Plexaa For Preconditioning: Gender Affirming Mastectomy

A Pilot Study to Investigate the Use of the Plexaa Preconditioning Device (BLOOM43) for Gender Affirming Mastectomy - a Prospective Cohort Study

The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in transgender and non-binary patients undergoing gender affirming mastectomy. This study aims to understand a participant's experience of the device, including its usability and acceptability.

Participants will use the device to precondition their right breast the evening before undergoing surgery (gender affirming mastectomy).

Inclusion Criteria:

• All transgender or non-binary patients over the age of 18 years (no maximum age limit)
• Patients undergoing peri-areolar mastectomy or double incision mastectomy with a free nipple graft for gender affirmation

Exclusion Criteria:

• Patients undergoing surgery for breast cancer
• Delayed (two-stage) breast reconstruction patients
• Patients undergoing simple mastectomy or wide local excision of a breast tumour
• Presence of open breast skin wounds, or infected or inflamed breast skin
• Presence of a cardiac pacemaker, defibrillator or any other implantable electronic device