Assessment of the Risk and Economic Burden of Surgical Site Infection Following Colorectal Surgery Using a US Longitudinal Database: Is There a Role for Innovative Antimicrobial Wound Closure Technology to Reduce the Risk of Infection?

BACKGROUND: Colorectal surgical procedures place substantial burden on health care systems because of the high complication risk, of surgical site infections in particular. The risk of surgical site infection after colorectal surgery is one of the highest of any surgical specialty. OBJECTIVE: The purpose of this study was to determine the incidence, cost of infections after colorectal surgery, and potential economic benefit of using antimicrobial wound closure to improve patient outcomes. DESIGN: Retrospective observational cohort analysis and probabilistic cost analysis were performed. SETTINGS: The analysis utilized a database for colorectal patients in the United States between 2014 and 2018. PATIENTS: A total of 107,665 patients who underwent colorectal surgery were included in the analysis. MAIN OUTCOME MEASURES: Rate of infection was together with identified between 3 and 180 days postoperatively, infection risk factors, infection costs over 24 months postoperatively by payer type (commercial payers and Medicare), and potential costs avoided per patient by using an evidence-based innovative wound closure technology. RESULTS: Surgical site infections were diagnosed postoperatively in 23.9% of patients (4.0% superficial incisional and 19.9% deep incisional/organ space). Risk factors significantly increased risk of deep incisional/organ-space infection and included several patient comorbidities, age, payer type, and admission type. After 12 months, adjusted increased costs associated with infections ranged from $36,429 to $144,809 for commercial payers and $17,551 to $102,280 for Medicare, depending on surgical site infection type. Adjusted incremental costs continued to increase over a 24-month study period for both payers. Use of antimicrobial wound closure for colorectal surgery is projected to significantly reduce median payer costs by $809 to $1170 per patient compared with traditional wound closure. LIMITATIONS: The inherent biases associated with retrospective databases limited this study. CONCLUSIONS: Surgical site infection cost burden was found to be higher than previously reported, with payer costs escalating over a 24-month postoperative period. Cost analysis results for adopting antimicrobial wound closure aligns with previous evidence-based studies, suggesting a fiscal benefit for its use as a component of a comprehensive evidence-based surgical care bundle for reducing the risk of infection. See Video Abstract at http://links.lww.com/DCR/B358. EVALUACIÓN DEL RIESGO Y LA CARGA ECONÓMICA DE LA INFECCIÓN DEL SITIO QUIRÚRGICO DESPUÉS DE UNA CIRUGÍA COLORRECTAL UTILIZANDO UNA BASE DE DATOS LONGITUDINAL DE EE.UU.: ¿EXISTE UN PAPEL PARA LA TECNOLOGÍA INNOVADORA DE CIERRE DE HERIDAS ANTIMICROBIANAS PARA REDUCIR EL RIESGO DE INFECCIÓN?: Los procedimientos quirúrgicos colorrectales suponen una carga considerable para los sistemas de salud debido al alto riesgo de complicaciones, particularmente las infecciones del sitio quirúrgico. El riesgo de infección posoperatoria del sitio quirúrgico colorrectal es uno de los más altos de cualquier especialidad quirúrgica.El propósito de este estudio fue determinar la incidencia, el costo de las infecciones después de la cirugía colorrectal y el beneficio económico potencial del uso del cierre de la herida con antimicrobianos para mejorar los resultados de los pacientes.Análisis retrospectivo de cohorte observacional y análisis de costo probabilístico.El análisis utilizó la base de datos para pacientes colorrectales en los Estados Unidos entre 2014 y 2018.Un total de 107,665 pacientes sometidos a cirugía colorrectal.Se identificó una tasa de infección entre 3 y 180 días después de la operación, los factores de riesgo de infección, los costos de infección durante 24 meses posteriores a la operación por tipo de pagador (pagadores comerciales y Medicare), y los costos potenciales evitados por paciente utilizando una tecnología innovadora de cierre de heridas basada en evidencias.Infecciones del sitio quirúrgico, diagnosticadas postoperatoriamente en el 23,9% de los pacientes (4,0% incisional superficial y 19,9% incisional profunda / espacio orgánico). Los factores de riesgo aumentaron significativamente el riesgo de infección profunda por incisión / espacio orgánico e incluyeron comorbilidades selectivas del paciente, edad, tipo de pagador y tipo de admisión. Después de 12 meses, el aumento de los costos asociados con las infecciones varió de $ 36,429 a $ 144,809 para los pagadores comerciales y de $ 17,551 a $ 102,280 para Medicare, según el tipo de infección del sitio quirúrgico. Los costos incrementales ajustados continuaron aumentando durante un período de estudio de 24 meses para ambos pagadores. Se prevé que el uso del cierre antimicrobiano de la herida para la cirugía colorrectal reducirá significativamente los costos medios del pagador en $ 809- $ 1,170 por paciente en comparación con el cierre tradicional de la herida.Los sesgos inherentes asociados a las bases de datos retrospectivas limitaron este estudio.Se encontró que la carga del costo de la infección del sitio quirúrgico es mayor que la reportada previamente, y los costos del pagador aumentaron durante un período postoperatorio de 24 meses. Los resultados del análisis de costos para la adopción del cierre de heridas antimicrobianas se alinean con estudios previos basados en evidencia, lo que sugiere un beneficio fiscal para su uso como componente de un paquete integral de atención quirúrgica basada en evidencia para reducir el riesgo de infección. Consulte Video Resumen en http://links.lww.com/DCR/B358.

