用于慢性伤口生物负荷实时采样和治疗指导的即时床旁自体荧光成像：首例人体试验结果
Point-of-care autofluorescence imaging for real-time sampling and treatment guidance of bioburden in chronic wounds: first-in-human results.
作者信息
DaCosta Ralph S, Kulbatski Iris, Lindvere-Teene Liis, Starr Danielle, Blackmore Kristina, Silver Jason I, Opoku Julie, Wu Yichao Charlie, Medeiros Philip J, Xu Wei, Xu Lizhen, Wilson Brian C, Rosen Cheryl, Linden Ron
机构信息
Princess Margaret Cancer Centre, University Health Network and University of Toronto, Toronto Medical Discovery Tower, 15th floor, 101 College St., Toronto, Ontario, M5G 1L7, Canada; Techna Institute for Advancement of Technologies for Health, University Health Network, 100 College Street, Rm. 124, Toronto, Ontario, M5G 1L5, Canada.
Princess Margaret Cancer Centre, University Health Network and University of Toronto, Toronto Medical Discovery Tower, 15th floor, 101 College St., Toronto, Ontario, M5G 1L7, Canada.
出版信息
PLoS One. 2015 Mar 19;10(3):e0116623. doi: 10.1371/journal.pone.0116623. eCollection 2015.
BACKGROUND
Traditionally, chronic wound infection is diagnosed by visual inspection under white light and microbiological sampling, which are subjective and suboptimal, respectively, thereby delaying diagnosis and treatment. To address this, we developed a novel handheld, fluorescence imaging device (PRODIGI) that enables non-contact, real-time, high-resolution visualization and differentiation of key pathogenic bacteria through their endogenous autofluorescence, as well as connective tissues in wounds.
METHODS AND FINDINGS
This was a two-part Phase I, single center, non-randomized trial of chronic wound patients (male and female, ≥18 years; UHN REB #09-0015-A for part 1; UHN REB #12-5003 for part 2; clinicaltrials.gov Identifier: NCT01378728 for part 1 and NCT01651845 for part 2). Part 1 (28 patients; 54% diabetic foot ulcers, 46% non-diabetic wounds) established the feasibility of autofluorescence imaging to accurately guide wound sampling, validated against blinded, gold standard swab-based microbiology. Part 2 (12 patients; 83.3% diabetic foot ulcers, 16.7% non-diabetic wounds) established the feasibility of autofluorescence imaging to guide wound treatment and quantitatively assess treatment response. We showed that PRODIGI can be used to guide and improve microbiological sampling and debridement of wounds in situ, enabling diagnosis, treatment guidance and response assessment in patients with chronic wounds. PRODIGI is safe, easy to use and integrates into the clinical workflow. Clinically significant bacterial burden can be detected in seconds, quantitatively tracked over days-to-months and their biodistribution mapped within the wound bed, periphery, and other remote areas.
CONCLUSIONS
PRODIGI represents a technological advancement in wound sampling and treatment guidance for clinical wound care at the point-of-care.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01651845; ClinicalTrials.gov NCT01378728.
背景
传统上，慢性伤口感染是通过白光下的目视检查和微生物采样来诊断的，这两种方法分别具有主观性和不够理想的问题，从而延误了诊断和治疗。为了解决这一问题，我们开发了一种新型手持式荧光成像设备（PRODIGI），它能够通过关键致病细菌的内源性自发荧光以及伤口中的结缔组织进行非接触、实时、高分辨率的可视化和鉴别。
方法和结果
这是一项分为两部分的I期单中心非随机试验，研究对象为慢性伤口患者（男女不限，≥18岁；第1部分的UHN REB编号为#09 - 0015 - A；第2部分的UHN REB编号为#12 - 5003；第1部分的clinicaltrials.gov标识符为NCT01378728，第2部分为NCT01651845）。第1部分（28例患者；54%为糖尿病足溃疡，46%为非糖尿病伤口）确定了自发荧光成像准确指导伤口采样的可行性，并与基于盲法、金标准拭子的微生物学进行了验证。第2部分（12例患者；83.3%为糖尿病足溃疡，16.7%为非糖尿病伤口）确定了自发荧光成像指导伤口治疗并定量评估治疗反应的可行性。我们表明，PRODIGI可用于原位指导和改善伤口的微生物采样和清创，实现慢性伤口患者的诊断、治疗指导和反应评估。PRODIGI安全、易于使用且可融入临床工作流程。临床上显著的细菌负荷可在数秒内检测到，在数天至数月内进行定量跟踪，并绘制其在伤口床、周边及其他远处区域的生物分布。
结论
PRODIGI代表了临床伤口护理即时护理中伤口采样和治疗指导方面的技术进步。
试验注册
ClinicalTrials.gov NCT01651845；ClinicalTrials.gov NCT01378728。
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