Antiseptic efficacy of an innovative perioperative surgical skin preparation: A confirmatory FDA phase 3 analysis.

BACKGROUND: An innovative approach to perioperative antiseptic skin preparation is warranted because of potential adverse skin irritation, rare risk of serious allergic reaction, and perceived diminished clinical efficacy of current perioperative antiseptic agents. The results of a confirmatory US Food and Drug Administration (FDA) phase 3 efficacy analysis of a recently approved innovative perioperative surgical skin antiseptic agent are discussed. METHODS: The microbial skin flora on abdominal and groin sites in healthy volunteers were microbiologically sampled following randomization to either ZuraGard, a 2% chlorhexidine/70% isopropyl alcohol preparation (Chloraprep), or a control vehicle (alcohol-free ZuraGard). Mean log10 reduction of colony-forming units (CFU) was assessed at 30 seconds, 10 minutes, and 6 hours. RESULTS: For combined groin sites (1,721 paired observations) at all time points, the mean log10 CFU reductions were significantly greater in the ZuraGard group than in the Chloraprep group (P < .02). Mean log10 CFU reductions across combined abdominal and groin sites at all time points (3,277 paired observations) were significantly greater in the ZuraGard group than in the Chloraprep group (P < .02). CONCLUSIONS: A confirmatory FDA phase 3 efficacy analysis of skin antisepsis in human volunteers documented that ZuraGard was efficacious in significantly reducing the microbial burden on abdominal and groin test sites, exceeding that of Chloraprep. No significant adverse reactions were observed following the application of ZuraGard. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT02831998 and NCT02831816.

Implementation of a Wisconsin Division of Public Health Surgical Site Infection Prevention Champion Initiative.

Approximately 900 surgical site infections (SSIs) were reported to the Wisconsin Division of Public Health annually from 2013 to 2015, representing the most prevalent reported health care-associated infection in the state. Personnel at the Wisconsin Division of Public Health launched an SSI prevention initiative in May 2015 using a surgical care champion to provide surgical team peer-to-peer guidance through voluntary, nonregulatory, fee-exempt onsite visits that included presentations regarding the evidence-based surgical care bundle, tours of the OR and central processing areas, and one-on-one discussions with surgeons. The surgical care champion visited 10 facilities from August to December 2015, and at those facilities, SSIs decreased from 83 in 2015 to 47 in 2016 and the overall SSI standardized infection ratio decreased by 45% from 1.61 to 0.88 (P = .002), suggesting a statewide SSI prevention champion model can help lead to improved patient outcomes.

Evolutionary dynamics and genomic features of the Elizabethkingia anophelis 2015 to 2016 Wisconsin outbreak strain.

An atypically large outbreak of Elizabethkingia anophelis infections occurred in Wisconsin. Here we show that it was caused by a single strain with thirteen characteristic genomic regions. Strikingly, the outbreak isolates show an accelerated evolutionary rate and an atypical mutational spectrum. Six phylogenetic sub-clusters with distinctive temporal and geographic dynamics are revealed, and their last common ancestor existed approximately one year before the first recognized human infection. Unlike other E. anophelis, the outbreak strain had a disrupted DNA repair mutY gene caused by insertion of an integrative and conjugative element. This genomic change probably contributed to the high evolutionary rate of the outbreak strain and may have increased its adaptability, as many mutations in protein-coding genes occurred during the outbreak. This unique discovery of an outbreak caused by a naturally occurring mutator bacterial pathogen provides a dramatic example of the potential impact of pathogen evolutionary dynamics on infectious disease epidemiology.

Elizabethkingia anophelis: Clinical Experience of an Academic Health System in Southeastern Wisconsin.

In late 2015 and early 2016, 11 patients were identified with cultures positive for Elizabethkingia anophelis in our health system. All patients had positive blood cultures upon admission. Chart review showed that all had major comorbidities and recent health care exposure. The attributable mortality rate was 18.2%.

Carbapenem-Resistant Enterobacteriaceae Transmission in Health Care Facilities - Wisconsin, February-May 2015.

