Skin Antisepsis before Surgical Fixation of Extremity Fractures.

BACKGROUND: Studies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture). METHODS: In a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures. Every 2 months, the hospitals alternated interventions. Separate populations of patients with either open or closed fractures were enrolled and included in the analysis. The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for fracture-healing complications. RESULTS: A total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial. In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P = 0.049). In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd ratio, 0.86; 95% CI, 0.58 to 1.27; P = 0.45). The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events were similar in the two groups. CONCLUSIONS: Among patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.).

Incorporation of skin preparation guidelines in local surgical facility protocols: what kind of barriers does it face? A multi-centre study in France.

BACKGROUND: Surgical site infection (SSI) is the most frequent and severe adverse event after surgery. Among preventive measures, the preoperative skin preparation (PSP) is known to be heterogeneously implemented in routine practice. A prerequisite would be the actual incorporation of guidelines in French surgical local protocols. AIM: To assess whether PSP recommendations have been incorporated in local protocols and to identify the reasons for the non-incorporation. METHODS: An online survey was proposed to all infection control teams (ICTs) in facilities participating in the French national surveillance and prevention of SSI network Spicmi. The reference recommendations were based on the French Society for Hospital Hygiene guidelines. FINDINGS: In all, 485 healthcare facilities completed the questionnaire. The incorporation of recommendations in the facility protocol varied between 30% and 98% according to the recommendation. The measures most frequently incorporated were antisepsis with an alcoholic product and cessation of systematic hair removal. The least frequently incorporated were the use of plain soap for preoperative shower and the non-compulsory skin cleaning in the operating room. Barriers reported were either specific to PSP (e.g. 'Concern about an increase of SSI', 'Scepticism about recommendations', 'Force of habit') or non-specific (e.g. 'The protocol not yet due to be updated'). CONCLUSION: We suggest that although some major prevention measures have been incorporated in the local protocol of most facilities, local protocols still frequently include some non-evidence based former recommendations. Communication about evolution of SSI rates, diffusion of guidelines by learned societies, and exchange with judiciary experts could make clear the conditions for applying recommendations.

Biopsia en ortopedia y riesgo de contaminación bacteriana durante el muestreo de tejidos: hechos y estrategias / Biopsy in orthopaedics and risk of bacterial contamination during tissue sampling: facts and strategies

Las biopsias en el campo de la ortopedia se utilizan para guiar las opciones de diagnóstico y tratamiento para el proceso de la enfermedad que puede estar ocurriendo. La preparación de la piel de estas biopsias sigue la preparación estándar para un procedimiento quirúrgico, con el objetivo de disminuir la cantidad de microbiota que podría conducir a la contaminación del tejido de la biopsia e incluso a una posible infección. El tejido obtenido de la biopsia a menudo se somete a un studio histopatológico y cultivo. La tasa de contaminación bacteriana informada es aproximadamente inferior al 4%. Esta revisión cuestiona si las muestras de las biopsias se contaminan con la microbiota que permanece en la piel y cómo puede afectar el manejo. Además, qué técnicas o pasos pueden disminuir la tasa de contaminación al realizar una biopsia. Nuestra revisión bibliográfica identificó pocos estudios sobre la contaminación bacteriana de las biopsias. Identificamos diferentes factores implicados en el conocimiento de la microbiota de la piel: técnicas y soluciones de preparación de la piel, variación de la microbiota típica que coloniza la piel según la región anatómica, retención preoperatoria versus administración profiláctica de antibióticos y uso de diferentes hojas de bisturí para la piel superficial y para tejidos profundos, entre otros. Aunque no pudimos identificar ningún dato que proporcionara respuestas a nuestra pregunta original y cuantificar cada factor individualmente, la mayoría de los estudios en diferentes campos ortopédicos proporcionaron hallazgos significativos hasta cierto punto. Describimos algunas recomendaciones prácticas basadas en el consenso y la efectividad teórica para disminuir la tasa de contaminación. Se necesitan más investigaciones en el campo de la ortopedia que impliquen la contaminación por microbiota de la piel de una biopsia

