Early Detection and Wound Monitoring of Pressure Ulcers

描述（由申请人提供）：压疮是临床护理中的严重问题。它们是由不动、潮湿和患者病理引起的（Reddy 2006）。它们会导致许多不良结局，包括感染和截肢，美国的成本为10亿美元，全球为30 - 50亿美元（Salcido 2012，Russo 2006）。护理过程使用重新定位，皮肤检查，专业支持表面和失禁管理。风险量表，如Norton和Braden（NPUAP 1989，Bergstrom 1987），目前用于识别风险较高的患者。虽然这些过程和量表是有效的，但其预测和管理溃疡发生的能力充其量是中等的（绍恩霍芬2002），压迫性溃疡仍然是一项重大的医疗保健成本和不良结局的原因。已知皮肤代谢物含有由组织代谢和皮肤寄生细菌产生的挥发物（Gallagher 2008）。其中许多是氧化应激的标志物（Pabst 2007，Aghdassi 2000，Dumelin 1977）;因此，预计多种标志物会受到导致压力性溃疡的生理应激的影响，并显示出与完整皮肤相比损伤的独特光谱模式。在 为了确保优先于系统或环境信号对溃疡特异性信号进行采样，重要的是对在高危皮肤部位获得的标记进行采样和分析。这将通过使用聚二甲基硅氧烷（PDMS）膜方法（托马斯2010）结合应用纳米技术公司开发的专有离子迁移率传感器技术来完成。（EZKnowz”）。将开发一种廉价的系统，通过便携式床边分析产品对挥发性标记物进行分析，从而早期检测压疮。分析的近实时结果将提供给临床团队，以指导干预措施的使用。具体目标1是开发和优化PDMS膜的VOC捕集方法。具体目标2是开发一个提取接口，并验证生物标志物分析与EZKnowz”技术。具体目标3是测试该方法在压疮临床前模型中的可行性。压疮的早期检测能力将允许更适当地使用干预措施，如减压和微气候控制表面或积极的重新定位，从而以更低的成本获得更好的护理。这方面的一个例子是在区分急诊前，社区获得性溃疡时，患者入院到医疗机构从那些出现在内部护理。正确的分类将使医疗机构管理人员能够适当地获得治疗他们的补偿，而不是将溃疡归类为医院溃疡，从而失去补偿范围。通过降低溃疡发生率和更及时的干预措施，患者结局将得到改善。

DESCRIPTION (provided by applicant): Pressure ulcers are a serious problem in clinical care. They are caused by immobility, moisture, and patient pathologies (Reddy 2006). They cause many poor outcomes including infection and amputation, and costs of $1B in the US and $3B-$5B worldwide (Salcido 2012, Russo 2006). Nursing processes use repositioning, skin checks, specialty support surfaces, and incontinence management. Risk scales such as those of Norton and Braden (NPUAP 1989, Bergstrom 1987) are currently used to identify patients at higher risk. While these processes and scales are valid, their ability to predict and manage ulcer occurrence are modest at best (Schoonhoven 2002) and pressure ulceration remains a significant healthcare cost and cause of poor outcomes. Skin metabolites are known to contain volatiles produced by tissue metabolism and commensal bacteria of the skin (Gallagher 2008). Many of these are markers of oxidative stress (Pabst 2007, Aghdassi 2000, Dumelin 1977); therefore multiple markers are anticipated to be affected by the physiologic stresses which lead to pressure ulceration and to show unique spectral patterns for injury vs. those of intact skin. In order to ensure that ulceration-specific signals are sampled, in preference to systemic or environmental signals, it is important to sample and analyze markers obtained at high-risk skin sites. This will be done by use of polydimethylsilicone (PDMS) membrane methods (Thomas 2010) coupled with a proprietary ion-mobility sensor technology developed by Applied Nanotech, Inc. (EZKnowz"). An inexpensive system will be developed for early detection of pressure ulceration by profiling of volatile markers with a portable, bedside analysis product. The near-real-time results of the analyses will be provided to the clinical team to guide the use of interventions. Specific Aim 1 is to develop and optimize VOC trapping methods with PDMS membranes. Specific Aim 2 is to develop an extraction interface and verify the biomarker analyses with the EZKnowz" technology. Specific Aim 3 is to test the feasibility of the approach in a pre- clinical model of pressure ulceration. An early-detection capability for pressure ulcers will allow for more appropriate use of interventions such as pressure relief and microclimate control surfaces or aggressive repositioning leading to better care for lower costs. One example of this is in distinguishing pre-emergent, community-acquired ulcers upon admission of a patient to a healthcare facility from those appear during in-house care. Correct classification will allow healthcare facility administrators to appropriately obtain reimbursement for treating them rather than have the ulcers classed as nosocomial ulcers, thereby losing out on reimbursement coverage. Patient outcomes will be improved by reduced ulceration rates and more timely interventions.