Antimicrobial Chronic Wound Bandage Treatment

描述(申请人提供)：在两个第一阶段的SBIR资助下，先进光动力技术公司成功地开发了一项PDT专利技术，并获得了专利，该技术已被证明在光消融通常感染慢性伤口的抗生素耐药微生物和生物膜方面是有效的。这项第二阶段SBIR研究方案的主要目标是利用开发的光动力疗法(PDT)技术开发一种可商业化的抗菌伤口绷带。慢性创伤每年折磨着美国1800万人，是我们医疗体系的巨大财政消耗，每年造成数百亿美元的损失。伤口变得慢性是由于愈合延迟或受损，通常是由潜在的医疗条件和/或最常见的感染引起的。除了这个问题，抗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，并已成为一个重大的世界性健康问题，促使医学界寻找抗生素治疗的替代方案。治疗伤口/溃疡感染的另一种抗感染方法将是一项重大的医学进步。这项建议的具体目的是在先前研究的基础上开发和制造一种可商业化的PDT抗菌伤口绷带设计。然后，将在体外对耐抗生素细菌和生物膜进行PDT绷带设计，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绷带进行活体测试，以证明其有效性。这项提案产生的数据将用于申请FDA的监管510k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.