Biopsies in the field of orthopaedics are used to guide diagnostics and treatment options for the disease process that may be occurring such as a tumor or infection. Skin preparation of these biopsies follows the standard skin preparation for a surgical procedure, with the aim to decrease the amount of microbiota that could lead to contamination of the tissue biopsy and even possible infection. The tissue obtained from the biopsy often undergoes pathology and culture. The reported bacterial contamination rate is roughly below 4%. This review questions how samples from the biopsies are getting contaminated by microbiota that remains on the skin and how it affects infection management. In addition, which techniques or steps can decrease the rate of contamination when performing a biopsy. Our review identified little to no data on investigating bacterial contamination of biopsies. In doing this, the review identified different factors implicated in skin microbiota awareness: skin preparation techniques and solutions, variation of typical microbiota that colonize the skin based on the anatomical region, preoperative withholding versus administrating antibiotics prophylactically and using different scalpel blades for superficial and deep incisions, among others. Although we failed to identify any data that provided answers to our original question and quantify each factor individually, most studies in different orthopaedic fields provided significant findings to some extent. We outline some practical recommendations based on consensus and theoretical effectiveness in decreasing the contamination rate. Further research entailing skin microbiota contamination of a biopsy is needed in the field of orthopaedics.

Best products for skin antisepsis.

BACKGROUND: Skin antiseptics are used for several purposes before surgical procedures, for bathing high-risk patients as a means of reducing central line-associated infections and other health care associated infections. METHODS: A PubMed search was performed to update the evidence on skin antiseptic products and practices. RESULTS: Current guidelines for prevention of surgical site infections (SSIs) recommend preoperative baths or showers with a plain or antimicrobial soap prior to surgery, but do not make recommendations on the timing of baths, the total number of baths needed, or about the use of chlorhexidine gluconate (CGH)-impregnated cloths. Randomized controlled trials have demonstrated that pre-operative surgical hand antisepsis using an antimicrobial soap or alcohol-based hand rub yields similar SSI rates. Other studies have reported that using an alcohol-based hand rub caused less skin irritation, was easier to use, and required shorter scrub times than using antimicrobial soap. Current SSI prevention guidelines recommend using an alcohol-containing antiseptic for surgical site infection. Commonly used products contain isopropanol combined with either CHG or with povidone-iodine. Surgical site preparation protocols for shoulder surgery in men may need to include coverage for anaerobes. Several studies suggest the need to monitor and improve surgical site preparation techniques. Daily bathing of intensive care unit (ICU) patients with a CHG-containing soap reduces the incidence of central line-associated bloodstream infections (CLABSIs). Evidence for a similar effect in non-ICU patients is mixed. Despite widespread CHG bathing of ICU patients, numerous barriers to its effective implementation exist. Measuring CHG levels on the skin is useful for identifying gaps in coverage and suboptimal skin concentrations. Using alcohol-based products with at least 2% CHG for skin preparation prior to central line insertion reduces CLABSIs. CONCLUSIONS: Progress has been made on skin antisepsis products and protocols, but improvements in technique are still needed.

Aqueous skin antisepsis before surgical fixation of open fractures (Aqueous-PREP): a multiple-period, cluster-randomised, crossover trial.

