Pre-pectoral Versus Sub-pectoral Implant Placement in Immediate Breast Reconstruction

NAUnknownINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

August 22, 2019

Primary Completion Date

December 30, 2022

Study Completion Date

December 30, 2023

Conditions
MastectomyBreast Cancer
Interventions
PROCEDURE

immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement.

On the day of surgery, after the completion of the mastectomy, the vascularity of the mastectomy flaps will be evaluated, and debridement is performed where necessary. A temporary implant sizer is placed in the pocket to assess the position and shape of the prepectoral pocket. The pocket is adjusted where necessary. A sheet of ADM (DermAcell) is then selected. The DermAcell will be prepared as per the manufacture's instructions and fenestrated using size 11 blade. The DermACELL piece will be trimmed to the appropriate shape and sutured to the superior medial and lateral edges of the pectoralis major muscle. The inferior edge will be sutured to the fascia at the level of the inframammary fold. Two closed suction drains will be placed (one below the mastectomy skin flap, and one below DermACELL). The implant will be inserted to the pre-pectoral pocket and several anchor sutures will be used to secure the superior-medial edge of DermACELL to mastectomy flap.

PROCEDURE

Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement

On the day of surgery, after the completion of the mastectomy, the vascularity of the mastectomy flaps will be evaluated, and debridement is performed where necessary. The reconstructive operative procedure will then proceeded with (1) elevation of the pectoralis major muscle with release of inferior attachments; (2) placement of implant subpectorally; (3) placement and suturing of DermACELL to constitute the inferolateral breast pocket; (4) placement of two closed suction drains (one superiorly between the pectoralis major and skin, and one inferiorly between the DermACELL and skin); (5) removal of sizer and placement of permanent to the pocket and (6) suture the inferior edge of DermACELL to the inferior edge of the pectoral major muscle. The skin will be closed and the dressing will be applied as standard protocol.

Trial Locations (1)

Unknown

RECRUITING

The Ottawa Hospital, Ottawa

All Listed Sponsors
lead

Ottawa Hospital Research Institute

OTHER