Carbapenem-resistant Enterobacteriaceae (CRE) are multidrug-resistant gram-negative bacilli that can cause infections associated with high case fatality rates, and are emerging as epidemiologically important health care-associated pathogens in the United States (1). Prevention of CRE transmission in health care settings is dependent on recognition of cases, isolation of colonized and infected patients, effective use of infection control measures, and the correct use of antibiotics. The use of molecular technologies, including polymerase chain reaction (PCR) testing, pulsed-field gel electrophoresis (PFGE), and whole genome sequencing (WGS), can lead to detection of transmission events and interruption of transmission. In Wisconsin, acute care and critical access hospitals report laboratory-identified CRE to the Wisconsin Division of Public Health (WDPH), and clinical laboratories submit CRE isolates to the Wisconsin State Laboratory of Hygiene (WSLH) for molecular testing. During February-May 2015, a total of 49 CRE isolates from 46 patients were submitted to WSLH. On June 8, WSLH informed WDPH of five carbapenemase-producing CRE isolates with closely related PFGE patterns identified among four inpatients at two hospitals in southeastern Wisconsin. An investigation revealed a high degree of genetic relatedness among the patients' isolates, but did not identify the mechanism of transmission between the two facilities. No breaches in recommended practices were identified; after reviewing respiratory care procedures, no further cases were identified. Routine hospital- and laboratory-based surveillance can detect and prevent health care transmission of CRE.

Transmission of hepatitis C virus associated with surgical procedures - New Jersey 2010 and Wisconsin 2011.

Incidents of health care-associated hepatitis C virus (HCV) transmission that resulted from breaches in injection safety and infection prevention practices have been previously documented. During 2010 and 2011, separate, unrelated, occurrences of HCV infections in New Jersey and Wisconsin associated with surgical procedures were investigated to determine sources of HCV and mechanisms of HCV transmission. Molecular analyses of HCV strains and epidemiologic investigations indicated that transmission likely resulted from breaches of infection prevention practices. Health care and public health professionals should consider health care-associated transmission when evaluating acute HCV infections.

Development and Distribution of Educational Materials for Carbapenem-Resistant Enterobacteriaceae Among Acute and Long-term Care Facilities.

INTRODUCTION: Carbapenem-resistant Enterobacteriaceae (CRE) are multidrug-resistant organisms emerging in the United States. The Wisconsin Division of Public Health implemented mandatory hospital-based CRE surveillance starting in December 2011 and assessed educational needs of health care personnel to guide education for statewide CRE prevention. METHODS: Pre- and post-intervention electronic surveys were distributed to infection control practitioners and local health departments to determine success of educational intervention. Pre-intervention telephone interviews were conducted with infection control practitioners who reported at least 1 case of CRE. RESULTS: The pre-intervention survey indicated that 20 (34%) responding infection control practitioners distributed educational materials to patients or staff and 13 (57%) responding local health departments had some CRE knowledge. A pre-intervention survey and interviews identified the need for educational materials such as fact sheets, brochures, and toolkits. Five months after materials were produced and distributed, 31 (63%) responding infection control practitioners had shared educational materials with patients or staff and 11 (100%) responding local health departments indicated some CRE knowledge. CONCLUSION: Overall, use of CRE educational material increased and improved general CRE knowledge among health care personnel following development and distribution of educational materials. Small sample size prevents determination of statistical significance between pre- and post-intervention responses.

An investigation of antibiotic susceptibility to empiric therapy for community-associated methicillin-resistant Staphylococcus aureus.