BACKGROUND: Chlorhexidine skin antisepsis is frequently recommended for most surgical procedures; however, it is unclear if these recommendations should apply to surgery involving traumatic contaminated wounds where povidone-iodine has previously been preferred. We aimed to compare the effect of aqueous 10% povidone-iodine versus aqueous 4% chlorhexidine gluconate on the risk of surgical site infection in patients who required surgery for an open fracture. METHODS: We conducted a multiple-period, cluster-randomised, crossover trial (Aqueous-PREP) at 14 hospitals in Canada, Spain, and the USA. Eligible patients were adults aged 18 years or older with an open extremity fracture treated with a surgical fixation implant. For inclusion, the open fracture required formal surgical debridement within 72 h of the injury. Participating sites were randomly assigned (1:1) to use either aqueous 10% povidone-iodine or aqueous 4% chlorhexidine gluconate immediately before surgical incision; sites then alternated between the study interventions every 2 months. Participants, health-care providers, and study personnel were aware of the treatment assignment due to the colour of the solutions. The outcome adjudicators and data analysts were masked to treatment allocation. The primary outcome was surgical site infection, guided by the 2017 US Centers for Disease Control and Prevention National Healthcare Safety Network reporting criteria, which included superficial incisional infection within 30 days or deep incisional or organ space infection within 90 days of surgery. The primary analyses followed the intention-to-treat principle and included all participants in the groups to which they were randomly assigned. This study is registered with ClinicalTrials.gov, NCT03385304. FINDINGS: Between April 8, 2018, and June 8, 2021, 3619 patients were assessed for eligibility and 1683 were enrolled and randomly assigned to povidone-iodine (n=847) or chlorhexidine gluconate (n=836). The trial's adjudication committee determined that 45 participants were ineligible, leaving 1638 participants in the primary analysis, with 828 in the povidone-iodine group and 810 in the chlorhexidine gluconate group (mean age 44·9 years [SD 18·0]; 629 [38%] were female and 1009 [62%] were male). Among 1571 participants in whom the primary outcome was known, a surgical site infection occurred in 59 (7%) of 787 participants in the povidone-iodine group and 58 (7%) of 784 in the chlorhexidine gluconate group (odds ratio 1·11, 95% CI 0·74 to 1·65; p=0·61; risk difference 0·6%, 95% CI -1·4 to 3·4). INTERPRETATION: For patients who require surgical fixation of an open fracture, either aqueous 10% povidone-iodine or aqueous 4% chlorhexidine gluconate can be selected for skin antisepsis on the basis of solution availability, patient contraindications, or product cost. These findings might also have implications for antisepsis of other traumatic wounds. FUNDING: US Department of Defense, Canadian Institutes of Health Research, McMaster University Surgical Associates, PSI Foundation.

Comparison of chlorhexidine and alcohol-based antisepsis on the paralumbar fossa in cattle.

OBJECTIVE: To determine skin reaction, post-treatment reduction (immediate effect), and 1 hour post-treatment reduction (sustained effect) of aerobic bacterial colony forming units (CFU) following three antiseptic protocols in cattle. STUDY DESIGN: Prospective, randomized experimental study. ANIMALS: Eighteen cows. METHODS: Three sites in each paralumbar fossa were clipped and randomly assigned to one of three treatment groups: 5 minute 4% chlorhexidine gluconate scrub (CHG); 90 second 80% ethanol scrub (ET); 90 second 70% isopropyl alcohol scrub (IPA). All sites were monitored at all sampling time points and at 24 hours following treatment for adverse skin reaction. Samples were collected pre-, immediately post-, and 1 hour post-treatment and plated in duplicate. Bacterial counts were shifted to eliminate zeroes, log10 transformed, and averaged. ANOVA was used to compare differences in mean reduction in log10 CFU/ml between groups. RESULTS: Reduction in log10CFU/ml was more pronounced immediately after application of IPA (p = .001) and ET (p = .001) than CHG. This reduction was better sustained after preparation with CHG than ET (p = .005) but not IPA. Immediate and sustained reductions in bacterial loads did not differ after application of IPA or ET. No adverse skin reactions were noted. CONCLUSIONS: Skin preparation with alcohol-based antiseptics was well tolerated and improved immediate bacterial reduction compared to CHG. This reduction was better sustained 1 hour after application of CHG than ET, but no difference was detected between CHG and IPA. CLINICAL RELEVANCE: Lack of adverse skin reaction and performance provide evidence to support skin preparation with alcohol-based antiseptics in cattle.

Optimizing skin antisepsis for neonatal surgery: A quality improvement initiative.

PURPOSE: Surgical site infections (SSIs) are a significant determinant of morbidity in the Neonatal Intensive Care Unit (NICU). Chlorhexidine gluconate/isopropyl alcohol (CHG-IPA) skin prep has demonstrated superiority over Povidone-Iodine (PI) in preventing SSIs in adults, however FDA labeling discourages CHG use in infants <2 months. This project aimed to i) create evidence for safe CHG skin antisepsis in neonates; and ii) evaluate the safety and effectiveness of CHG skin prep for neonatal surgery. METHODS: A literature review was conducted to assess the safety and effectiveness of neonatal CHG skin antisepsis. Following stakeholder engagement, a CHG surgical skin prep protocol and validated neonatal skin integrity tool to assess prep-associated skin injury were implemented in 50 consecutive, eligible neonates ≥1500 g and ≥34 weeks post conceptual age undergoing abdominal or thoracic surgery. SSI rates were compared to a matched, historical PI skin prep cohort. RESULTS: 2%CHG-70%IPA or 0.5%CHG-70%IPA were used based on gestational age cutoffs. None of the CHG patients experienced adverse skin prep outcomes while 8% developed SSIs, compared to 14% in the historical PI cohort. CONCLUSION: This project engaged NICU stakeholders in quality improvement work and informed the implementation of a safe and effective CHG skin prep protocol for neonatal surgery. LOE: IV.

