B4P Trial - BLOOM43 for Preconditioning

Plexaa Ltd

Status: Begins enrollment in 1 month

Conditions: Breast Reconstruction; Breast Surgery; Skin Necrosis

Treatments: Device: BLOOM43

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07340632

NIHR206435 (Other Identifier)

B4PTrial

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Presence of open breast skin wounds, or infected or inflamed breast skin
• Presence of a cardiac pacemaker, defibrillator or any other implantable electronic device

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

All participants (single arm)

Experimental group

Description:

Each patient will be given the device, BLOOM43, for use at home. It will be worn in a patient's existing bra over their ipsilateral breast (the breast to be operated on) and the preconditioning protocol will be undertaken 12 hours before surgery - i.e. the evening before. Patients will then attend hospital for their breast surgery the next day as planned. For the patients undergoing bilateral skin/nipple-sparing mastectomy with immediate reconstruction, they will be asked to precondition only the right breast.

Treatment:

Device: BLOOM43