Bacterial Diseases Clinical Trial
Official title:
Novel Protective Underglove
Bloodborne pathogens are infectious bacteria, viruses, or other disease-causing germs carried in blood or other body fluids. These germs include hepatitis B and C viruses and HIV. Surgical and examination gloves are worn by health care workers to reduce the risk of workers catching germs from patients or patients catching germs from workers. The purpose of this study is to further develop polyvinylidene fluoride coatings for use as a protective coating worn underneath the gloves. Some health care workers may have tiny cuts on their hands that need to be protected, and gloves can have defects such as tiny holes that can allow germs to travel through them. The undercoating can add an additional layer of protection under gloves. The coating is applied in liquid form to hands and dries as a film without wrinkling, tearing, lifting, or bubbling. The liquid contains chemicals that fight germs. The coating also provides protection from skin irritation caused by the latex in some gloves.
The goal of this project is to complete development of a unique thin film technology to be used as a skin barrier underneath surgical and examination gloves. The technology, which is antimicrobial upon application to skin, has been developed to reduce transmission of bacteria and bloodborne pathogens, and is expected to protect skin from the detrimental effects of chronic glove occlusion and hand washing. Due to the increased prevalence of human immunodeficiency virus (HIV) and hepatitis, the efficacy of surgical and examination gloves has become an important safety issue, especially for health care workers where occupational exposure to pathogens in blood or other body fluids is common. Transmission can occur from both caregiver to patient, and from patient to caregiver. However, glove leaks are frequent and the potential for pathogen transmission is of great concern. In addition, as awareness of the hazards from bloodborne pathogen transmission increased along with AIDS awareness in the 1990s, the concomitant increased use of disposable gloves has adversely affected skin condition, causing increased cumulative irritation contact dermatitis and heightened dermal sensitization to natural rubber latex. This unique thin film technology is a blend of polyvinylidene fluoride (PVDF) and acrylic polymers that forms thin membrane coatings that provide a tough, flexible barrier to liquids, yet have a "breathable" microporous structure. PVDF-based coatings are applied as a fast drying liquid solution that casts an adherent contiguous film directly on the skin upon drying. The liquid solution is antimicrobial on contact, and after drying, the coatings are durable, resistant to penetration by pathogens, and stay intact for 8 hours or longer. Phase I studies established the feasibility of using the PVDF technology as a protective barrier to be worn underneath gloves. The Phase I studies focused on exploiting the coating's inherent hydrophobicity to create a barrier to bacterial and viral penetration while maintaining breathability and comfort. The coatings demonstrated barrier function to viral and bacterial pathogens in vitro, proved to be safe in animal safety studies, and were shown to be a barrier to liquid in human trials. Phase II studies will complete the development of the PVDF technology for use as a novel protective underglove. The following aims have been designed to demonstrate safety and efficacy of the product and to satisfy Food and Drug Administration (FDA) requirements: implement Good Manufacturing Practices (GMP) and establish packaging; evaluate coating formulations in human subjects for effects on skin physiology; and demonstrate safety of coatings in human studies. A skin coating to be worn under gloves that is antimicrobial on contact, provides a barrier to bloodborne and bacterial pathogens, is a barrier to latex proteins, and could improve skin conditions on hands, would be beneficial to healthcare in the workplace and likewise have significant commercial potential. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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