Chlorhexidine gluconate vs povidone-iodine vaginal antisepsis for urogynecologic surgery: a randomized controlled noninferiority trial.

BACKGROUND: Although povidone-iodine (iodine) is the only Food and Drug Administration-approved vaginal antiseptic solution, there is a lack of comparative data evaluating alternatives. Chlorhexidine gluconate is readily accessible, recommended by multiple societies as an alternative for patients with iodine allergy, and preliminary data indicate that it may provide superior antisepsis. OBJECTIVE: This study aimed to compare the effectiveness of chlorhexidine and iodine as presurgical vaginal antiseptic solutions in preventing the most common surgery-associated infection after gynecologic surgery, urinary tract infections. STUDY DESIGN: We conducted a randomized controlled noninferiority trial among women undergoing urogynecologic surgery. The primary outcome measure was symptomatic urinary tract infection within 2 weeks after surgery. The secondary outcomes included culture-proven urinary tract infection at 2 and 6 weeks after surgery, symptomatic urinary tract infections at 6 weeks after surgery, any surgical site infection at 2 weeks after surgery, and patient-reported vaginal irritation after surgery. We required 58 participants per arm to demonstrate noninferiority of chlorhexidine vs iodine (margin of relative risk of <1.5 for the upper limit of 95% confidence interval) between groups for the primary outcome. RESULTS: A total of 119 participants (61 in the chlorhexidine group and 58 in the iodine group) completed the primary outcome and were included in the analyses. There was no difference in the groups' demographic characteristics, medical history, operations performed, or perioperative factors. Chlorhexidine was not inferior to iodine concerning the primary outcome, symptomatic urinary tract infection at 2 weeks after surgery (10% vs 17%; relative risk, 0.6; 95% confidence interval [-∞, 1.3]). Furthermore, chlorhexidine was not inferior to iodine for the secondary urinary tract infection outcomes (culture-proven urinary tract infection at 2 and 6 weeks after surgery and symptomatic urinary tract infection at 6 weeks after surgery). Groups were similar in terms of surgical site infection (overall 3/119 [2.5%]) and presence of any vaginal irritation (4/54 [7.4%], for both groups). CONCLUSION: Chlorhexidine was not inferior to iodine for vaginal antisepsis before urogynecologic surgery concerning urinary tract infection. Given the similar postoperative urinary tract infection rates demonstrated in this study and the lack of difference in vaginal irritation, chlorhexidine seemed to be a safe and reasonable option for vaginal antisepsis before surgical procedures. Additional studies are needed to further examine surgical site infection.

Best practice skin antisepsis for insertion of peripheral catheters.

This article discusses the importance of effective skin antisepsis prior to the insertion of peripheral intravenous catheters (PIVCs) and how best clinical practice is promoted by application of an appropriate method of skin disinfection integrated effectively with a proprietary aseptic non touch technique, or other standard aseptic technique. Historically under-reported, incidence of infection and risk to patients from PIVCs is now increasingly being recognised, with new research and evidence raising concern and helping to drive new clinical guidance and improvement. The risks posed by PIVCs are particularly significant given increasing PIVC dwell times, due to cannula removal now being determined by new guidance for clinical indication, rather than predefined time frames. Clinical 'best practice' is considered in context of the evidence base, importantly including availability and access to appropriate skin antisepsis products. In the UK, and other countries, ChloraPrep is the only skin antisepsis applicator licensed as a drug to disinfect skin and help prevent infections before invasive medical procedures, such as injections, blood sampling, insertion of PIVCs and minor or major surgery.

