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Transmission of organisms by contact of gloves with surfaces following contact with a pathogen source has been recognized as an important vector for pathogenesis of health care-associated infections. In these cases, the gloves protect the wearer from contact with the pathogenic organisms; however, this personal protection can facilitate the wearer unwittingly becoming a carrier of the pathogens from one location to another. A novel gendine (combination of chlorhexidine and gentian violet) antiseptic coating for the external surface of the glove was developed as a potential intervention to prevent this mode of transmission.
Methods
We characterized the ability of the coating to rapidly kill bacterial and fungal pathogens within 1 minute of contact with the glove surface. The International Organization of Standardization 22196 concentrated inoculum contact testing methodology was followed.
Results
The gendine-coated gloves were able to fully eradicate multidrug-resistant organisms included methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterocci, multidrug-resistant Pseudomonas aeruginosa, and Klebsiella pneumoniae carbapenemase producing. In addition, Candida albicans, Candida glabarata, and 2 pathogenic Escherichia coli strains commonly associated with invasive gastroenteritis were also fully eradicated within 1 minute of contact. The gendine coating did not adversely impact the finish or integrity of the disposable gloves.
Conclusion
The highly efficacious gendine-coated antimicrobial gloves potentially provide an additional means of protection against horizontal transmission of common pathogens in a hospital setting.
Health care-associated infections (HAIs) are one of the major causes of morbidity and mortality in the United States. An estimated 1.7 million HAIs will occur annually resulting in approximately 99,000 attributable deaths and medical costs of over $25 billion.
Scott R. The direct medical costs of healthcare-associated infections in US hospitals and the benefits of prevention. Available from: http://www.cdc.gov/HAI/pdfs/Scott_CostPaper. March 2009. Accessed January 5, 2013.
Multidrug-resistant (MDR) pathogens including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE), and more recently emerging pan-resistant gram-negative pathogens have been identified as the causative agents for HAI, necessitating increased surveillance.
Antimicrobial-resistant pathogens associated with healthcare-associated infections: summary of data reported to the National Healthcare Safety Network at the Centers for Disease Control and Prevention, 2009-2010.
As of 2011, 22 states and Washington, DC, are now required to report HAI to the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network, and several other states are considering similar mandates.
Center for Disease Control and Prevention, National Center for Emerging and Zoonotic Infections, Division of Healthcare Quality Promotion. National and State Healthcare-associated infections standardized infection ratio report: using data reported to National Healthcare Safety Network. January 2010-December 2010. Available from: http://www.cdc.gov/hai/pdfs/SIR/national-SIR-Report_03_29_2012.pdf. Accessed February 28, 2013.
Furthermore, increased costs associated with HAIs have prompted a change in insurance payouts to the hospital. In 2009, Medicare ceased to pay for preventable adverse events including HAIs.
Increasing incidence, attributable comorbidities, and costs associated with HAI has created a demand for an additional means for prevention.
Almost half (50%) of reported HAI are attributable to cross infection from transmission of pathogens via hands of health care personnel because of either inadequate and improper gloving or hand hygiene or personnel coming into contact with contaminated fomites such as bed rails or other surfaces in the patients environment.
transmission from HCWs coming into contact with contaminated fomites in the patient environment are beginning to play a significant role in transmission of infections caused by VRE, Clostridium difficile, and resistant gram-negative pathogens.
Role of hospital surfaces in the transmission of emerging health care-associated pathogens: norovirus, Clostridium difficile, and Acinetobacter species.
Guideline for hand hygiene in health-care settings: recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Society for Healthcare Epidemiology of America/Association for Professionals in Infection Control/Infectious Diseases Society of America.
which is a major focus of some public health and infection control programs. These guidelines are easily accessible to physicians and HCWs, as well as to the general public
Gloving has been shown to reduce transmission; however, prolonged use of gloves often creates a “second skin,” increasing risk for transmission despite the gloving intervention.
Improper gloving and hand hygiene can lead to cross contamination and horizontal spread of pathogens that can result in increased incidence of HAIs, increased microbial resistance, and serious complications.
