The pain associated with superficial and partial-thickness dermal wounds can be intense and sustainedthroughout the healing process. Inadequate pain management can impair wound healing, prolonghospitalization, decrease patient satisfaction and increase healthcare costs. Due to limited treatment options andthe short duration of current local anesthetic formulations, opioid analgesics are the mainstay of painmanagement for these patients despite their association with a variety of adverse events. Consequently, painfrom dermal injury is not optimally treated because providers lack a safe and effective alternative to opioids fortheir patients.109 Therapeutics is developing BUPIVADERM, a novel, drug-delivering wound dressing that provides sustainedbupivacaine delivery to partial-thickness dermal wounds in a predictive and extended manner. The novel wounddressing will be a first-of-kind wound dressing that provides both the wound healing properties of the traditionalmoist wound dressings clinically available, but with the added functionality of safe and effective analgesia for 5days. The dressing will only need to be applied one time and non-traumatically peels off once re-epithelializationoccurs, thus eliminating the need for dressing changes or analgesic redosing. The novel wound dressing willprovide significant value to patients, clinicians, and society alike by increasing patient satisfaction, mitigating theuse 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 microporouspolymer films that have the same dimensions and physicochemical properties of the current gold standard moistwound dressings, but with the added ability to provide 5 days of sustained bupivacaine delivery. The proposedwork 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. Analgesicefficacy and duration will be assessed by von Frey assay of mechanical sensitivity, wound healing will beassessed via gross and histological assays, and systemic toxicity will be assessed via pharmacokineticassessment. The proposed Phase I work will demonstrate that our novel sustained bupivacaine release wounddressing can provide 5 days of safe and effective non-opioid analgesia and non-inferior wound healing in aclinically relevant pre-clinical model, which would warrant continuation of commercialization efforts.
Public Health Relevance Statement: PROJECT NARRATIVE
In this proposal, 109 Therapeutics will develop a novel, opioid-sparing anesthetic wound dressing for partial-
thickness dermal wounds (e.g., second-degree burns, skin graft donor sites, abrasion injuries). By combining
moist wound healing and extended-duration analgesia, this technology has the potential to change how pain
from dermal injury is managed. Significant value may be realized by patients, providers and society by improving
patient satisfaction, reducing opioid-related adverse events, and lowering overall costs of care.
Project Terms: Injury ; injuries ; Skin graft ; allogenic skin graft ; improved ; Site ; Area ; Surface ; Clinical ; Phase ; Histologic ; Histologically ; Epithelial ; Ventilatory Depression ; Respiratory Depression ; depressed breathing ; depression of breathing ; Withdrawal ; Opioid ; Opiates ; non-opioid analgesic ; non-narcotic analgesic ; non-opiate analgesic ; non-opioid ; non-opioid therapeutics ; nonnarcotic analgesics ; nonopiate analgesic ; nonopioid ; nonopioid analgesics ; Collaborations ; Therapeutic ; Infiltration ; Cognitive Disturbance ; Cognitive Impairment ; Cognitive decline ; Cognitive function abnormal ; Disturbance in cognition ; cognitive dysfunction ; cognitive loss ; Impaired cognition ; sedation ; Sedation procedure ; Absence of sensibility to pain ; Feels no pain ; No sensitivity to pain ; analgesia ; Absence of pain sensation ; mechanical ; Mechanics ; Hour ; Dimensions ; Clinic ; Prevent infection ; Infection prevention ; experience ; Animal Models and Related Studies ; model of animal ; model organism ; Animal Model ; Structure ; novel ; Modeling ; Property ; response ; Adverse Experience ; Adverse event ; epsilon-caprolactone ; caprolactone ; Provider ; Thickness ; Thick ; Address ; Dose ; Ph.D. ; PhD ; Doctor of Philosophy ; Preclinical Models ; Pre-Clinical Model ; in vivo ; Patient-Focused Outcomes ; Patient outcome ; Patient-Centered Outcomes ; Process ; Development ; developmental ; water vapor ; healing ; Impaired wound healing ; Impaired tissue repair ; abnormal tissue repair ; delayed wound healing ; clinically relevant ; clinical relevance ; pre-clinical research ; preclinical research ; novel therapeutics ; new drug treatments ; new drugs ; new therapeutics ; new therapy ; next generation therapeutics ; novel drug treatments ; novel drugs ; novel therapy ; addiction ; addictive disorder ; prototype ; commercialization ; FDA approved ; standard of care ; flexibility ; flexible ; Formulation ; systemic toxicity ; Skin injury ; Dermal injury ; cutaneous injury ; mechanical properties ; mechanical force ; skin wound ; cutaneous wound ; dermal wound ; experimental study ; experiment ; experimental research ; care costs ; readmission rates ; hospital re-admission rates ; hospital readmission rate ; re-admission rates ; re-hospitalization rate ; rehospitalization rate ; pain reduction ; reduce pain ; opioid sparing ; wound dressing ; wound care dressing ; infection rate ; rate of infection ; wound treatment ; treat wound ; wound management ; wound therapeutics ; wound therapy ; Wound models ; wound healing models ; second degree burn ; partial thickness burn ; Pain management ; Pain Control ; Pain Therapy ; pain treatment ; Analgesics ; Analgesic Agents ; Analgesic Drugs ; Analgesic Preparation ; Anodynes ; Antinociceptive Agents ; Antinociceptive Drugs ; pain killer ; pain medication ; pain reliever ; painkiller ; Opioid Analgesics ; opiate analgesia ; opiate analgesic ; opiate pain medication ; opiate pain reliever ; opioid analgesia ; opioid anesthetic ; opioid pain medication ; opioid pain reliever ; opioid painkiller ; Anesthetics ; Anesthestic Drugs ; Anesthetic Agents ; Anesthetic Drugs ; Local Anesthetics ; Conduction-Blocking Anesthetics ; Biocompatible Materials ; Biomaterials ; biological material ; Biological Assay ; Assay ; Bioassay ; Biologic Assays ; Biological Sciences ; Biologic Sciences ; Bioscience ; Life Sciences ; Bupivacaine ; Cicatrix ; Scars ; Constipation ; Control Groups ; Cessation of life ; Death ; Sterile coverings ; Dressing ; Gold ; Healthcare Systems ; Health Care Systems ; Recording of previous events ; History ; Hospitalization ; Hospital Admission ; Hospitals ; Mission ; Nausea ; Pain ; Painful ; Client satisfaction ; Patient Satisfaction ; Patients ; Permeability ; Drug Kinetics ; Pharmacokinetics ; Pharmacology ; Plasma ; Blood Plasma ; Plasma Serum ; Reticuloendothelial System, Serum, Plasma ; Polymers ; Research ; Resources ; Research Resources ; Safety ; Societies ; Standardization ; Family suidae ; Pigs ; Suidae ; Swine ; porcine ; suid ; Technology ; Testing ; Time ; Universities ; Utah ; Work ; wound healing ; Wound Repair ; wound resolution ; poly(lactide) ; polylactide ; Measures ; Drug Delivery Systems ; Drug Delivery ; Health Care Costs ; Health Costs ; Healthcare Costs ; Film ;
