Randomized controlled trial to look at early complications, cosmetic outcome, patient satisfaction and thickness of the tissue overlying the implant at the lower pole in immediate implant based breast reconstruction after Skin or Nipple Sparing Mastectomy with either a mesh (TiLOOP Bra) or an ADM (Protexa). Multicenter austrian trial with four breast cancer centers, 50 patients randomized 1:1 in the TiLoop or Protexa group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
50
Medical University of Vienna
Vienna, Austria
complications
hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss
Time frame: up to two weeks after surgery
change of baseline patient quality of life after 3 and 6 months
questionnaire
Time frame: up to two weeks after surgery (=baseline), 3 and 6 months after surgery
change of baseline cosmetic outcome after 3 and 6 months
four point Harris Scale (1=poor, 4=excellent)
Time frame: up to two weeks after surgery (=baseline), 3 and 6 months after surgery
change of baseline thickness of the tissue overlying the implant at the lower pole after 3 and 6 months
The thickness of the tissue covering the implant in the lower pole im mm measured by ultrasound
Time frame: up to two weeks after surgery (=baseline), 3 and 6 months after surgery
complications
hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss
Time frame: 3 months after surgery
complications
hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss
Time frame: 6 months after surgery
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