Alcohol (70%) versus alcoholic chlorhexidine solution (0. 5%) in skin antisepsis for neuraxial blocks: a randomized clinical trial / Álcool 70% versus solução alcoólica de clorexidina 0, 5% na antissepsia da pele para bloqueios do neuroeixo: ensaio clínico randomizado

ABSTRACT Objective: to compare the use of 0.5% alcoholic chlorhexidine and 70% alcohol in skin antisepsis for neuraxial blocks. Method: this is a non-inferiority randomized clinical trial, with two parallel arms. Seventy patients who were candidates for neuraxial block were randomly allocated to group A (n = 35), in whom antisepsis was performed with 0.5% alcoholic chlorhexidine, or to group B (n = 35), in whom we used 70% hydrated ethyl alcohol. Swabs were harvested for culture at three times: before antisepsis, two minutes after application of the antiseptic, and immediately after puncture. The samples were sown in three culture media and the number of colony forming units (CFU) per cm² was counted. Results: there was no difference between the groups regarding age, sex, body mass index, time to perform the block or type of block. There were no differences between groups in the CFU/cm² counts before antisepsis. There was less bacterial growth in group B two minutes after application of the antiseptic (p = 0.048), but there was no difference between the groups regarding the number of CFU/cm² at the end of the puncture. Conclusion: 70% alcohol was more effective in reducing the number of CFU/cm² after two minutes, and there was no difference between the two groups regarding skin colonization at the end of the procedure. These results suggest that 70% alcohol may be an option for skin antisepsis before neuraxial blocks. Trial registration: ClinicalTrials.gov, NCT02833376.

RESUMO Objetivo: comparar o uso de solução alcoólica de clorexidina 0,5% e de álcool 70% na antissepsia da pele para bloqueios do neuroeixo. Método: ensaio clínico randomizado de não inferioridade, com dois braços paralelos. Foram selecionados 70 pacientes candidatos à bloqueio do neuroeixo, randomicamente alocados para o grupo A (n=35), em que a antissepsia foi realizada com clorexidina alcoólica 0,5%, ou para o grupo B (n=35), em que se utilizou álcool etílico hidratado 70%. Foram coletadas, com swab, amostras para cultura em três momentos: antes da antissepsia, dois minutos após aplicação do antisséptico, e imediatamente após a punção. As amostras foram semeadas em três meios de cultura e foi contabilizado o número de unidades formadoras de colônias (UFC) por cm². Resultados: não houve diferença entre os grupos quanto à idade, ao sexo, ao índice de massa corporal, ao tempo para realização do bloqueio ou tipo de bloqueio. Também não houve diferenças entre os grupos na contagem de UFC/cm² antes da antissepsia. Constatou-se menor crescimento bacteriano no grupo B dois minutos após aplicação do antisséptico (p=0,048), mas não houve diferença entre os grupos quanto ao número de UFC/cm² ao final da punção. Conclusão: o álcool 70% mostrou-se mais efetivo em reduzir o número de UFC/cm² após dois minutos, e não houve diferença entre os dois grupos quanto à colonização da pele ao final do procedimento. Esses resultados sugerem que o álcool 70% pode ser opção para antissepsia da pele antes de bloqueios do neuroeixo. Registro ensaio clínico: ClinicalTrials.gov, NCT02833376.

Are three antiseptic paints needed for safe preparation of the surgical field? A prospective cohort study with 239 patients.

BACKGROUND: Preoperative skin antisepsis is an essential component of safe surgery. However, it is unclear how many antiseptic paints are needed to eliminate bacteria prior to incision. This study compared microbial skin counts after two and three antiseptic paints. METHODS: We conducted a prospective cohort study in non-emergency patients receiving a cardiac/abdominal surgery with standardized, preoperative skin antisepsis consisting of an alcoholic compound and either povidone iodine (PI) or chlorhexidine (CHX). We obtained three skin swabs from the participant's thorax/abdomen using a sterile template with a 25 cm2 window: After collection of the first swab prior to skin antisepsis, and once the second and third application of PI/CHX had dried out, we obtained a second and third swab, respectively. Our primary outcome was the reduction in microbial skin counts after two and three paints of PI/CHX. RESULTS: Among the 239 enrolled patients, there was no significant difference in the reduction of mean square root-transformed microbial skin counts with three versus two paints (P = 0.2). But distributions of colony forming units (CFUs) decreased from paint 2 to 3 in a predefined analysis (P = 0.002). There was strong evidence of an increased proportion of patients with zero CFU after paint 3 versus paint 2 (P = 0.003). We did not identify risk factors for insufficient reduction of microbial skin counts after two paints, defined as the detection of > 5 CFUs and/or ≥ 1 pathogens. CONCLUSIONS: In non-emergency surgical patients, three antiseptic paints may be superior to two paints in reducing microbial skin colonization prior to surgery.

