Plexaa: an innovation in preoperative preconditioning for breast cancer surgery patients to prevent wound healing complications and improve outcomes

NHS每年进行1000万次手术(医院事件统计)。其中，大约20%的患者遭受严重的术后并发症(Nepogodiev-2019；国际外科结果研究小组-2016)。这些并发症不仅是潜在的可避免的、有压力的事件，而且延长了住院时间，堵塞了NHS的床位，并推高了治疗费用。NHS的术后并发症管理的挑战和成本预计将每年增加10%。随着我们的人口老龄化(路德布鲁克-2019年)。目前，未愈合的手术伤口占NHS管理的所有伤口的11%(25万名患者)，可归因于每年9.829亿GB的管理费用。(来宾：2017)。这创造了巨大的医疗需求和全球普遍的商业机会。Plexaa开发了提供预适应疗法的技术，手术部位在手术前12小时被加热到43°C的“超生理”水平。这改善了皮肤的血液流动，从而增强了患者的愈合能力，并防止了伤口愈合并发症。这是一种非侵入性的术前干预措施，专注于预防手术并发症的发生。我们之前由NIHR资助的临床研究(预热RCT-2019)证明，这项技术在提高愈合率和预防手术伤口并发症方面非常有效。它还将矫正手术的需求减少了50%，门诊就诊次数减少了70%，每人住院时间减少了3-4天--所有这些都为医疗保健提供者节省了大量成本，估计每个患者的成本为1900-2300 GB。虽然适用于非常广泛的手术，但我们将乳房手术作为初始专科手术。这在一定程度上是由于较高的手术并发症发生率：每年102,000人中约有30%的人需要再次手术，其中20%(20,000人)需要再次手术。我们可以将这一数字减半，改善患者、医院和英国的身体、社会和经济结果，并提供每年近1亿GB的潜在节省。建议的Plexaa设备以适合家庭使用的准确和一致的方式安全地提供预适应。该产品是我们的第一个设备，将引领一系列新的手术预适应产品，解决医院占有率和手术伤口并发症这两个社会和经济问题。

The NHS conducts \>10m operations p.a (Hospital\_Episodes\_statistics). From these, roughly 20% of patients suffer significant postoperative complications (Nepogodiev-2019; International\_Surgical\_Outcomes Study Group-2016). As well as being potentially avoidable, stressful events, these complications extend hospital stays, clog up NHS beds and push up treatment costs.The challenge and cost of managing postoperative complications to the NHS is predicted to increase by 10% p.a. as our population ages (Ludbrook-2019). Currently unhealed surgical wounds account for 11% (\>250,000 patients) of all wounds the NHS manages, with an attributable management cost of £982.9m p.a. (Guest\_2017). This creates a significanthealthcare need and commercial opportunity which is common globally.Plexaa has developed technology which delivers preconditioning therapy, where the surgical site is heated to a "supraphysiological" level, 43°C, 12-hours before surgery. This improves the blood flow to the skin this enhancing the patient's ability to heal and preventing wound healing complications. This is a non-invasive, pre-operative intervention that focusses on preventing surgical complications before they happen.Our previous NIHR-funded clinical research (preHEAT RCT-2019) proved this technique to be extremely effective at improving healing rates and preventing surgical wound complications. It also reduces the need for corrective surgery by 50%, outpatient visits by 70%, and hospital stays by 3-4 days per person -- all of which offer significant cost savings to the healthcare provider, estimated at £1,900-£2,300 per patient.While applicable to a very broad range of surgeries, we are targeting breast surgery as an initial specialisation. In part this is due to high surgical complication rates: ~30% of 102,000 p.a with 20% (\>20,000) needing reoperations. We can halve this number, improving physical, social and economic outcomes for patients, hospitals and the UK and offering potential savings of close to £100m per year.The proposed Plexaa device safely delivers the preconditioning in an accurate and consistent way suitable for home-use.The product represents our first device and will spearhead a new range of pre-conditioning products for surgery, tackling the twin social and economic issues of hospital occupancy and surgical wound complications.