The Impact of Supplemental Intraoperative Air Decontamination on the Outcome of Total Joint Arthroplasty: A Pilot Analysis.

BACKGROUND: During the early era of arthroplasty, the concept of ultraclean operating room (OR) was introduced based on the principle that the number of airborne particles in the OR directly influences incidence of device-related infections. The hypothesis of this pilot study was that use of an innovative UV-C air decontamination technology would lead to a reduction in the incidence of periprosthetic joint infection (PJI) following total joint arthroplasty. METHODS: A retrospective, observational, surveillance study was conducted with a consecutive series of patients who underwent total joint arthroplasty (n = 496) between January 2016 and August 2017. All perioperative and postoperative care protocols were identical for both groups, only study variable was that in 231 arthroplasty patients (OR B), an innovative supplemental UV-C air decontamination technology was used, whereas in the remaining 265 patients, arthroplasty was performed with standard turbulent HVAC (OR A). RESULTS: There was no significant difference between patient groups regarding age, body mass index, diabetes diagnosis, smoking status, length of surgery, or revision status. The rate of PJI was documented to be 1.9% in the turbulent air group, and no infections were documented in the cohorts operated under UV-C air decontamination, which was statistically significant (P < .044). CONCLUSION: While PJI is multifactorial in nature, the present retrospective pilot study suggests that use of an intraoperative supplemental air decontamination significantly reduced the overall risk of PJI. The findings of this study are encouraging and should be examined in a larger-scale, prospective, multicenter study.

Clinical and microbiological aspects of biofilm-associated surgical site infections.

While microbial biofilms have been recognized as being ubiquitous in nature for the past 40 years, it has only been within the past 20 years that clinical practitioners have realized that biofilm play a significant role in both device-related and tissue-based infections. The global impact of surgical site infections (SSIs) is monumental and as many as 80 % of these infections may involve a microbial biofilm. Recent studies suggest that biofilm- producing organisms play a significant role in persistent skin and soft tissue wound infections in the postoperative surgical patient population. Biofilm, on an organizational level, allows bacteria to survive intrinsic and extrinsic defenses that would inactivate the dispersed (planktonic) bacteria. SSIs associated with biomedical implants are notoriously difficult to eradicate using antibiotic regimens that would typically be effective against the same bacteria growing under planktonic conditions. This biofilm-mediated phenomenon is characterized as antimicrobial recalcitrance, which is associated with the survival of a subset of cells including "persister" cells. The ideal method to manage a biofilm-mediated surgical site wound infection is to prevent it from occurring through rational use of antibiotic prophylaxis, adequate skin antisepsis prior to surgery and use of innovative in-situ irrigation procedures; together with antimicrobial suture technology in an effort to promote wound hygiene at the time of closure; once established, biofilm removal remains a significant clinical problem.

Surgical site infection: poor compliance with guidelines and care bundles.

