SBIR Phase I: Light Emitting Antimicrobial Bandage

这个SBIR第一阶段项目旨在确定灭活已知会导致手术部位感染的常见临床病原体所需的最佳蓝光剂量，并测试一种利用蓝光的杀菌作用来灭活表面定植细菌并对手术部位进行消毒的抗菌发光敷料原型。拟议活动的潜在结果是开发一种薄的可重复使用的蓝色发光绷带，提供有效的术后部位消毒，最终减少与医院相关的感染。拟议的活动将进一步开发抗菌蓝光疗法设备，为手术部位感染、中线血流相关感染和伤口感染提供新的解决方案，因为蓝光疗法已被证明能够灭活广泛的临床病原体，而无论它们对抗生素的耐药性如何，改善伤口愈合的能力，以及在生物被膜状态下灭活细菌的能力。该项目的成果将有助于为医疗保健相关感染提供节省成本的解决方案，减少它们的发生，降低人为错误的风险，并改善责任、质量和工作流程。临床上需要优化蓝光疗法来杀灭患者手术部位表面的细菌，因为必须通过辐射能量阈值才能灭活细菌。由于以前研究中使用的设备和剂量各不相同，再加上临床上需要一种易于纳入标准感染预防方案的设备，因此需要对设计为可穿戴设备的设备进行进一步的实验，以便临床实施。目的1：确定灭活常见革兰氏阳性和革兰氏阴性细菌所需蓝光(405 Nm)的最佳光剂量(光通量)。采用体外培养技术，确定达到细菌消毒所需的总光通量和处理次数至少减少一个菌落形成单位的对数。目的2：优化装置，在保持表面温度低于43摄氏度的情况下，提供有效的照度，以安全地在组织上使用。该装置的治疗表面不得超过43摄氏度，同时从目标1提供有效的辐射，以灭活表面上的细菌。目的：在SSI猪模型上测试该装置的感染预防和组织反应。在猪SSI模型中评估该装置，表面接种缝合伤口，使其达到筋膜的深度，并使用优化的发光抗菌绷带。细菌消毒的成功标准是每克组织至少减少90%的CFU，或者基于标准的主观临床标志，包括发烧、红斑、硬结和化脓，多参数和半定量评分(0-3范围)不大于1。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

This SBIR Phase I project aims to identify optimal doses of blue light required to inactivate common clinical pathogens known to cause surgical site infections, and test a prototype antimicrobial light emitting dressing that uses the bactericidal effects of blue light to inactivate surface colonizing bacteria and disinfect surgical sites. The potential outcomes of the proposed activity are the development of a thin reusable blue light-emitting bandage that provides effective post-operative site disinfection, ultimately reducing nosocomial related infections. The proposed activity would further the development of antimicrobial blue light therapy devices, providing novel solutions to surgical site infections, Central Line Bloodstream Associated Infections, and wound infections, because of blue light therapy's proven ability to inactivate a wide range of clinical pathogens regardless of their resistance to antibiotics, ability to improve wound healing, and ability to inactivate bacteria in the biofilm state. The outcomes of this project will aid in providing a cost saving solution to Healthcare Associated Infections by reducing their occurrence, reducing the risks of human error, and improving accountability, quality and workflow. Optimization of blue light therapy is needed for clinical application for killing bacteria on the surface of patient's surgical sites, because of a radiant energy threshold that must be passed to inactivate bacteria. Due to the variation in devices and doses used in previous studies, combined with the clinical need for a device which can be easily incorporated into standard infection prevention protocols, further experimentation is needed with a device designed as a wearable for clinical implementation. Objective 1: Determine optimal light dose (fluence) of blue light (405 nm) required to inactivate common gram positive and gram negative bacteria known to cause SSIs. Using in vitro techniques, determine the total fluence of light and treatment times required to achieve bacterial disinfection of at least a one log reduction in bacteria colony forming units. Objective 2: Optimize device to deliver the effective irradiance while maintaining surface temperature below 43 Degree Celsius for safe use on tissue. The device is to not exceed 43 Degree Celsius on the surface of the device's therapeutic surface while delivering effective irradiance, from Objective 1, for inactivation of bacteria on surfaces. Objective 3: Test the device's infection prevention and tissue response in a SSI porcine model. Evaluate the device in a porcine SSI model with surface-inoculated sutured incisions, made to the depth of the fascia, with optimized light-emitting antimicrobial bandage. Success criteria for bacterial disinfection is at least a 90% reduction of CFU per gram of tissue or a multiparametric and semiquantitative score (0-3 range) no greater than 1, based on standard subjective clinical markers, including fever, erythema, induration, and suppuration.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.