Antimicrobial Chronic Wound Bandage Treatment

描述（由申请人提供）：在两个第一阶段SBIR赠款下，Advanced Photodynamic Technologies成功开发了一种专利PDT技术并获得专利，该技术已被证明在抗生素耐药性微生物和通常感染慢性伤口的生物膜的光消融中有效。该SBIR II期研究提案的主要目标是使用已开发的光动力疗法（PDT）技术开发可商业化的抗菌伤口绷带。慢性伤口每年折磨着美国1800万人，并且是我们医疗保健系统的巨大财政消耗，每年占数百亿美元。伤口因愈合延迟或受损而成为慢性伤口，通常由潜在的医疗状况和/或最常见的感染引起。除了这个问题之外，抗生素耐药性细菌的流行已经降低了标准抗生素治疗感染的有效性，并且已经成为一个重要的世界性健康问题，这使得医学界寻找抗生素治疗的替代品。用于治疗伤口/溃疡感染的替代抗感染方式将是重大的医学进步。本提案的具体目的是根据先前研究中确立的规范开发和制造可商业化的PDT抗菌伤口绷带设计。然后将在体外对抗生素耐药细菌和生物膜进行PDT绷带制造设计测试，以优化最终的光敏剂浓度和光剂量。然后将在感染伤口模型上对PDT绷带进行体内测试，以证明疗效。本提案生成的数据将用于申请FDA的监管510 k批准。

DESCRIPTION (provided by applicant): Under two Phase I SBIR grants, Advanced Photodynamic Technologies successfully developed and patented a proprietary PDT technology that has been proven to be effective in the photoablation of antibiotic resistant microorganisms and biofilm that commonly infect chronic wounds. The primary objective of this Phase II SBIR research proposal is to develop a commercializable Antimicrobial Wound Bandage using the developed photodynamic therapy (PDT) technology. Chronic wounds afflict 18 million people in the United States annually and are a tremendous financial drain to our healthcare system, accounting for tens of billions of dollars annually. Wounds become chronic as a result of delayed or impaired healing usually caused by an underlying medical condition and/or most commonly by an infection. In addition to the problem, the prevalence of antibiotic resistant bacteria has diminished the effectiveness of standard antibiotic therapy for infections and has become a significant worldwide health problem that is causing the medical community to search for alternatives to antibiotic treatment. An alternative anti-infective modality for the treatment of wound/ulcer infections would be a significant medical advancement. The specific aim of this proposal is to develop and fabricate a commercializable PDT Antimicrobial Wound Bandage design based on the specifications established in previous studies. The PDT Bandage fabricated design will then be tested in vitro on antibiotic resistant bacteria and biofilm to optimize the definitive photosensitizer concentrations and light dosage. The PDT Bandage will then be tested in vivo on an infected wound model to demonstrate efficacy. The data generated by this proposal will be used to apply for regulatory 510k approval from the FDA.