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一个严重问题。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后果，包括感染和截肢，在美国造成10亿美元的损失，在全世界造成30 - 50亿美元的损失（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。目前使用Norton和Braden （NPUAP 1989, Bergstrom 1987）等风险量表来识别高风险患者。虽然这些过程和量表是有效的，但它们预测和管理溃疡发生的能力充其量是适度的（Schoonhoven 2002），压疮仍然是一项重大的医疗成本和不良结果的原因。已知皮肤代谢物含有组织代谢和皮肤共生细菌产生的挥发物（Gallagher 2008）。其中许多是氧化应激的标志（Pabst 2007, Aghdassi 2000, Dumelin 1977）；因此，多种标记物预计会受到导致压力性溃疡的生理压力的影响，并显示出与完整皮肤相比独特的损伤光谱模式。在

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.