Development of an Atmospheric Plasma Applicator to Treat Chronic Wounds

描述（由申请人提供）：每年有500万至700万美国人因糖尿病、下肢动脉疾病、下肢静脉疾病、压疮和创伤性损伤（包括烧伤）引起的慢性伤口接受治疗，这表明需要新的先进治疗技术。Advanced Plasma Products将在其成功的I期成果的基础上，推进大气等离子伤口涂抹器（APWA）原型的开发，该原型可以在不损害周围组织的情况下灭活生物膜，从而愈合伤口。该原型将通过不同临床意义菌株和多微生物生物膜的体外伤口生物膜模型来测试其伤口消毒能力。将进行渗透研究，以评估等离子体活性物质在组织中的深度，机制研究将评估等离子体处理使微生物细胞失活的机制。我们将展示大气等离子体通过去除正常和糖尿病小鼠夹板切除伤口生物膜中的微生物以及引入各种气态氮来改善伤口愈合的治疗潜力。第二代原型将在马下肢伤口的临床环境中建造和测试。经过两年的努力，APP将启动FDA 510K监管审批程序。

DESCRIPTION (provided by applicant): Annually, 5 to 7 million Americans are treated for chronic wounds that arise from diabetes, lower extremity arterial disease, lower extremity venous disease, pressure ulcers, and traumatic injuries, including burns, demonstrating the need for new advanced technologies for treatment. Advanced Plasma Products will build upon its successful Phase I results and advance the development of the Atmospheric Plasma Wound Applicator (APWA) prototypes that inactivate biofilm without causing damage to surrounding tissues, thereby healing the wound. The prototype will be tested for its wound disinfecting capabilities with in vitro wound biofilm models of different clinically significant strains and polymicrobial biofilm. Penetration studies will be performed to evaluate the depth of plasma active species in tissue and mechanistic studies will evaluate the mechanism of inactivation of microbial cells by plasma treatment. We will demonstrate the therapeutic potential of atmospheric plasma to improve wound healing by the removal of microorganisms from the biofilm of splinted excisional wounds of normal and diabetic mice and the introduction of various gaseous nitrogen species. A second generation prototype will be built and tested in a clinical setting with equine lower limb wounds. Following this two year effort, APP will initiate FDA 510K regulatory approval process.