An interventional study of BLOOM43 in Skin Necrosis, Breast Reconstruction and Breast Surgery, sponsored by Plexaa Ltd. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Plexaa Ltd · Not applicable, Interventional, and Prevention
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).
90 studies on the registry are indexed under Necrosis; 23 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 53 interventional studies indexed under Necrosis.
Browse Necrosis studies →Plexaa Ltd is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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.
Device: BLOOM43
BLOOM43 works by delivering heat preconditioning to the breast skin before surgery.
Safety of the device
Monitoring AEs, ARs, SAEs, SARs, UARs and USARs
Time frame: 90 days
Participant experience
Participants' experience of the device will be evaluated with the use of a questionnaire. Most of the questions will consist of multiple-choice components with a five-point scale and there will also be a section for further comments from participants.
Time frame: 30 days
Mastectomy skin flap necrosis
Proportion of participants experiencing mastectomy skin flap necrosis and the rates of hospital re-admission and surgical re-intervention due to this
Time frame: 90 days
Compliance
Proportion of participants who are compliant with the preconditioning protocol
Time frame: 1 day
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Plexaa Ltd