Ways of Retaining the Inframammary Fold in Implant-based Breast Surgery

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

March 1, 2022

Primary Completion Date

August 31, 2025

Study Completion Date

February 28, 2026

Conditions
Breast Cancer Stage IBreast Cancer Stage IIIn Situ Breast Cancer
Interventions
PROCEDURE

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.

PROCEDURE

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.

Trial Locations (1)

121205

RECRUITING

The Branch of Hadassah Medical LTD, Moscow

All Listed Sponsors
collaborator

Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

OTHER_GOV

lead

"Branch Office of Hadassah Medical Ltd"

OTHER