Implant Based Breast Reconstruction
Conditions
Keywords
TIGR® Matrix, Quality of Life
Brief summary
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.
Detailed description
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.
Interventions
DEVICETIGR® Matrix
bioresorbable, synthetic, surgical mesh
Sponsors
AWOgyn
Esculape GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women with histologically confirmed breast cancer or precancerosis or genetic pre- existing conditions with increased risk of breast cancer or with a family history all with an indication for skin sparing or nipple sparing mastectomy (SSM or NSM); or women with indication of prophylactic operation * The health of women must comply with ECOG performance status 0-2 * The decision for the implementation of the TIGR® Matrix was made before and independently from study enrollment * Participant is mentally able to understand the nature, aims, or possible consequences of the clinical investigation * Patient information has been handed out and subject signed informed consent * Participant has attained full age of 18 years
Exclusion criteria
* Pregnancy or breast-feeding patients * Known intolerance to the material, mesh-implants under investigation * Metastatic breast cancer (with a life expectancy \< 5 years) * Medicinal dis-regulated diabetes * Inadequate bone marrow function with neutrophil granulocytes\<1500 and blood plates \< 100.000/µl * Lack or withdrawn of written patients informed consent * Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol * Participant is institutionalized by court or official order (MPDG §27) * Participation in another surgical clinical investigation that influence the surgical technique or outcome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life 12 months after surgery (BREAST-Q) | 12 months after surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days with drain(s) | during hospital stay after surgery | The number of days between placement of drain system and removal of the drain |
| Days of hospital stay | surgery to discharge from hospital | The number of days the participant spend in hospital after surgery |
| Cosmetic outcome | 6, 12, 24 ,36 month after surgery | Domains of cosmesis of BREAST-Q as perceived by the participant as well as perceived by the physician |
| Rate of unplanned conversion operations | minimum of 3 years and a maximum of 5 years after surgery | Rate of unplanned conversion operations (to mastectomy without reconstruction; to mastectomy with reconstruction; to autologous reconstruction) |
| Quality of Life 6, 24, 36 months after surgery (BREAST-Q) | 6, 24, 36 months after surgery | 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 |
| Complication rate of specific complications | minimum of 3 years and a maximum of 5 years after surgery | 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) |
| Complication rate | minimum of 3 years and a maximum of 5 years after surgery | The number and rate of occurrence of major complications, minor complications; Serious Adverse Events (SAEs) and Adverse Events (AEs) |
Countries
Germany
Contacts
CONTACTMarc Thill, Prof.
STUDY_CHAIRMarc Thill, Prof.
AWOgyn
Outcome results
None listed