The need for improved means for prevention in addition to gloving and proper hand hygiene in a hospital setting is apparent. Here, we report on the potential of a novel glove antimicrobial coating to rapidly kill a broad spectrum of infectious pathogens upon surface contact. The antimicrobial glove treatment consists of both of a novel antiseptic combination (mixture of gentian violet and chlorhexidine called gendine) as well as a novel polymeric coating that is suitable for the high-speed aqueous processes used in disposable glove manufacturing.
Methods
Glove coating
Partially hydrolyzed polyvinyl acetate (approximately 85% hydrolyzed) and gelatin were fully dissolved in 20% (wt/vol) aqueous gendine at concentrations of approximately 1% (wt/vol). All coating reagents were purchased from Sigma Aldrich (St Louis, IL). Sensicare disposable nitrile gloves (Medline Industries, Mundeleine, IL) were coated on the external surfaces by pulling over a mandrel and then dipping into the coating solution for a few seconds. Following retraction of the glove-mandrel assembly, excess coating solution was allowed to drip off, and then the coated glove was dried by exposing to gentle hot air convection for about 1 minute. The coated gloves were cut into smaller film segments for antimicrobial efficacy testing.
Antimicrobial efficacy testing
The ability of gendine-coated gloves to prevent microbial transmission was evaluated at 1-minute contact durations with microbial challenge inocula. Testing was performed in triplicate for each challenge organism (separate coated glove for each test) following the method described in International Organization of Standardization (ISO) 22196 (International Standard Method for evaluating antimicrobial efficacy of antibacterial coating on plastic surfaces).
Briefly, 4-cm2 films were cut from coated gloves and secured over the opening of a 50-mL centrifuge tube to ensure that the surface of the glove was flat, and the surface was exposed to 1.0 × 106 colony-forming units (CFU) of 13 different gram-positive, gram-negative, and yeast organisms. A microscope coverslip was placed on top of the bacterial inoculum to ensure that a uniform thin film of inoculum would be evaluated. After exposure, all antimicrobial activity was halted by submersion in 10 mL of D/E Neutralizing Broth (Becton Dickinson, Sparks, MD). Subsequent culture was recovered and serially diluted for quantitative culture.
As a comparator, uncoated control gloves were also tested (in triplicate) following 1-minute exposures to challenge inocula, and the viable organisms recovered were quantified. By comparing the number of organisms recovered from the control gloves to the number organisms recovered from the gendine antimicrobial gloves, a log10 reduction produced by the gendine gloves was calculated.
Thirteen gram-positive, gram-negative, and yeast isolates (Table 1) were tested. Of the 13 isolates, 7 were MDR clinical isolates from cancer patients from our hospital. MDR organisms included MRSA, VRE, MDR Pseudomonas aeruginosa, and Klebsiella pneumoniae carbapenemase producing. Four isolates were standard American Type Culture Collection strains identified in ISO 22196 for evaluating antimicrobial efficacy, and 2 were pathogenic Escherichia coli strains (Shiga toxin-producing E coli, STEC and enterotoxigenic E coli, ETEC) commonly associated with invasive gastroenteritis.
Table 1Organisms used to evaluate antimicrobial efficacy of gendine antimicrobial gloves
To confirm the ability of D/E Neutralizing Broth (Becton Dickinson) to completely neutralize the gendine antimicrobial coating applied to glove surfaces, a neutralization assay was conducted. The test was conducted as described above in the ISO method; however, prior to exposure to the challenge inoculum, the gendine-coated glove film was submerged in D/E Neutralizing Broth (Becton Dickinson) for 1 minute. This was done to assess neutralization of all antimicrobial activity on the surface of the glove film prior to bacterial exposure. The film was then removed and exposed to 1.0 × 106 CFU of bacterial MRSA inoculum for 1 minute, and viable organisms were recovered and enumerated as described above. Recovered organisms from the neutralized antimicrobial glove were compared with the amount of recovered organisms from an uncoated control glove. This verified that the D/E Neutralizing Broth completely neutralized the antimicrobial activity in the gendine coating because there was no difference in the number of organisms recovered from a control uncoated glove.