OBJECTIVE: To analyze antibiotic susceptibility patterns of community-associated methicillin-resistant Staphylococcus aureus (MRSA) isolates obtained from skin and soft tissue infections among Wisconsin outpatients. DESIGN: Retrospective genotype testing. SETTING: Isolates were forwarded to the Wisconsin State Laboratory of Hygiene and Marshfield Labs from clinical laboratories throughout Wisconsin. METHODS: MRSA isolates submitted during April, 2010-February, 2012 underwent genotype analysis using pulsed-field gel electrophoresis. Antibiotic susceptibility patterns were determined for all isolates identified by electrophoresis subtyping as strain type USA300, and pattern comparisons were made by public health region. RESULTS: Among 835 MRSA isolates submitted, 217 (26%) were genotyped. Of these, 152 (70%) were USA300 MRSA. Among the 152 USA300 isolates, 95% were susceptible to clindamycin and 99% were susceptible to tetracycline and trimethoprim-sulfamethoxazole. The proportion of clindamycin-susceptible isolates from the southern region was significantly lower when compared to the other 4 regions combined (P = 0.03). One southern region clindamycin-resistant isolate was also resistant to trimethoprim-sulfamethoxazole. CONCLUSIONS: USA300 MRSA was the predominant strain isolated from outpatient skin and soft tissue sites. Antibiotic susceptibility patterns among Wisconsin USA300 MRSA isolates are similar to patterns found in national studies. Local providers should continue to follow national practice guidelines for treatment of outpatient skin infections. A cluster of 4 clindamycin-resistant isolates and 1 trimethoprim-sulfamethoxazole resistant isolate was detected in the southern region, warranting continued surveillance for antibiotic resistance among community-associated MRSA isolates.

Prevention of Clostridium difficile infection in rural hospitals.

BACKGROUND: Prevention of Clostridium difficile infection (CDI) remains challenging across the spectrum of health care. There are limited data on prevention practices for CDI in the rural health care setting. METHODS: An electronic survey was administered to 21 rural facilities in Wisconsin, part of the Rural Wisconsin Health Cooperative. Data were collected on hospital characteristics and practices to prevent endemic CDI. RESULTS: Fifteen facilities responded (71%). Nearly all respondent facilities reported regular use of dedicated patient care items, use of gown and gloves, private patient rooms, hand hygiene, and room cleaning. Facilities in which the infection preventionist thought the support of his/her leadership to be "Very good" or "Excellent" employed significantly more CDI practices (13.3 ± 2.4 [standard deviation]) compared with infection preventionists who thought there was less support from leadership (9.8 ± 3.0, P = .033). Surveillance for CDI was highly variable. The most frequent barriers to implementation of CDI prevention practices included lack of adequate resources, lack of a physician champion, and difficulty keeping up with new recommendations. CONCLUSION: Although most rural facilities in our survey reported using evidence-based practices for prevention of CDI, surveillance practices were highly variable, and data regarding the impact of these practices on CDI rates were limited. Future efforts that correlate CDI prevention initiatives and CDI incidence will help develop evidence-based practices in these resource-limited settings.

Transmission of pandemic (H1N1) 2009 influenza to healthcare personnel in the United States.

After identification of pandemic 2009 influenza (pH1N1) in the United States, the Centers for Disease Control and Prevention (CDC) worked with state and local health officials to characterize infections among healthcare personnel (HCP). Detailed information, including likely routes of exposure, was reported for 70 HCP from 22 states. Thirty-five cases (50%) were classified as being infected in healthcare settings, 18 cases (26%) were considered to have been infected in community settings, and no definitive source was identified for 17 cases (24%). Of the 23 HCP infected by ill patients, only 20% reported using an N95 respirator or surgical mask during all encounters and more than half worked in outpatient clinics. In addition to community transmission, likely patient-to-HCP and HCP-to-HCP transmission were identified in healthcare settings, highlighting the need for comprehensive infection control strategies including administration of influenza vaccine, appropriate management of ill HCP, and adherence to infection control precautions.

Factors that influenced rates of influenza vaccination among employees of Wisconsin acute care hospitals and nursing homes during the 2005-2006 influenza season.

Hospitals and nursing homes were surveyed in 2006 to obtain information on employee influenza vaccination programs and baseline rates of influenza vaccination among employees. Results were used to make recommendations for improving employees' 2007 influenza vaccination rates. Facilities should continue to provide convenient and free vaccination programs, offer education to promote vaccination,and use signed declination forms.

Shift in Staphylococcus aureus clone linked to an infected tattoo.

A retrospective investigation of skin and soft tissue infections caused by community-associated methicillin-resistant Staphylococcus aureus (MRSA) strains among inmates in a Wisconsin correctional facility suggested a shift in MRSA genotype. Case timeline indicated a displacement of USA400 clone by USA300 clone. The USA300 index case was associated with an infected new tattoo.