B4P Trial – BLOOM43 for Preconditioning
Research type
Research Study
Full title
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
IRAS ID
358406
Contact name
Saahil Mehta
Contact email
Sponsor organisation
Plexaa Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 31 days
Research summary
This study is exploring a novel way to help women undergoing breast reconstruction surgery after a mastectomy. The focus is on preventing a common complication called mastectomy skin flap necrosis, where death of the skin happens as it doesn't heal properly after surgery. This can lead to more surgeries and longer hospital stays.
The study will primarily investigate the usability and feasibility of a new device called BLOOM43, which gently heats the skin before surgery. This process, called preconditioning, may help improve healing. Previous research suggests warming the skin can reduce complications, but alternative methods like hot water bottles are unreliable and risky.
The study involves 60 women who are having immediate breast reconstruction surgery following mastectomy. They will use the BLOOM43 device at home the evening before their surgery. The study will take place in two hospitals across the UK. Participants will be monitored for 90 days after their operation.
The research is funded by the Invention for Innovation (i4i) Product Development Award (PDA) won by Plexaa Ltd, who are also the study's sponsor. The findings will help design a larger trial to confirm the device's effectiveness. This could benefit many patients by improving recovery and reducing healthcare costs.
REC name
South East Scotland REC 02
REC reference
26/SS/0032
Date of REC Opinion
5 May 2026
REC opinion
Further Information Unfavourable Opinion