14
Participants
Start Date
January 20, 2021
Primary Completion Date
January 1, 2024
Study Completion Date
February 13, 2024
Patient Satisfaction Questionnaire
During regular clinical examinations patient will go through a short questionnaire at week 4, 16 and 24 to check patient satisfaction with expanders
Pregnancy test
Pre-op; to sufficiently check pregnancy as exclusion criteria
Blood draw
pre- expander implantation, alongside anaesthesia pre- expander explantation and exchange with definite implant alongside anaesthesia - no additional vein irritation needed
Expander based breast reconstruction
implantation of 2 different expanders intraindividually
Ultrasound of breast
Measurement of capsular thickness pre- expander removal
S(AE )monitoring
(S)AE evaluation will be performed from Visit 1 (Day 0 = Expander implantation) to Visit 15 (Day 168-196 = Reoperation) according to visit plan.
Medical University of Innsbruck, Department for Plastic, Aethetic and Reconstructive Surgery, Innsbruck
Medical University Innsbruck
OTHER