Health TrialsbyHealthPanel

B4P Trial - BLOOM43 for Preconditioning

ConditionsSkin NecrosisBreast ReconstructionBreast Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPlexaa Ltd

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • BLOOM43

    Device

    BLOOM43 works by delivering heat preconditioning to the breast skin before surgery.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: All participants (single arm)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety of the device

Monitoring AEs, ARs, SAEs, SARs, UARs and USARs

Time frame
90 days
2

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

Secondary outcomes

1

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
2

Compliance

Proportion of participants who are compliant with the preconditioning protocol

Time frame
1 day

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Plexaa Ltd

Lead sponsor

Royal Marsden NHS Foundation Trust

Collaborator

Portsmouth Hospitals NHS Trust

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: