Silicone roll-on prosthetic liners are widely used by lower limb amputees. Most patients, however complain of skin-related issues due to the warm, moist environment. The long term goal of this SBIR project is to develop and commercialize a vastly improved silicone prosthetic liner with antimicrobial properties so as to improve hygiene and greatly reduce risk of infection from dangerous pathogens. Phase I specific aims will establish proof of concept by demonstrating produceability of polysiloxane material that exhibits potent biocidal function, with negligible impact on mechanical performance. Polysiloxane formulation and halogenation will be mathematically optimized for antimicrobial effectiveness vs. material properties. Mechanical performance will be assessed using ATSM F22042-00(2011) guidelines recommended for silicone elastomers used in medical applications. In addition, we will confirm stability and rechargeability of the material by verifying that no halogen leaching occurs in simulated sweat environments, and antimicrobial potency can be regained by wiping dilute hypochlorite solution if halogenation is discharged. Skin compatibility will be confirmed using the Draize Skin Test performed by the University of South Dakota Animal Resources Center.
Public Health Relevance Statement: Public Health Relevance: The long-term goal of this project is commercialization of a safe and effective antimicrobial silicone prosthetic liner useful for patients with limb amputation for lowering infection risk, eliminating offensive odors, and improving patient well-being.
NIH Spending Category: Assistive Technology; Bioengineering; Infectious Diseases; Rehabilitation
Project Terms: Acids; Address; Adhesions; Amputees; animal resource; antimicrobial; Bacteria; Bacterial Infections; base; biomaterial compatibility; Biomedical Engineering; Calcium Carbonate; Chelating Agents; commercialization; cost; cost effective; crosslink; Development; Drug Formulations; Effectiveness; Elastomers; Environment; Exhibits; fungus; Goals; Growth; Guidelines; halogenation; Halogens; Health; Household; Hydantoins; Hygiene; Hypersensitivity skin testing; Hypochlorite; improved; Infection; Influentials; Ions; Lead; Life; limb amputation; Limb Prosthesis; Lower Extremity; Manufacturer Name; Mechanics; Medical; medical specialties; meetings; metal chelator; Molecular Weight; Motion; nanoparticle; Necrosis; novel; Odors; Orthotic Medical Specialty; Particle Size; pathogen; Patients; Performance; Personal Satisfaction; Phase; Polymers; Problem Solving; Process; Production; programs; Property; Prosthesis; public health relevance; Relative (related person); Reporting; residual limb; Risk; Silicone Elastomers; Silicones; Siloxanes; Silver; Skin; Small Business Innovation Research Grant; Solutions; South Dakota; Sweat; Sweating; Technology; Textiles; Tissues; Toxic effect; United States National Institutes of Health; Universities; Validation; Virus; water treatment
