100
Participants
Start Date
March 1, 2022
Primary Completion Date
August 31, 2025
Study Completion Date
February 28, 2026
Implant-based breast reconstruction using polytetrafluoroethylene mesh
Patients will undergo subcutaneous or skin-sparing mastectomy using the standard technique. Simultaneously, breast reconstruction will be performed using a breast implant. The lower pole of the implant and the inframammary fold will be additionally reinforced with polytetrafluoroethylene (PTFE) mesh. The lower edge of the mesh is sutured in the projection of the inframammary fold, and the upper edge is sutured to the pectoralis major muscle.
Implant-based breast reconstruction using Allogeneic dura mater graft
Patients will undergo subcutaneous or skin-sparing mastectomy using the standard technique. Simultaneously, breast reconstruction will be performed using a breast implant. The lower pole of the implant and the inframammary fold will be additionally reinforced with an allogeneic dura mater graft. The lower edge of the mesh is sutured in the projection of the inframammary fold, and the upper edge is sutured to the pectoralis major muscle.
RECRUITING
The Branch of Hadassah Medical LTD, Moscow
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
OTHER_GOV
"Branch Office of Hadassah Medical Ltd"
OTHER