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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.

项目摘要与浅表和部分皮肤层伤口相关的疼痛可能是强烈和持续的在整个愈合过程中。疼痛管理不当会损害伤口愈合，延长住院、降低患者满意度和增加医疗保健成本。由于有限的治疗选择和目前的局部麻醉制剂持续时间短，阿片类镇痛药是疼痛的主要药物尽管这些患者与各种不良事件相关，但仍需要对这些患者进行管理。因此，疼痛由于提供者缺乏安全有效的阿片类药物替代品，他们的病人 109 Therapeutics正在开发BUPIVADERM，这是一种新型的药物输送伤口敷料，可提供持续的布比卡因以预测和延长的方式递送至部分厚度的皮肤伤口。新伤口敷料将是第一种伤口敷料，湿性伤口敷料临床可用，但增加了安全有效的镇痛功能，天该敷料仅需使用一次，一旦上皮再形成，即可无创剥离因此无需更换敷料或重新给药止痛剂。该新型伤口敷料将通过提高患者满意度，减轻患者的痛苦，为患者，临床医生和社会提供重要价值。阿片类药物的使用，以及降低部分皮层皮肤伤口治疗的护理成本。在初步的实验中，我们已经证明了制造布比卡因负载的微孔聚合物薄膜具有与当前金标准湿膜相同的尺寸和物理化学性质伤口敷料，但具有提供5天持续布比卡因递送的额外能力。拟议工作将寻求通过验证安全性来证明新型伤口敷料的体内技术可行性，我们的原型在标准化猪皮肤损伤模型中的伤口愈合和镇痛功效。镇痛将通过机械敏感性的von Frey测定来评估疗效和持续时间，通过大体和组织学试验评估，全身毒性将通过药代动力学评估考核拟议的第一阶段工作将证明我们的新的持续布比卡因释放伤口敷料可提供5天安全有效的非阿片类镇痛和非劣效性伤口愈合，临床相关的临床前模型，这将保证继续商业化的努力。