Therapeutic Use of Micro-Sponge Embedded Nutritional Liquid Scaffold for Treatment of Non-Healing Wounds

问题和解决方案：慢性压力性溃疡（PU）是脊髓损伤（SCI）患者再次住院的五大主要原因之一，经常导致感染，生活质量低下，抑郁，甚至死亡风险。仅在加拿大和不列颠哥伦比亚省，治疗SCI患者的PU的费用估计分别为3.657亿美元和4970万美元/年。PU的治疗具有挑战性，因为有3个主要问题：1）存在空腔和空隙空间，这使得它们难以通过常规疗法治疗，2）位于骨突出和身体的承重部位，具有高复发风险，3）治疗前和治疗期间感染的几率很高。为了解决这些困难，我们最近通过在我们正在进行的试点临床试验中开发和使用名为MeshFill的液体营养支架来解决第一个问题。然而，需要更多的研究来解决其他问题。因此，在本研究中，将生成一种新产品（称为MeshFill-Plus），包括：1）液体营养支架（MeshFill），2）海绵状和柔性纳米纤维骨架和3）抗菌纳米银颗粒，并首先在实验室中测试其在感染和对照伤口中的功能，然后在具有与人类相似皮肤的临床前猪伤口模型中进行测试。最后，将向不列颠哥伦比亚省大学/温哥华总医院伦理委员会提交与经测试和优化的MeshFill-Plus的安全性和能力相关的证据，以批准用于治疗12例PU患者的小型临床可行性研究。使用MeshFill-Plus不仅可以自下而上填充所有空腔/隧道，还可以增加愈合伤口的物理强度，并防止在PU上应用时任何潜在细菌的生长。结论：本研究的结果使得将MeshFill-Plus组件组装在医疗包装中成为可能，不仅用于治疗PU，还用于治疗其他非愈合伤口

Problems and Solution: Chronic pressure ulcer (PU) is among the top five leading causes of re-hospitalization in patients with spinal cord injury (SCI) which frequently leads to infections, low quality of life, depression, and even a risk of death. The cost of treating PU in patients with SCI in Canada and BC alone is estimated to be $365.7 and $49.7 million / year, respectively. Treatment of PUs is challenging due to 3 major problems:1) The presence of cavities and void spaces which makes them difficult to to treat by conventional regiments, 2) Locating over bony prominence and weight-bearing parts of the body with a high risk of recurrence, 3) A high chance of infection before and during treatment. To solve these difficulties, we have recently addressed the 1st problem by developing and using liquid nutritional scaffold called MeshFill in our ongoing pilot clinical trial. However, more studies are needed to address the other problems. Thus, in this study, a new product, referred as to MeshFill-Plus consists of: 1) liquid nutritional scaffold (MeshFill), 2) Spongy and flexible nanofiberous skeleton and 3) Antibacterial nano-silver particles will be generated and tested for its functionally in infected and control wounds initially in the lab and then in a pre-clinical pig wound model which has a similar skin to human. Finally, evidence related to the safety and capability of the tested and optimized MeshFill-Plus will be submitted to University of British Columbia / Vancouver General Hospital Ethic Board for approval of small clinical feasibility study for treating 12 patients with PUs. The use MeshFill-Plus not only fills up all cavities/ tunnels from bottom up, it increases the physical strength of healed wounds and prevents the growth of any potential germs when applied on PUs. Conclusion: The result of this study makes it possible to assemble the components of MeshFill-Plus in a medical package for treating not only PUs, but also other non-healingwounds