Surgical site infections (SSIs) are probably the most preventable of the health care-associated infections. Despite the widespread international introduction of level I evidence-based guidelines for the prevention of SSIs, such as that of the National Institute for Clinical Excellence (NICE) in the UK and the surgical care improvement project (SCIP) of the USA, SSI rates have not measurably fallen. The care bundle approach is an accepted method of packaging best, evidence-based measures into routine care for all patients and, common to many guidelines for the prevention of SSI, includes methods for preoperative removal of hair (where appropriate), rational antibiotic prophylaxis, avoidance of perioperative hypothermia, management of perioperative blood glucose and effective skin preparation. Reasons for poor compliance with care bundles are not clear and have not matched the wide uptake and perceived benefit of the WHO 'Safe Surgery Saves Lives' checklist. Recommendations include the need for further research and continuous updating of guidelines; comprehensive surveillance, using validated definitions that facilitate benchmarking of anonymised surgeon-specific SSI rates; assurance that incorporation of checklists and care bundles has taken place; the development of effective communication strategies for all health care providers and those who commission services and comprehensive information for patients.

The effect of Surgical Care Improvement Project measures on national trends on surgical site infections in open vascular procedures.

OBJECTIVE: The Surgical Care Improvement Project (SCIP) is a national initiative to reduce surgical complications, including postoperative surgical site infection (SSI), through protocol-driven antibiotic usage. This study aimed to determine the effect SCIP guidelines have had on in-hospital SSIs after open vascular procedures. METHODS: The Nationwide Inpatient Sample (NIS) was retrospectively analyzed using International Classification of Diseases, Ninth Revision, diagnosis codes to capture SSIs in hospital patients who underwent elective carotid endarterectomy, elective open repair of an abdominal aortic aneurysm (AAA), and peripheral bypass. The pre-SCIP era was defined as 2000 to 2005 and post-SCIP was defined as 2007 to 2010. The year 2006 was excluded because this was the transition year in which the SCIP guidelines were implemented. Analysis of variance and χ(2) testing were used for statistical analysis. RESULTS: The rate of SSI in the pre-SCIP era was 2.2% compared with 2.3% for carotid endarterectomy (P = .06). For peripheral bypass, both in the pre- and post-SCIP era, infection rates were 0.1% (P = .22). For open, elective AAA, the rate of infection in the post-SCIP era increased significantly to 1.4% from 1.0% in the pre-SCIP era (P < .001). Demographics and in-hospital mortality did not differ significantly between the groups. CONCLUSIONS: Implementation of SCIP guidelines has made no significant effect on the incidence of in-hospital SSIs in open vascular operations; rather, an increase in SSI rates in open AAA repairs was observed. Patient-centered, bundled approaches to care, rather than current SCIP practices, may further decrease SSI rates in vascular patients undergoing open procedures.

A Review of the Evidence on the Role of Floors and Shoes in the Dissemination of Pathogens in a Healthcare Setting.

Background: It is generally accepted that shoes and floors are contaminated with pathogens including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and Clostridium difficile, yet correlation to clinical infection is not well established. Because floors and shoes are low-touch surfaces, these are considered non-critical surfaces for cleaning and disinfection. The purpose of this review is to assess peer-reviewed literature inclusive of floors and shoe soles as contributors to the dissemination of infectious pathogens within healthcare settings. Methods: Using the Preferred Reporting Items for Systematic Reviews (PRISMA) methodology, PubMed and Medline were searched for articles assessing the presence of pathogens on or the transmission of pathogens between or from floors or shoe soles/shoe covers. Inclusion criteria are the human population within healthcare or controlled experimental settings after 1999 and available in English. Results: Four hundred eighteen articles were screened, and 18 articles documented recovery of bacterial and viral pathogens from both floors and shoes. Seventy-two percent (13/18) of these were published after 2015, showing increased consideration of the transfer of pathogens to high-touch surfaces from shoe soles or floors during patient care. Conclusions: There is evidence that floors and shoes in healthcare settings are contaminated with several different species of health-care-associated pathogens including MRSA, VRE, and Clostridium difficile.

Microbiology of explanted suture segments from infected and noninfected surgical patients.