Aqueous olanexidine versus aqueous povidone-iodine for surgical skin antisepsis on the incidence of surgical site infections after clean-contaminated surgery: a multicentre, prospective, blinded-endpoint, randomised controlled trial.

BACKGROUND: Surgical site infection (SSI) is the most common problem after surgery. Although several guidelines have indicated the efficacy of antiseptics, such as chlorhexidine-alcohol and povidone-iodine, in reducing SSI rate, the optimal recommendation is still not established. Olanexidine might have higher bactericidal activity than other antiseptic agents. However, no randomised study has evaluated the efficacy and safety of olanexidine over conventional antiseptics. We compared the effect of aqueous olanexidine and aqueous povidone-iodine on the incidence of SSI following clean-contaminated surgery. METHODS: This was a multicentre, prospective, randomised, blinded-endpoint superiority trial for surgical skin antisepsis in clean-contaminated gastrointestinal and hepatobiliary pancreatic surgeries in four Japanese hospitals. Patients aged 20 years or older who underwent elective clean-contaminated wound surgery were randomly assigned in a 1:1 replacement ratio using a computer-generated block randomisation. Patients were randomly assigned to surgical skin antisepsis with an aqueous formulation of 1·5% olanexidine or surgical skin antisepsis with an aqueous formulation of 10% povidone-iodine before surgery. We used olanexidine in a ready-to-use applicator, and povidone-iodine was administered by a brush or by compression using pliers. Both antiseptics were applied from the papilla with a cranial limit and to the upper thigh with a caudal limit. The antiseptics were allowed to dry for 3 min, and then surgery started. Participants, some investigators, and data analysts were masked to treatment allocation. Participant enrolment was done by non-masked investigators. The primary outcome was 30-day SSI assessed in the intention-to-treat population. The surgical wound site of each participant was observed daily. After discharge, participants underwent at least one outpatient visit within 30 days after surgery. This trial is registered with University hospital Medical Information Network, 000031560. FINDINGS: Between June 10, 2018, and April 18, 2019, 883 patients were assessed for eligibility. 587 patients were eligible and 294 received olanexidine and 293 received aqueous povidone-iodine before surgery. 30-day SSI occurred in 19 (7%) patients in the olanexidine group and 39 patients (13%) patients in the povidone-iodine group (adjusted risk difference -0·069; 90% CI -0·109 to -0·029; adjusted risk ratio [RR] 0·48, 90% CI 0·30 to 0·74; p=0·002). Five patients (2%) in the olanexidine group and five (2%) in the povidone-iodine group developed adverse skin reactions (adjusted RR 0·99, 95% CI 0·29 to 3·40; p=1·00). INTERPRETATION: Olanexidine significantly reduced the occurrence of overall SSI and superficial incisional SSI compared with aqueous povidone-iodine in clean-contaminated surgery. Our results indicate that olanexidine might have a role to prevent SSI in patients who undergo clean-contaminated surgeries. FUNDING: Keio University and Ohyama Health Foundation.

Bacterial skin recolonization in the operating room: comparison between various antisepsis protocols.

BACKGROUND: Surgical site infection (SSI) largely implicates the patient's endogenous skin microbiota. Perioperative disinfection protocols do not follow a general agreement. AIM: To compare antisepsis and skin protection protocols on quantitative analysis of recolonization in the operating room at regular time-steps. The study hypothesis was that one protocol would be more effective than others. METHODS: A single-centre prospective interventional study was conducted between January and June 2019. Healthy volunteers were randomized between protocols and served as their own controls. The protocols began ahead of scheduled orthopaedic surgery with a preoperative shower, mechanical cleansing, application of major antiseptics (alcoholic Bétadine™ 5% or alcoholic chlorhexidine 0.5%), sterile draping, then adhesive draping (3M™ Steri-Drape™ or iodine-impregnated 3M™ Ioban2™). Sampling was by swabbing in the operating room at 30 min intervals up to 90 min after draping. Cultures were performed under aerobic and anaerobic conditions. Qualitative and quantitative (cfu/mL) bacteriology was performed in the laboratory by direct reading on the blood agar plates. FINDINGS: Thirty subjects were included; none was lost to follow-up or excluded from analysis. Bacterial load before manipulation (T0) was significantly higher in males (P < 0.0001) despite a significantly shorter shower-to-sampling interval (P = 0.03). Smoking (P = 0.85), body mass index (P = 0.38), and depilation (P = 0.50) did not significantly affect preoperative load. Mean load increased significantly under all protocols up to T90 min, without significant superiority for any one protocol. Associated Bétadine™/Ioban™ showed the lowest T90 load, and chlorhexidine alone the highest, but without significant difference. Isolates at T0 were predominantly healthy skin commensals: coagulase-negative staphylococci, micrococci, and coryneforms. CONCLUSION: No one protocol demonstrated superiority, whether in immediate bactericidal action or in preventing skin recolonization in the operating room. Further studies are needed to define generally agreed protocols for SSI risk management.

