Breast Reconstruction, Breast Surgery, Skin Necrosis
Conditions
Keywords
Mastectomy skin flap necrosis, Breast reconstruction, Breast surgery, Preconditioning, Skin necrosis
Brief 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. Participants will use the device to precondition their breast the evening before undergoing surgery (mastectomy with immediate autologous and/or implant-based reconstruction).
Interventions
DEVICEBLOOM43
BLOOM43 works by delivering heat preconditioning to the breast skin before surgery.
Sponsors
Plexaa Ltd
Royal Marsden NHS Foundation Trust
Portsmouth Hospitals NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the device | 90 days | Monitoring AEs, ARs, SAEs, SARs, UARs and USARs |
| Participant experience | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mastectomy skin flap necrosis | 90 days | Proportion of participants experiencing mastectomy skin flap necrosis and the rates of hospital re-admission and surgical re-intervention due to this |
| Compliance | 1 day | Proportion of participants who are compliant with the preconditioning protocol |
Contacts
CONTACTSaahil Mehta
CONTACTHadyn Kankam
Outcome results
None listed