Statistical analysis
Wilcoxon rank-sum tests were used for the comparisons. All tests were 2-sided, and statistical significance was set at P ≤ .05. The statistical analyses were performed using SAS software version 9.1 (SAS Institute, Cary, NC).
Results
Antimicrobial efficacy testing
Compared with uncoated control glove films, gendine-coated nitrile glove films demonstrated a significant (P = .02 for all organisms tested) reduction of at least >5 log10 for the bacterial pathogens (see Fig 1 for gram-positive organism results and Fig 2 for gram-negative organism results). There was a >4-log10 reduction for all 3 yeast organisms (Fig 3). For MDR pathogens associated with HAIs, within 1 minute gendine gloves showed close to a 6-log10 reduction for Klebsiella pneumonia carbapenase-producing bacteria, a 5.7-log10 reduction for P aeruginosa, and a 5.6-log10 reduction for MRSA. In addition, gendine-coated gloves completely killed all organisms within 1 minute of contact.
Fig 1Efficacy of antimicrobial gendine nitrile gloves tested for 1-minute exposure to multidrug-resistant clinical (MRSA, VRE) and standardized American Type Culture Collection (ATCC) (S aureus 6538) gram-positive organisms.
Fig 2Efficacy of antimicrobial gendine nitrile gloves tested for 1-minute exposure to (A) multidrug-resistant clinical and (B) pathogenic E coli and standardized ATCC gram-negative organisms.
Gendine-coated glove films that were neutralized with D/E Neutralizing Broth prior to exposure to MRSA showed a <1-log10 difference in bacterial recovery when compared with uncoated control glove films (neutralized gendine: 1.85 × 105 CFU, control uncoated: 6.7 × 105 CFU). Results confirm that antiseptic activity halted upon introduction of D/E Neutralizing Broth and that there is no residual kill, thus indicating that gendine-coated gloves kill within the 1-minute testing period.
Discussion
Gendine antimicrobial gloves killed a broad spectrum of gram-positive, gram-negative, and yeast organisms within 1 minute. The organisms tested are representative of common and emerging MDR pathogens that account for the majority of hospital-acquired infections. This includes organisms such as MRSA, which is considered to be endemic in many hospitals and the emerging pan-resistant, gram-negative pathogen carbapenase-producing Klebsiella that is quickly becoming a major health care threat. Complete kill by gendine gloves within 1 minute is highly relevant to a clinical setting where a recent prospective clinical trial showed significantly increased risk of horizontal transfer of MDR bacteria in intensive care units with exposures greater than 5 minutes in duration.
Guideline for hand hygiene in health-care settings: recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Society for Healthcare Epidemiology of America/Association for Professionals in Infection Control/Infectious Diseases Society of America.
These guidelines are not only available to doctors and other health care personnel but have been adapted and published to educate the general public about the importance of handwashing. Despite these guidelines and education materials, hand hygiene compliance among HCWs has been inconsistent and varied.
Furthermore, it has been shown that patients and family members are reluctant to advocate for themselves if HCWs are noncomplaint with hand hygiene procedures.
Prolonged use of gloves, which might best protect HCWs from pathogenic threats, provides an ideal surface for pathogens to multiply on and thus increases the potential for breakthrough transmission and hospital-acquired infection.
A few attempts have been made to develop and assess the efficacy of antimicrobial gloves. Some have been based on antimicrobial powders, which are no longer are used in donning gloves. Barza
developed antimicrobial gloves activated by light or water to release chlorine dioxide (ClO2). The author demonstrated a 2.4-log10 reduction of S aureus within 45 minutes of exposure.
Criticism of these gloves focused on the incomplete eradication of organisms that contacted the glove surface, the long time to accomplish this, and the toxicity of chlorine dioxide.
