Diagnostic Tool for the Point-of-Care Detection of Infection in Chronic Wounds

用于即时检测慢性伤口感染的诊断工具

• 批准号: 7538718
• 负责人: Diane Ellis-Edwards
• 金额: $ 43.79万
• 依托单位: ECI BIOTECH
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-06-01 至 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7538718
• 关键词: Acute; Affect; Ambulatory Care Facilities; American; Amputation; Bacteria; Beds; Biological Assay; Biopsy; Biosensor; Caring; Cellulitis; Cessation of life; Chronic; Chronic Care; Clinical; Clinical Research; Collection; Data; Decubitus ulcer; Detection; Development; Devices; Diabetic Foot Ulcer; Diabetic ulcer; Diagnosis; Diagnostic; Diagnostic Sensitivity; Diagnostic tests; Early Intervention; Edema; Endopeptidases; Engineering; Enzyme-Linked Immunosorbent Assay; Erythema; Focal Infection; Goals; Gold; Healed; Health Care Costs; Heating; Hospitals; Impaired wound healing; In Vitro; Individual; Infection; Inflammatory; Intervention; Label; Laboratories; Lateral; Limb structure; Liquid substance; Localized; Long-Term Care; Measures; Methods; Microbiological Techniques; Numbers; Nurses; Osteomyelitis; Pain; Patients; Peptide Hydrolases; Peptides; Performance; Phase; Physicians; Population; Process; Protocols documentation; Public Health; Rate; Reference Standards; Relative (related person); Risk; Sampling; Sensitivity and Specificity; Sepsis; Signs and Symptoms; Site; Standards of Weights and Measures; Surgical wound; Technology; Testing; Tissue Sample; Tissues; Ulcer; Validation; Varicose Ulcer; Venous Insufficiency; Virulence Factors; Visual; Wound Infection; base; diabetic; diagnostic accuracy; healing; improved; novel; novel diagnostics; pathogen; performance tests; point of care; pressure; protease So; rapid detection; tissue culture; tool; wound

DESCRIPTION (provided by applicant): Infection is a major problem for the 5 to 6 million Americans with chronic wounds because it interferes with the normal healing process and increases the risk of serious complications that often necessitate limb amputation or result in death. A significant obstacle to the successful treatment of chronic wounds is the inability to correctly diagnose infection. Most clinicians still rely on visual signs and symptoms that are indicative of infection in acute or surgical wounds but have been proven to be inaccurate for diagnosis of infection in chronic wounds. The primary objective of this proposal is to optimize and validate a novel diagnostic test that will better enable physicians or nurses to detect chronic wound infection at the point-of- care. Our overall objective is produce a simple, single-use diagnostic device for hospitals, wound care clinics, outpatient centers, and long-term care facilities. The device will give a visible, yes-or-no result within 15 minutes when the bacterial concentration within the wound exceeds a level demonstrated to be indicative of infection. This would benefit public health by assisting individuals with chronic wounds to receive the appropriate treatment sooner, which will accelerate the healing process, relieve their suffering and discomfort, and lower the risk of infectious complications. Our Phase I objectives focused on the development of a functional diagnostic assay that was demonstrated to detect bacteria in chronic wounds with excellent diagnostic sensitivity and specificity relative to standard microbiological techniques. Our Phase II specific aims are focused on improvement and validation of the diagnostic test. The first aim is to evaluate a more accurate and reliable method of collecting tissue fluid from chronic wounds. This will help to reduce variability in the sample volume collected, which will improve diagnostic accuracy of the test. Our second objective is to change the assay readout from a quantitative ELISA format into a binary lateral flow-based test. An important step in this process is setting the appropriate threshold for the lateral flow line development using validated standards. Lastly, we plan to evaluate the diagnostic performance of test with samples from patients within the three major chronic wounds types: diabetic, pressure, and venous ulcers. Results of the diagnostic test will be compared to a reference standard for diagnosis of chronic wound infection to calculate the sensitivity and specificity. The data from this clinical study will evaluate the ability of the diagnostic test to detect chronic wound infection and will demonstrate clinical utility of the device. PUBLIC HEALTH RELEVANCE: The project goal is to develop a simple, inexpensive point-of-care diagnostic test to help clinicians rapidly determine if a chronic wound is infected. Earlier and more accurate infection diagnosis will allow patients to receive the appropriate treatment sooner, resulting in less pain and suffering and a lower risk of serious infection-related complications.

描述（由申请人提供）：感染是5至600万慢性伤口的主要问题，因为它会干扰正常的愈合过程，并增加了严重并发症的风险，而严重并发症通常需要肢体截肢或导致死亡。成功治疗慢性伤口的一个重要障碍是无法正确诊断感染。大多数临床医生仍然依赖于急性或外科伤口感染的视觉体征和症状，但事实证明是不准确的慢性伤口感染。该提案的主要目的是优化和验证一种新型的诊断测试，这将使医生或护士能够在护理点检测慢性伤口感染。我们的总体目标是为医院，伤口护理诊所，门诊中心和长期护理设施生产一种简单的一次性诊断设备。当伤口内的细菌浓度超过一个表明感染的水平时，该设备将在15分钟内可见，是或不可能的。这将通过帮助患有慢性伤口的人尽快接受适当的治疗，从而使公共卫生受益，这将加速康复过程，缓解痛苦和不适，并降低感染性并发症的风险。我们的I阶段目标集中在功能诊断测定的开发上，该测定法被证明可检测具有出色诊断敏感性和特异性相对于标准微生物技术的慢性伤口中的细菌。我们的II期特定目标集中于改进和验证诊断测试。第一个目的是评估一种从慢性伤口收集组织液的更准确和可靠的方法。这将有助于降低所收集的样品量的可变性，这将提高测试的诊断准确性。我们的第二个目标是将测定读数从定量ELISA格式更改为基于二进制的侧面流程测试。此过程中的一个重要步骤是使用经过验证的标准为横向流线开发设置适当的阈值。最后，我们计划通过三种主要慢性伤口类型的患者的样本评估测试的诊断性能：糖尿病，压力和静脉溃疡。诊断测试的结果将与慢性伤口感染诊断的参考标准进行比较，以计算敏感性和特异性。这项临床研究的数据将评估诊断测试检测慢性伤口感染的能力，并将证明该设备的临床实用性。公共卫生相关性：项目目标是开发一个简单，廉价的护理诊断测试，以帮助临床医生迅速确定是否感染了慢性伤口。早期，更准确的感染诊断将使患者能够更快地接受适当的治疗，从而减少疼痛和痛苦，并降低与感染相关并发症的严重风险。