Sutures under selective host/environmental factors can potentiate postoperative surgical site infection (SSI). The present investigation characterized microbial recovery and biofilm formation from explanted absorbable (AB) and nonabsorbable (NAB) sutures from infected and noninfected sites. AB and NAB sutures were harvested from noninfected (70.9%) and infected (29.1%) sites in 158 patients. At explantation, devices were sonicated and processed for qualitative/quantitative bacteriology; selective sutures were processed for scanning electron microscopy (SEM). Bacteria were recovered from 85 (53.8%) explanted sites; 39 sites were noninfected, and 46 were infected. Suture recovery ranged from 11.1 to 574.6 days postinsertion. A significant difference in mean microbial recovery between noninfected (1.2 isolates) and infected (2.7 isolates) devices (P < 0.05) was noted. Staphylococcus epidermidis, Staphylococcus aureus, coagulase-negative staphylococci (CNS), Peptostreptococcus spp., Bacteroides fragilis, Escherichia coli, Enterococcus spp., Pseudomonas aeruginosa, and Serratia spp. were recovered from infected devices, while commensal skin flora was recovered from noninfected devices. No significant difference in quantitative microbial recovery between infected monofilament and multifilament sutures was noted. Biofilm was present in 100% and 66.6% of infected and noninfected devices, respectively (P < 0.042). We conclude that both monofilament and braided sutures provide a hospitable surface for microbial adherence: (i) a significant difference in microbial recovery from infected and noninfected sutures was noted, (ii) infected sutures harbored a mixed flora, including multidrug-resistant health care-associated pathogens, and (iii) a significant difference in the presence or absence of a biofilm in infected versus noninfected explanted devices was noted. Further studies to document the benefit of focused risk reduction strategies to minimize suture contamination and biofilm formation postimplantation are warranted.

Effectiveness versus Uptake: The Challenges of Implementing Evidence-Based Strategies to Reduce Surgical Site Infection in Patients with Colon Surgeries.

Background: National and international recommendations for the prevention of surgical site infection (SSI) were published six years ago, but little is known about implementation in colon surgeries. Methods: We conducted an observational study to evaluate the implementation of seven SSI-prevention elements in colon surgeries. Study coordinators recorded the implementation using an electronic case report. Surgeons completed a survey that identified key drivers of implementation. Three peer-to-peer calls and a study coordinator survey provided insights on the obstacles and drivers to implementation. Results: The elements ranged in compliance from 100% to below 1%. Absence of documentation in the electronic medical record (EMR), conflicting local policies, and a lack of standardization of processes and products were significant obstacles in implementation. Discussion: Standardizing peri-operative procedures may be accomplished by implementing guidelines. Using implementation science to reduce variability and stocking leads to product standardization with items that support evidence-based practices. Administration, material management, and surgical leadership all have a duty to the patient to reduce obstacles to implement evidence-based practices. Conclusions: Our study reveals variability in in the integration of published guidelines into clinical practice. Every surgical patient deserves the best possible care by using evidence-based guidelines and practices centered on reducing SSIs.

Risk and economic burden of surgical site infection following spinal fusion in adults.

BACKGROUND: Spinal fusion surgery (SFS) is one of the most common operations in the United States, >450,000 SFSs are performed annually, incurring annual costs >$10 billion. OBJECTIVES: We used a nationwide longitudinal database to accurately assess incidence and payments associated with management of postoperative infection following SFS. METHODS: We conducted a retrospective, observational cohort analysis of 210,019 patients undergoing SFS from 2014 to 2018 using IBM MarketScan commercial and Medicaid-Medicare databases. We assessed rates of superficial/deep incisional SSIs, from 3 to 180 days after surgery using Cox proportional hazard regression models. To evaluate adjusted payments for patients with/without SSIs, adjusted for inflation to 2019 Consumer Price Index, we used generalized linear regression models with log-link and γ distribution. RESULTS: Overall, 6.6% of patients experienced an SSI, 1.7% superficial SSIs and 4.9% deep-incisional SSIs, with a median of 44 days to presentation for superficial SSIs and 28 days for deep-incisional SSIs. Selective risk factors included surgical approach, admission type, payer, and higher comorbidity score. Postoperative incremental commercial payments for patients with superficial SSI were $20,800 at 6 months, $26,937 at 12 months, and $32,821 at 24 months; incremental payments for patients with deep-incisional SSI were $59,766 at 6 months, $74,875 at 12 months, and $93,741 at 24 months. Corresponding incremental Medicare payments for patients with superficial incisional at 6, 12, 24-months were $11,044, $17,967, and $24,096; while payments for patients with deep-infection were: $48,662, $53,757, and $73,803 at 6, 12, 24-months. CONCLUSIONS: We identified a 4.9% rate of deep infection following SFS, with substantial payer burden. The findings suggest that the implementation of robust evidence-based surgical-care bundles to mitigate postoperative SFS infection is warranted.

