Development of a novel sustained release local anesthetic wound dressing for partial-thickness dermal injuries

项目总结 与浅表和部分厚度真皮伤口相关的疼痛可能是剧烈和持续的。 在整个治愈过程中。不适当的疼痛管理会损害伤口愈合，延长 住院，降低患者满意度，增加医疗成本。由于治疗选择有限， 目前的局麻药配方持续时间短，阿片类镇痛剂是疼痛的中流砥柱 对这些患者的管理，尽管他们与各种不良事件有关。因此，疼痛 由于供应商缺乏安全有效的阿片类药物替代品，皮肤损伤的治疗并不是最佳选择 他们的病人。 109治疗公司正在开发BUPIVADERM，一种新型的药物输送伤口敷料，提供持续的 布比卡因以一种预测性和延伸性的方式输送到部分厚度的真皮伤口。新奇的伤口 敷料将是一种首创的伤口敷料，它提供了传统敷料的伤口愈合特性 湿润创面敷料临床上可用，但增加了安全有效的止痛功能 几天。这种敷料只需要涂一次，一旦重新上皮化，就会无创地剥离。 发生，从而不需要更换敷料或止痛剂。新奇的伤口敷料会 通过提高患者满意度、减轻 阿片类药物的使用，以及减少治疗部分厚度真皮伤口的护理成本。 在初步实验中，我们展示了制造布比卡因微孔的能力。 具有与当前湿金标准相同的尺寸和物理化学性质的聚合物薄膜 伤口敷料，但增加了提供5天持续布比卡因注射的能力。建议数 工作将寻求通过验证安全性来在体内证明这种新型伤口敷料的技术可行性， 我们的原型在标准化的猪皮肤损伤模型中的伤口愈合和止痛效果。止痛药 疗效和持续时间将通过von Frey机械敏感性试验进行评估，伤口愈合将 通过大体和组织学检测进行评估，通过药代动力学评估全身毒性。 评估。拟议的第一阶段工作将证明我们的新型布比卡因缓释伤口 敷料可以提供5天安全有效的非阿片类止痛和非劣质创面愈合 临床相关的临床前模式，这将保证继续商业化努力。

PROJECT SUMMARY The pain associated with superficial and partial-thickness dermal wounds can be intense and sustained throughout the healing process. Inadequate pain management can impair wound healing, prolong hospitalization, decrease patient satisfaction and increase healthcare costs. Due to limited treatment options and the short duration of current local anesthetic formulations, opioid analgesics are the mainstay of pain management for these patients despite their association with a variety of adverse events. Consequently, pain from dermal injury is not optimally treated because providers lack a safe and effective alternative to opioids for their patients. 109 Therapeutics is developing BUPIVADERM, a novel, drug-delivering wound dressing that provides sustained bupivacaine delivery to partial-thickness dermal wounds in a predictive and extended manner. The novel wound dressing will be a first-of-kind wound dressing that provides both the wound healing properties of the traditional moist wound dressings clinically available, but with the added functionality of safe and effective analgesia for 5 days. The dressing will only need to be applied one time and non-traumatically peels off once re-epithelialization occurs, thus eliminating the need for dressing changes or analgesic redosing. The novel wound dressing will provide significant value to patients, clinicians, and society alike by increasing patient satisfaction, mitigating the use of opioids, and reducing cost of care in the treatment of partial-thickness dermal wounds. In preliminary experiments, we have demonstrated the ability to fabricate bupivacaine-loaded microporous polymer films that have the same dimensions and physicochemical properties of the current gold standard moist wound dressings, but with the added ability to provide 5 days of sustained bupivacaine delivery. The proposed work will seek to demonstrate in vivo technical feasibility of the novel wound dressing by validating the safety, wound healing and analgesic efficacy of our prototype in a standardized porcine dermal injury model. Analgesic efficacy and duration will be assessed by von Frey assay of mechanical sensitivity, wound healing will be assessed via gross and histological assays, and systemic toxicity will be assessed via pharmacokinetic assessment. The proposed Phase I work will demonstrate that our novel sustained bupivacaine release wound dressing can provide 5 days of safe and effective non-opioid analgesia and non-inferior wound healing in a clinically relevant pre-clinical model, which would warrant continuation of commercialization efforts.