Surgical hand rubbing versus surgical hand scrubbing: Systematic review and meta-analysis of efficacy.

BACKGROUND: Surgical hand rubbing (SHR) and surgical hand scrubbing (SHS) are two common methods used by surgeons to reduce surgical site infections. To date, the optimal method that can effectively reduce these infections remains unknown. In this study, we performed a comprehensive statistical analysis to compare the efficacy of these two methods in effectively controlling surgical site infections. METHODS: A systemic review and meta-analysis was performed by mining literature from major databases, including Pubmed, Embase, Cochrane library, Ovid and Google Scholar, and recruiting studies published between 1980 and 1st April 2019. Analysis was performed using Revman, version 5.3, software, and focused on primary outcomes that included colony-forming unit (CFU) counts and logarithmic reduction of CFU after hand antisepsis and after surgery. RESULTS: Seven clinical trials met our inclusion criteria, with a total of 764 healthcare workers analyzed. We found no statistically significant differences between the two methods with regards to CFU counts and logarithmic reduction of CFU after hand antisepsis and surgery, as well as antisepsis and surgery times. CONCLUSION: From the literature, it was evident that SHR had similar efficacy to SHS, without necessarily increasing costs. Owing to advantages such as ease of application, exposure to less dermal irritation, and less time consumption, SHR is recommended as a cost-effective alternative for management of surgical site infections.

Prepping for Prevention: An Intervention to Optimize Skin Antisepsis and Peri-Operative Antibiotic Prophylaxis.

Background: The U.S. Centers for Disease Control and Prevention recommend bathing prior to surgery, surgical skin antisepsis, peri-operative antibiotic administration, normothermia throughout the procedure, serum glucose concentration <200 mg/dL throughout the procedure, and hyperoxygenation in the immediate post-operative period to prevent surgical site infection (SSI). We developed interventions to standardize skin antisepsis and peri-operative antibiotic administration at our institution. Methods: This is a cross-sectional evaluation of surgical skin antisepsis and antibiotic administration before and after a series of interventions designed to standardize the processes. Results: One hundred twenty-four surgical skin antisepsis opportunities were observed; significant improvement was seen in hand hygiene prior to performing skin antisepsis (compliance changing from 1% to 48%; p < 0.001), sleeves being worn during skin antisepsis (1% versus 67%; p < 0.001), use of the correct cleansing time (47% versus 85%; p < 0.001), allowance for adequate drying time (67% versus 87%; p = 0.02), and use of a cleansing motion from the incision to the periphery (78% versus 95%; p = 0.004). Pre-operative antibiotic order placement, correct antibiotic selection, and optimal antibiotic dose were evaluated in 466 surgical procedures. Significant improvement was seen in both peri-operative order placement (59% versus 70%; p = 0.02) and correct antibiotic selection (52% versus 95%; p < 0.001). Conclusion: An intervention to standardize skin antisepsis and to encourage early ordering of peri-operative antibiotics was successful.

Preoperative skin antisepsis using chlorhexidine may reduce surgical wound infections in lower limb trauma surgery when compared to povidone-iodine - a prospective randomized trial.

