B4P Trial - BLOOM43 for Preconditioning

BLOOM43 for Preconditioning (B4P): A Pilot Study to Evaluate the Use of the Plexaa Preconditioning Device (BLOOM43) for Reconstructive Breast Surgery - A Prospective Cohort Multicentre Study

The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in patients undergoing reconstructive breast surgery for breast cancer. 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 breast the evening before undergoing surgery (mastectomy with immediate autologous and/or implant-based reconstruction).

Inclusion Criteria:

• All females over the age of 18 years (no maximum age limit)
• Patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy and immediate breast reconstruction (autologous and/or implant)

Exclusion Criteria:

• Delayed (two-stage) breast reconstruction patients
• Patients undergoing simple mastectomy or wide local excision of a breast tumour
• Inflammatory breast cancer patients
• Patients with ulcerated breast tumours
• Patents with T4 breast cancer
• Presence of open breast skin wounds, or infected or inflamed breast skin
• Presence of a cardiac pacemaker, defibrillator or any other implantable electronic device