Antimicrobial Shape Memory Polymer Foams for Rapid Hemorrhage Control and Infection Prevention in Traumatic Wounds
Abstract
Objective/Rationale: HemostatiX is the newest member of the family of shape memory polymer (SMP) foam-based medical devices for embolic applications. Shape Memory Medical, Inc., (SMM) has successfully translated TrelliX and IMPEDE foam devices for clinical use in aneurysm control and peripheral vascular occlusion based on their excellent biocompatibility and rapid blood clotting. In this proposal, a research team comprised of academic, clinical, and industrial experts from Syracuse University, SUNY Upstate Medical University, and SMM will characterize HemostatiX in animal models of noncompressible hemorrhage control and infected wounds. HemostatiX is a fully-synthetic material with natural, non-drug-based antimicrobial phenolic acids. In the long-term, HemostatiX could be stored in first-aid kits at home and on the battlefield in an easy-to-use applicator in their compressed state. They could be applied to deep, irregularly-shaped bleeds, upon which they safely expand to shape-fill the bleed site without inducing high, damaging pressures on surrounding tissues and organs. They can induce blood clotting to stabilize patients during transport to a fixed care facility. Their antimicrobial properties enable initial wound disinfection and long-term infection and biofilm prevention to improve healing outcomes. Here, we will characterize the safety and efficacy of these antimicrobial dressings in a noncompressible porcine liver injury in comparison to non-antimicrobial control SMP foams and a clinically- available hemostatic dressing. We will also evaluate infection control and would healing in a small animal model in comparison with clinical controls. FY22 DMRDP BWMIR Focus Area: This research will optimize prolonged care management of penetrating torso injury by developing solutions for prevention/management of deep space infections (e.g., bacterial or fungal) and delays in care of penetrating abdominal injury. Research and Clinical Applications, Benefits, and Risks: Uncontrolled hemorrhage is responsible for ~1.5 million deaths each year, 30-50% of which occur before getting the patient to a hospital. Current hemorrhage control strategies that employ pressure dressings and tourniquets are insufficient for noncompressible wounds (e.g., to the torso), which comprise up to 80% of bleeds. Of patients who survive the initial injury, almost half develop infections in their wounds in the first week after injury. Wound infection treatment is often complicated by biofilm formation and/or drug-resistant bacteria. An improved antimicrobial hemostatic dressing could stabilize patients en route to a fixed care facility while protecting wounds from bacteria without the need for drug- based antibiotics to which microorganisms readily develop resistance. Existing hemostatic dressings are limited by poor clotting, difficulty in application or removal, potential for internal damage from high pressures, and/or a lack of antimicrobial activity. A safe and effective antimicrobial hemostatic dressing that is easy-to-use could overcome these limitations to improve hemorrhage treatment. Projected Timeline: In year 3 of this project, we will leverage data obtained in the porcine studies to submit the control SMP foam to the FDA, leveraging prior safety and efficacy data obtained by SMM. Within 1 year of the completion of this 3-year project and upon obtaining regulatory clearance for the control foam formulation, the antimicrobial HemostatiX dressing will be submitted for regulatory clearance. We anticipate that both the control foam and the HenostatiX formulation can be made available on the market within 4 and 5 years of this proposal submission, respectively (by fall 2026 and 2027). Military and Public Benefit: This hemostatic dressing could be employed with current tourniquets to more quickly stop bleeding in extremity wounds and/or in noncompressible bleeds where tourniquet use is not appropriate. There is a signifi
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252310756
Entities
People
- Mary Beth B Monroe
Organizations
- Syracuse University
- United States Army