Longitudinal rates, risk factors, and costs of superficial and deep incisional surgical-site infection (SSI) after primary and revision total knee arthroplasty: A US retrospective claims database analysis.

OBJECTIVE: We evaluated longitudinal rates, risk factors, and costs of superficial and deep incisional surgical-site infection (SSI) 6 months after primary total knee arthroplasty (pTKA) and revision total knee arthroplasty (rTKA). METHODS: Patients were identified from January 1, 2016 through March 31, 2018, in the IBM MarketScan administrative claims databases. Kaplan-Meier survival curves evaluated time to SSI over 6 months. Cox proportional hazard models evaluated SSI risk factors. Generalized linear models estimated SSI costs up to 12 months. RESULTS: Of the 26,097 pTKA patients analyzed (mean age, 61.6 years; SD, 9.2; 61.4% female; 60.4% commercial insurance), 0.65% (95% CI, 0.56%-0.75%) presented with a deep incisional SSI and 0.82% (95% CI, 0.71%-0.93%) with a superficial incisional SSI. Also, 3,663 patients who had rTKA (mean age, 60.9 years; SD, 10.1; 60.6% female; 53.0% commercial insurance), 10.44% (95% CI, 9.36%-11.51%) presented with a deep incisional SSI and 2.60% (95% CI, 2.07%-3.13%) presented with a superficial incisional SSI. Infections were associated with male sex and multiple patient comorbidities including chronic pulmonary disease, pulmonary circulatory disorders, fluid and electrolyte disorders, malnutrition, drug abuse, and depression. Adjusted average all-cause incremental commercial cost ranged from $14,298 to $29,176 and from $41,381 to 59,491 for superficial and deep incisional SSI, respectively. CONCLUSIONS: SSI occurred most frequently following rTKA and among patients with pulmonary comorbidities and depression. The incremental costs associated with SSI following TKA were substantial.

Longitudinal Rates, Patient Risk Factors, and Economic Impact of Superficial and Deep Incisional Surgical Site Infection After Primary and Revision Total Hip Arthroplasty: A U.S. Retrospective Commercial Claims Database Analysis.

Background: Longitudinal rates, risk factors, and costs of superficial and deep incisional surgical site infection (SSI) were evaluated six months after primary total hip arthroplasty (pTHA) and revision total hip replacement (rTHA). Patients and Methods: Patients who had pTHA or rTHA between January 1, 2016 and March 31, 2018 were identified using the IBM® MarketScan® administrative claims databases. Kaplan-Meier survival curves evaluated time to SSI over six months. Cox proportional hazard models evaluated SSI risk factors. Generalized linear models estimated SSI costs up to 12 months. Results: The total cohort included 17,514 pTHA patients (mean [standard deviation] age 59.6 [10.1] years, 50.2% female; 66.4% commercial insurance), and 2,954 rTHA patients (61.2 [12.0] years, 52.0% female; 48.6% commercial insurance). Deep and superficial post-operative SSI at six months affected 0.30% (95% confidence interval [CI], 0.22%-0.39%) and 0.67% (95% CI, 0.55%-0.79% of patients in the pTHA, and 8.9% (95%CI: 7.8%-10.0%) and 4.8% (95% CI, 4.0%-5.6%) of patients in the rTHA cohorts. Hazards for SSI were related to patient comorbidities that included diabetes mellitus, obesity, renal failure, pulmonary or circulatory disorders, and depression. The adjusted average all-cause incremental commercial costs associated with post-operative infection ranged from $21,434 to $42,879 for superficial incisional SSI and $53,884 to $76,472 for deep incisional SSI, over a 12-month post-operative assessment period. Conclusions: The SSI rate after revision total hip arthroplasty (rTHA) was nearly 9% compared with 1.0% after pTHA. The risk of infection was influenced by several comorbid risk factors. The incremental cost associated with SSIs was substantial.