Another study developed antimicrobial gloves with a chlorhexidine gluconate-releasing matrix on the inside surface of the glove designed to provide protection to the HCW from contaminated fluids that might penetrate the glove barrier from accidental rupture or needlestick
but was not designed to prevent horizontal transmission because the external surface of the glove was untreated. Despite efforts such as these, no antimicrobial glove geared toward reducing horizontal transmission has gained widespread clinical adoption. In a previous paper, our group developed a prototype disposable antimicrobial glove to prevent horizontal transmission using an organic solvent-based process and a different antiseptic combination (mixture of brilliant green and chlorhexidine called gardine
). These first prototype antimicrobial gloves showed microbial kill within 1 minute for common hospital-acquired pathogens including MRSA, VRE, and E coli and thereby demonstrated the potential for impregnated antimicrobial gloves to prevent horizontal transmission of pathogens in clinical environments. The gardine antiseptic was directly impregnated into the nitrile comprising the glove; however, it required the use of organic solvents, which impacted the physical finish and integrity of the gloves. Substitution of gentian violet for brilliant green enabled a water-based fabrication process that would be lower cost and more environmentally benign. Furthermore, the surface integrity of the gendine glove was not compromised by the use of organic solvents, and the polymer in the gendine-coating solution allowed the coated glove to preserve a smooth tactile feel while maintaining continuity of protection of the antimicrobial surface regardless of whether the glove had been stretched. Polymers other than partially hydrolyzed polyvinyl acetate examined during development were able to form a coating on disposable glove surfaces; however, they delaminated once subjected to strains from manual manipulation of fingers of the glove.
The antiseptic properties of gentian violet are widely accepted as a treatment for oral thrush (Candidiasis) and historically have been used topically to treat fungal dermatitis and impetigo.
Chlorhexidine is also a widely used antiseptic that is found in many different medical applications. In 2002 CDC/Infectious Disease Society of America guidelines for prevention of catheter-related bloodstream infection were modified to include chlorhexidine gluconate as the preferred method of skin antisepsis during catheter placement and management.
Subsequently, a trial by Darouiche et al showed a significant reduction in the rate of surgical site infections with the use of chlorhexidine gluconate compared to povidone iodine in skin antisepsis.
Several studies have been conducted on other medical devices made with different plastics that demonstrate that gendine treatment is also highly effective in reducing biofilm colonization on a wide range of medical devices. These include polyurethane central venous catheters,
Gendine treatment of these devices was performed with organic solvent-based processes and focused on preventing microbial colonization of the device surfaces over a period of weeks. In contrast, disposable gloves are normally discarded the day of use, and the glove application demands that organisms that contact the glove surface be rapidly killed within 1 minute of contact.
Further studies need to be conducted in a patient care setting to confirm anticipated antimicrobial efficacy in actual use. Further studies are also needed to assess the efficacy of gendine antimicrobial gloves against viruses such as HIV and hepatitis. The components in the gendine coating are all inexpensive and commercially available in medical purities in bulk quantities. The aqueous coating process is expected to only modestly add to glove cost. An economic assessment is still needed to demonstrate favorable cost-benefit. Nevertheless, disposable gendine gloves could be a meaningful addition to already established infection control measures and represent an additional means to halt the horizontal transmission of invasive microbial pathogens in health care settings.
References
Scott R. The direct medical costs of healthcare-associated infections in US hospitals and the benefits of prevention. Available from: http://www.cdc.gov/HAI/pdfs/Scott_CostPaper. March 2009. Accessed January 5, 2013.
Antimicrobial-resistant pathogens associated with healthcare-associated infections: summary of data reported to the National Healthcare Safety Network at the Centers for Disease Control and Prevention, 2009-2010.
Center for Disease Control and Prevention, National Center for Emerging and Zoonotic Infections, Division of Healthcare Quality Promotion. National and State Healthcare-associated infections standardized infection ratio report: using data reported to National Healthcare Safety Network. January 2010-December 2010. Available from: http://www.cdc.gov/hai/pdfs/SIR/national-SIR-Report_03_29_2012.pdf. Accessed February 28, 2013.
Role of hospital surfaces in the transmission of emerging health care-associated pathogens: norovirus, Clostridium difficile, and Acinetobacter species.
Guideline for hand hygiene in health-care settings: recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Society for Healthcare Epidemiology of America/Association for Professionals in Infection Control/Infectious Diseases Society of America.
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