Skin NecrosisNCT07340632
B4P Trial - BLOOM43 for Preconditioning
A study testing BLOOM43 in people with Skin Necrosis and Breast Reconstruction, run by Plexaa Ltd.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Skin Necrosis, Breast Reconstruction, Breast Surgery
- What is being tested?
- BLOOM43
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 16 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Hadyn Kankam contact
About this study
Official 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
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).
- Conditions
- Skin Necrosis, Breast Reconstruction, Breast Surgery
- Being tested
- BLOOM43
- Keywords
- Mastectomy skin flap necrosis, Breast reconstruction, Breast surgery, Preconditioning, Skin necrosis
- Medical subject headings
- Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLOOM43Device
BLOOM43 works by delivering heat preconditioning to the breast skin before surgery.
| Study group | Role | What they receive |
|---|---|---|
| All participants (single arm) | Experimental | 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. Receives: Device: BLOOM43 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the device
Monitoring AEs, ARs, SAEs, SARs, UARs and USARs
Measured: 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.
Measured: 30 days
Secondary outcomes (2)
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
Measured: 90 days
Compliance
Proportion of participants who are compliant with the preconditioning protocol
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start16 Apr 2026 (estimated)
- Primary completion16 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Skin NecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Plexaa Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royal Marsden NHS Foundation Trust, Portsmouth Hospitals NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340632
- Sponsor's protocol ID
- B4PTrial
- Other IDs
- NIHR206435
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jeevan R, Cromwell DA, Browne JP, Caddy CM, Pereira J, Sheppard C, Greenaway K, van der Meulen JH. Findings of a national comparative audit of mastectomy and breast reconstruction surgery in England. J Plast Reconstr Aesthet Surg. 2014 Oct;67(10):1333-44. doi: 10.1016/j.bjps.2014.04.022. Epub 2014 May 14.
PubMed 24908545Robertson SA, Jeevaratnam JA, Agrawal A, Cutress RI. Mastectomy skin flap necrosis: challenges and solutions. Breast Cancer (Dove Med Press). 2017 Mar 13;9:141-152. doi: 10.2147/BCTT.S81712. eCollection 2017.
PubMed 28331365Mehta S, Rolph R, Cornelius V, Harder Y, Farhadi J. Local heat preconditioning in skin sparing mastectomy: a pilot study. J Plast Reconstr Aesthet Surg. 2013 Dec;66(12):1676-82. doi: 10.1016/j.bjps.2013.07.034. Epub 2013 Sep 4.
PubMed 24011908Kankam HKN, Mehta S, Jain A. Thermal Preconditioning for Surgery: A Systematic Review. J Plast Reconstr Aesthet Surg. 2020 Sep;73(9):1645-1664. doi: 10.1016/j.bjps.2020.05.025. Epub 2020 May 21.
PubMed 32505626Mehta S, Cro SC, Coomber B, Rolph R, Cornelius V, Farhadi J. A randomised controlled feasibility trial to evaluate local heat preconditioning on wound healing after reconstructive breast surgery: the preHEAT trial. Pilot Feasibility Stud. 2019 Jan 11;5:5. doi: 10.1186/s40814-019-0392-y. eCollection 2019.
PubMed 30656059
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07340632
- Acronym / sponsor ID
- B4PTrial
- Conditions
- Skin Necrosis, Breast Reconstruction, Breast Surgery
- Keywords
- Mastectomy skin flap necrosis, Breast reconstruction, Breast surgery, Preconditioning, Skin necrosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Plexaa LtdIndustry (pharma, biotech, devices)
- Collaborators
- Royal Marsden NHS Foundation Trust, Portsmouth Hospitals NHS Trust
- Study start
- 16 Apr 2026 (estimated)
- Primary completion
- 16 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants (single arm) | Experimental | Device: BLOOM43Each 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLOOM43BLOOM43 works by delivering heat preconditioning to the breast skin before surgery. | Device | All participants (single arm) |
Primary outcome
Safety of the device
Time frame: 90 days
Monitoring AEs, ARs, SAEs, SARs, UARs and USARs
Participant experience
Time frame: 30 days
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.
2 secondary outcomes
Mastectomy skin flap necrosis
Time frame: 90 days
Compliance
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 24908545Jeevan R, Cromwell DA, Browne JP, Caddy CM, Pereira J, Sheppard C, Greenaway K, van der Meulen JH. Findings of a national comparative audit of mastectomy and breast reconstruction surgery in England. J Plast Reconstr Aesthet Surg. 2014 Oct;67(10):1333-44. doi: 10.1016/j.bjps.2014.04.022. Epub 2014 May 14.
- Background: PubMed 28331365Robertson SA, Jeevaratnam JA, Agrawal A, Cutress RI. Mastectomy skin flap necrosis: challenges and solutions. Breast Cancer (Dove Med Press). 2017 Mar 13;9:141-152. doi: 10.2147/BCTT.S81712. eCollection 2017.
- Background: PubMed 24011908Mehta S, Rolph R, Cornelius V, Harder Y, Farhadi J. Local heat preconditioning in skin sparing mastectomy: a pilot study. J Plast Reconstr Aesthet Surg. 2013 Dec;66(12):1676-82. doi: 10.1016/j.bjps.2013.07.034. Epub 2013 Sep 4.
- Background: PubMed 32505626Kankam HKN, Mehta S, Jain A. Thermal Preconditioning for Surgery: A Systematic Review. J Plast Reconstr Aesthet Surg. 2020 Sep;73(9):1645-1664. doi: 10.1016/j.bjps.2020.05.025. Epub 2020 May 21.
- Background: PubMed 30656059Mehta S, Cro SC, Coomber B, Rolph R, Cornelius V, Farhadi J. A randomised controlled feasibility trial to evaluate local heat preconditioning on wound healing after reconstructive breast surgery: the preHEAT trial. Pilot Feasibility Stud. 2019 Jan 11;5:5. doi: 10.1186/s40814-019-0392-y. eCollection 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hadyn Kankam contact
Questions about this trial
What is this clinical trial studying?
A study testing BLOOM43 in people with Skin Necrosis and Breast Reconstruction, run by Plexaa Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saahil Mehta (447711183551, saahil@plexaa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the device (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07340632, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.