Prevention of Orthopedic Prosthetic Infections Using Evidence-Based Surgical Site Infection Care Bundles: A Narrative Review.

Background: The number of primary/revision total joint replacements (TJR) are expected to increase substantially with an aging population and increasing prevalence of comorbid conditions. The 30-day re-admission rate, in all orthopedic specialties, is 5.4% (range, 4.8%-6.0%). A recent publication has documented that the surgical site infection (SSI) infection rate associated with revision total knee (rTKR, 15.6%) and revision total hip (rTHR, 8.6%) arthroplasties are four to seven times the rate of the primary procedures (2.1%-2.2%). These orthopedic infections prolong hospital stays, double re-admissions, and increase healthcare costs by a factor of 300%. Methods: A search of PubMed/MEDLINE, EMBASE and the Cochrane Library publications, which reported the infection risk after TKR and THR, was undertaken (January 1, 1995 to December 31, 2021). The search also included documentation of evidence-based practices that lead to improved post-operative outcomes. Results: The evidence-based approach to reducing the risk of SSI was grouped into pre-operative, peri-operative, and post-operative periods. Surgical care bundles have existed within other surgical disciplines for more than 20 years, although their use is relatively new in peri-operative orthopedic surgical care. Pre-admission chlorhexidine gluconate (CHG) showers/cleansing, staphylococcal decolonization, maintenance of normothermia, wound irrigation, antimicrobial suture wound closure, and post-operative wound care has been shown to improve clinical outcome in randomized controlled studies and meta-analyses. Conclusions: Evidence-based infection prevention care bundles have improved clinical outcomes in all surgical disciplines. The significant post-operative morbidity, mortality, and healthcare cost, associated with SSIs after TJR can be reduced by introduction of evidence-based pre-operative, intra-operative, and post-operative interventions.

Assessment of risk and economic burden of surgical site infection (SSI) posthysterectomy using a U.S. longitudinal database.

BACKGROUND: Surgical site infection posthysterectomy has significant impact on patient morbidity, mortality, and health care costs. This study evaluates incidence, risk factors, and total payer costs of surgical site infection after hysterectomy in commercial, Medicare, and Medicaid populations using a nationwide claims database. METHODS: IBM MarketScan databases identified women having hysterectomy between 2014 and 2018. Deep-incisional/organ space (DI/OS) and superficial infections were identified over 6 months postoperatively with risk factors and direct infection-associated payments by insurance type over a 24-month postoperative period. RESULTS: Analysis identified 141,869 women; 7.8% Medicaid, 5.8% Medicare, and 3.9% commercially insured women developed deep-incisional/organ space surgical site infection, whereas 3.9% Medicaid, 3.2% Medicare, and 2.1% commercially insured women developed superficial infection within 6 months of index procedure. Deep-incisional/organ space risk factors were open approach (hazard ratio, 1.6; 95% confidence interval, 1.5-1.8) and payer type (Medicaid versus commercial [hazard ratio, 1.4; 95% confidence interval, 1.3-1.5]); superficial risk factors were payer type (Medicaid versus commercial [hazard ratio, 1.4; 95% confidence interval, 1.3-1.6]) and solid tumor without metastasis (hazard ratio, 1.4; 95% confidence interval, 1.3-1.6). Highest payments occurred with Medicare ($44,436, 95% confidence interval: $33,967-$56,422) followed by commercial ($27,140, 95% confidence interval: $25,990-$28,317) and Medicaid patients ($17,265, 95% confidence interval: $15,247-$19,426) for deep-incisional/organ space infection at 24-month posthysterectomy. CONCLUSIONS: Real-world cost of managing superficial, deep-incisional/organ space infection after hysterectomy was significantly higher than previously reported. Surgical approach, payer type, and comorbid risk factors contributed to increased risk of infection and economic burden. Medicaid patients experienced the highest risk of infection, followed by Medicare patients. The study suggests adoption of a robust evidence-based surgical care bundle to mitigate risk of surgical site infection and economic burden is warranted.

Recommendations for change in infection prevention programs and practice.

Fifty years of evolution in infection prevention and control programs have involved significant accomplishments related to clinical practices, methodologies, and technology. However, regulatory mandates, and resource and research limitations, coupled with emerging infection threats such as the COVID-19 pandemic, present considerable challenges for infection preventionists. This article provides guidance and recommendations in 14 key areas. These interventions should be considered for implementation by United States health care facilities in the near future.

