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

开发一种新型缓释局麻药伤口敷料，用于治疗部分皮层真皮损伤

基本信息

批准号：
10325534
负责人：
Brett Davis
金额：
$ 25.66万
依托单位：
REBEL MEDICINE INC
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-30 至 2022-10-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10325534
关键词：
Absence of pain sensation Address Adverse event Analgesics Anesthetics Animal Model Area Biocompatible Materials Biological Assay Biological Sciences Bupivacaine Cessation of life Cicatrix Client satisfaction Clinic Clinical Collaborations Constipation Control Groups Development Dimensions Doctor of Philosophy Dose Drug Delivery Systems Drug Kinetics Epithelial FDA approved Family suidae Film Formulation Gold Health Care Costs Healthcare Systems Histologic Hospitalization Hospitals Hour Impaired cognition Impaired wound healing Infection prevention Infiltration Injury Local Anesthetics Measures Mechanics Mission Modeling Nausea Opioid Opioid Analgesics Pain Pain management Patient-Focused Outcomes Patients Permeability Pharmacology Phase Plasma Polymers Pre-Clinical Model Process Property Provider Recording of previous events Research Resources Safety Sedation procedure Site Skin graft Skin injury Societies Standardization Sterile coverings Structure Surface Technology Testing Therapeutic Thick Time Universities Utah Ventilatory Depression Withdrawal Work Wound models addiction caprolactone care costs clinically relevant commercialization experience experimental study flexibility healing improved in vivo infection rate mechanical force mechanical properties non-opioid analgesic novel novel therapeutics opioid sparing pain reduction poly(lactide)pre-clinical research prototype readmission rates response second degree burn skin wound standard of care systemic toxicity water vapor wound dressing wound healing wound treatment

项目摘要

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.

项目摘要与表面和部分厚性皮肤伤口相关的疼痛可能是强烈的，并且可以持续在整个康复过程中。疼痛管理不足会损害伤口愈合，延长住院，降低患者满意度并增加医疗保健成本。由于治疗选择有限，当前局部麻醉配方的短期，阿片类镇痛药是疼痛的支柱这些患者的管理与各种不良事件相关。因此，痛苦从真皮损伤中没有得到最佳治疗，因为提供者缺乏阿片类药物的安全有效替代品他们的病人。 109 Therapeutics正在开发Bupivaderm，这是一种新颖的毒品伤口敷料，可提供持续的布比卡因以预测性和扩展方式递送到部分厚性皮肤伤口。新颖的伤口敷料将是首个伤口敷料，既可以提供传统的伤口愈合特性潮湿的伤口敷料在临床上可用，但具有5个安全有效镇痛功能的功能5 天。调味料只需要一次应用，并且一旦重新上皮化就可以非创新剥落发生，从而消除了对敷料变化或镇痛的需求。新颖的伤口敷料将通过提高患者满意度，为患者，临床医生和社会提供重要价值使用阿片类药物，并降低了部分厚性皮肤伤口的护理成本。在初步实验中，我们已经证明了制造布比卡因的微孔的能力具有相同尺寸和物理化学特性的当前金标准潮湿的聚合物膜伤口敷料，但具有5天持续布比卡因的能力。提议工作将寻求通过验证安全性来证明新颖伤口敷料的体内技术可行性在标准化的猪真皮损伤模型中，我们的原型的伤口愈合和镇痛功效。镇痛功效和持续时间将通过冯·弗雷（Von Frey）的机械灵敏度评估，伤口愈合将是通过总体和组织学测定评估，将通过药代动力学评估全身毒性评估。提出的I阶段工作将证明我们的新颖持续布比卡因释放伤口敷料可以提供5天的安全有效的非阿片类镇痛，并在临床上相关的临床前模型，这将保证继续进行商业化工作。