant-based breast surgery. This will be done using the BREAST-Q questionnaire. The study also aims to demonstrate that the fully resorbable TIGR® Matrix is safe and effective.
This national, multicentre, prospective, non-randomized post market surveillance clinical device investigation will be performed to obtain information on the resorbable surgical mesh TIGR® Matrix used during an implant-based breast surgery. Data will be collected on the participants' quality of life as well as on the rate of complications of the device under investigation.
Study Type
OBSERVATIONAL
Enrollment
135
bioresorbable, synthetic, surgical mesh
GRN-Klinik Weinheim
Weinheim, Baden-Wurttemberg, Germany
ACTIVE_NOT_RECRUITINGKlinik und Poliklinik für Frauenheilkunde Technische Universität München
München, Bavaria, Germany
RECRUITINGAgaplesion Markus Krankenhaus Frankfurt
Frankfurt am Main, Hesse, Germany
Quality of Life 12 months after surgery (BREAST-Q)
Quality of Life will be assessed using the validated Breast-Q patient-reported outcome measure in order to compare the presence, severity and impact of the participants' symptoms on their quality of life and daily activities
Time frame: 12 months after surgery
Quality of Life 6, 24, 36 months after surgery (BREAST-Q)
Quality of Life will be assessed using the validated Breast-Q patient-reported outcome measure in order to compare the presence, severity and impact of the participants' symptoms on their quality of life and daily activities
Time frame: 6, 24, 36 months after surgery
Complication rate
The number and rate of occurrence of major complications, minor complications; Serious Adverse Events (SAEs) and Adverse Events (AEs)
Time frame: minimum of 3 years and a maximum of 5 years after surgery
Complication rate of specific complications
Complication rate of: * Seroma-Volume (Sum of fluid-volume during the drainage-time) * Need for aspiration in symptomatic patients, number of aspirations in postoperative follow up * Reconstructive failure (defined as unplanned implant loss)
Time frame: minimum of 3 years and a maximum of 5 years after surgery
Days with drain(s)
The number of days between placement of drain system and removal of the drain
Time frame: during hospital stay after surgery
Days of hospital stay
The number of days the participant spend in hospital after surgery
Time frame: surgery to discharge from hospital
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Evangelisches Krankenhaus Wesel
Wesel, North Rhine-Westphalia, Germany
RECRUITINGKrankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
Halle, Germany
RECRUITINGCosmetic outcome
Domains of cosmesis of BREAST-Q as perceived by the participant as well as perceived by the physician
Time frame: 6, 12, 24 ,36 month after surgery
Rate of unplanned conversion operations
Rate of unplanned conversion operations (to mastectomy without reconstruction; to mastectomy with reconstruction; to autologous reconstruction)
Time frame: minimum of 3 years and a maximum of 5 years after surgery