Preliminary analysis of the antimicrobial activity of a novel surgical incise drape containing chlorhexidine gluconate against methicillin-resistant Staphylococcus aureus (MRSA) in an in vivo porcine, incisional-wound model.

BACKGROUND: Surgical site infections occur in at least 2%-4% of all patients. A proposed, risk-reduction strategy has been the use of adhesive, plastic incise drapes to reduce the risk of surgical site infection. The present investigation reports the efficacy of a novel chlorhexidine gluconate (CHG) adhesive surgical drape to reduce the risk of horizontal bacterial migration into surgical wounds, using a porcine model of wound contamination. METHODS: Using a standardized inoculum, and a predetermined randomization schedule, a porcine model was used to assess the efficacy of a CHG-impregnated adhesive drape to prevent MRSA contamination of a simulated surgical wound and intact skin surface compared with an iodophor-impregnated incise drape and a nonantimicrobial incise drape in 0, 1, and 4-hour surgeries. RESULTS: MRSA recovery from incisional wounds was lowest in sites treated with the CHG drape. The difference was statistically significant (P < .001) at all time points, both between the CHG drape and the nonantimicrobial control as well as between the CHG and iodophor drapes. Mean MRSA recovery from wounds treated with iodophor drapes was slightly lower than nonantimicrobial drapes. The difference was not statistically significant at 0- or 1-hour (P = .065 and P = .089, respectively), however the differences were significant at 4-hours (P = .024). DISCUSSION: These preliminary results show that a novel CHG surgical incise drape reduced MRSA contamination of a surgical incision site and showed significant antimicrobial activity against contamination of intact skin surfaces compared with an iodophor- impregnated drape. CONCLUSIONS: A novel CHG surgical drape was effective in significantly reducing MRSA contamination in an incisional wound model. Future studies are needed to assess its clinical efficacy.

Antibiotic Prophylaxis in Bariatric Surgical Procedures: Is There an Ideal Antimicrobial Agent?

When patients with significant comorbid risk factors undergo surgical procedures, they are at high risk for development of post-operative infectious complications, including surgical site infection (SSI). Obese patients characteristically fit within this risk category, and thus it is of paramount importance to establish evidence-based strategies to mitigate these infectious complications. The use of an antimicrobial prophylactic regimen is a well-established practice and is based on the principle of the "right drug, at the right time, in the right place." The subject of this article is to review the current evidence-based data on antimicrobial prophylaxis in obese patients undergoing bariatric surgical procedures.

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.

Assessment of a novel antimicrobial surface disinfectant on inert surfaces in the intensive care unit environment using ATP-bioluminesence assay.

BACKGROUND: Cross-contamination from inanimate surfaces can play a significant role in intensive care unit (ICU)-acquired colonization and infection. This study assessed an innovative isopropyl alcohol/organofunctional silane solution (IOS) to reduce microbial contamination on inert surfaces in a medical ICU. METHODS: Baseline adenosine triphosphate bioluminescence testing (ABT)-measurements (N = 200) were obtained on designated inert ICU surfaces followed by IOS treatment. At 1 and 6 weeks, selective surfaces were randomized to either IOS-treated or nontreated controls for comparison using ABT (N = 400) and RODAC colony counts (N = 400). An ABT value of ≤45 relative light units (RLU) was designated as "clean," whereas >45 was assessed as "dirty." RESULTS: Mean RLU baseline values ranged from 870.3 (computer keyboard) to 201.6 (bed table), and 97.5% of surfaces were assessed as "dirty." At 6 weeks, the mean RLU of surfaces treated with IOS ranged from 31.7 (physician workstation) to 51.5 (telephone handpiece), whereas values on comparative control surfaces were 717.3 and 643.7, respectively (P < .001). Some 95.5% of RODAC cultures from IOS-treated sites at 6 weeks were negative, whereas 90.5% of nontreated sites were culture-positive, yielding multiple isolates including multidrug-resistant gram-positive and gram-negative bacteria. CONCLUSIONS: IOS-treated surfaces recorded significantly lower RLU and RODAC colony counts compared with controls (P < .001). A single application of IOS resulted in a persistent antimicrobial activity on inert ICU surfaces over the 6-week study interval.