Novel Protective Underglove
Condition: Bacterial Diseases
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Underglove coating (skin barrier)
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Underglove, polyvinylidene fluoride, acrylic polymer