Antimicrobial Microbead Containing Topical Gel for Burn Wound Disinfection

描述（由申请人提供）：在美国，每年有超过40,000例与烧伤有关的住院治疗，其中超过75%的住院患者进入美国127个烧伤中心，导致医疗费用超过100亿美元。烧伤创面可能通过患者自身正常菌群的自我感染或医疗保健提供者或机构与患者之间的医院感染而感染。为了预防和/或治疗这些感染，在伤口部位局部应用抗菌药物。最常用的局部治疗方法是通过化合物（例如，磺胺嘧啶银）或敷料释放银离子。虽然银可以作为一种有效的抗菌剂，但根据递送载体的不同，细胞毒性可能导致白细胞减少，并通过抑制上皮再生阻碍伤口愈合。因此，提出了一种新的广谱抗菌外用材料。这项研究工作的总体目标是展示一种新的有效的、广谱的、生物相容性的、可生物降解的抗菌材料，用于治疗烧伤创面感染。以下目标的实现将证明所提议的局部抗菌剂的可行性-(1)证明抗菌剂从完全生物相容性和可生物降解的底物中释放；(2)在体外和体内对多种烧伤创面相关病原微生物具有广谱抗菌作用；(3)通过体外细胞毒性筛选证明材料的潜在安全性；(4)针对市售局部治疗的基准抗菌功能。在二期后续工作中，将优化抗菌药物配方，完善配药机制，扩大体内实验。最终产品有望成为一种易于使用和易于应用的局部凝胶。

DESCRIPTION (provided by applicant): In the U.S. there are more than 40,000 hospitalizations annually related to burn injury, with more than 75% of these admissions to the 127 U.S burn centers resulting in more than $10 billion in healthcare costs. Burn wounds may become infected through patient self infection from their own normal flora or by nosocomial infection between healthcare provider or facility and the patient. To prevent and/or treat these infections topical antimicrobial agents are applied at the wound site. The most commonly applied topical treatments are based on the release of silver ions through a compound (e.g., silver sulfadiazine) or dressing. Although silver can act as a potent antimicrobial, depending on the delivery vector cytotoxicity may result in leukopenia and impeded wound healing through inhibition of epithelial regeneration. Therefore a new broad spectrum antimicrobial topical material is proposed. The overall objective of this research effort is to demonstrate a new potent, broad spectrum, biocompatible, and biodegradable antimicrobial material for treating burn wound infections. Achievement of the following aims will demonstrate the feasibility of the proposed topical antimicrobial - (1) demonstrate release of antimicrobial agent from a full biocompatible and biodegradable substrate; (2) demonstrate broad spectrum antimicrobial function against multiple burn wound-related pathogenic microorganisms in vitro and in vivo; (3) demonstrate potential safety of material through in vitro cytotoxicity screening; and (4) benchmark antimicrobial function against commercially available topical treatments. In the Phase II follow on effort antimicrobial formulation will be optimized, dispensing mechanism will be refined and in vivo experimentation will be expanded. The final product is expected to be an easy-to- use and easy-to-apply topical gel.