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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Plexaa Ltd
- 入组人数
- 60
- 主要终点
- Participant experience
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Delayed (two-stage) breast reconstruction patients
- •Patients undergoing simple mastectomy or wide local excision of a breast tumour
- •Inflammatory breast cancer patients
- •Presence of open breast skin wounds, or infected or inflamed breast skin
- •Presence of a cardiac pacemaker, defibrillator or any other implantable electronic device
研究组 & 干预措施
All participants (single arm)
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.
干预措施: BLOOM43 (Device)
结局指标
主要结局
Participant experience
时间窗: 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.
次要结局
- Mastectomy skin flap necrosis(90 days)
- Compliance(1 day)