BACKGROUND: For the prevention of surgical wound infections (SSIs), local microorganism counts can be lowered by skin antisepsis prior to surgical incisions. Until now, it has been unclear which antiseptic is the most effective. METHODS: This prospective randomized trial analyzed the efficacy of 2 frequently used agents in the reduction of postoperative wound complication rates after aseptic trauma surgery on the lower leg and foot. In the study, 279 consecutive participants were randomized; 112 received surgical skin preparations using chlorhexidine (CHX) (ChloraPrep; Becton Dickinson, Franklin Lakes, NJ) and 167 received preparations with povidone-iodine (PVP-I) (Braunoderm; B. Braun Melsungen AG, Melsungen, Germany). Primary clinical endpoints were SSIs and wound healing disorders (WHDs) within 6 months after surgery. Secondary outcome variables included demographic and perioperative risk factors for SSIs. RESULTS: Rates of WHDs and SSIs were significantly higher in the PVP-I treatment group, which experienced 9 SSIs and 12 WHDs (n = 21; 12.6%), compared to the CHX treatment group, which had 2 SSIs and 3 WHDs (n = 5; 4.5%) (P = .022). Perioperative risk factors for WHDs were obesity and longer surgery time, whereas SSIs were increased in participants with cardiovascular diseases and suction drainage. Logistic regression analysis showed that the odds of complications of wound healing were 3.5 times higher for PVP-I than for CHX (odds ratio = 3.5; 95% confidence interval, 1.1-11.2; P = .032). CONCLUSIONS: Preoperative skin antisepsis for trauma surgery of the lower leg and foot using CHX led to significantly fewer complications of wound healing when compared to PVP-I.

Pre-operative skin antisepsis with chlorhexidine gluconate baths and wipes does not prevent postoperative surgical site infection in outpatient pediatric urologic inguinal and scrotal surgery.

INTRODUCTION: To reduce surgical site infections (SSI), many institutions utilize pre-operative antisepsis with chlorhexidine gluconate (CHG) baths and/or wipes. CHG reduces bacterial colonization of the skin, but it is unclear whether this reduces SSI, and current guidelines from the American College of Surgeons, the Centers for Disease Control, and the World Health Organization do not support this practice. There are several factors that increase the risk of SSI in adults, but there is limited understanding of these factors in pediatric patients. OBJECTIVES: The primary objectives were to describe the proportion of pediatric patients undergoing hernia/hydrocele repair and/or orchiopexy who develop a postoperative (postop) SSI and to determine whether pre-operative CHG baths/wipes were associated with SSI. The secondary objectives were to identify other factors associated with SSI and to estimate the cost of CHG baths/wipes in this population. STUDY DESIGN: Pre-operative antisepsis with CHG baths/wipes was implemented at the authors institution in 2006. The authors performed a retrospective cohort study of patients aged 0-18 years undergoing hernia/hydrocele repair and/or orchiopexy by a pediatric urologist at their institution before (2004) and after (2008) the introduction of CHG. The authors compared the proportion of patients with SSI in the no CHG and CHG groups and evaluated for factors associated with SSI. Statistical analysis included Wilcoxon rank-sum test, Chi-squared test, and Fisher's exact test. The cost of CHG baths and wipes was estimated using institutional fees in 2018 US dollars. RESULTS: A total of 543 patients met inclusion criteria, 203 in the no CHG group and 340 in the CHG group. The overall rate of SSI was 0.92%. There was no association between use of CHG and SSI. No patient or peri-operative factors were associated with development of SSI. There were no CHG-associated adverse events. The cost of materials was estimated at $3.29/patient ($1118.60 for 340 cases in 2008) in 2018 US dollars. DISCUSSION: SSI is not common in pediatric patients undergoing hernia/hydrocele repair or orchiopexy. In the present study, pre-operative antisepsis with CHG baths/wipes is not associated with a reduction in SSI and carries additional cost. CONCLUSIONS: To the authors knowledge, this is the first study to evaluate the use of pre-operative antisepsis with CHG baths/wipes in an exclusively pediatric population. In the study, CHG baths/wipes add cost with no clear benefit for reducing SSI in pediatric patients undergoing hernia/hydrocele repair and/or orchiopexy.

Multicentre, open-label, randomised, controlled clinical trial comparing 2% chlorhexidine-70% isopropanol and 5% povidone iodine-69% ethanol for skin antisepsis in reducing surgical-site infection after cardiac surgery: the CLEAN 2 study protocol.

INTRODUCTION: Surgical-site infection (SSI) is the second most frequent cause of healthcare-associated infection worldwide and is associated with increased morbidity, mortality and healthcare costs. Cardiac surgery is clean surgery with low incidence of SSI, ranging from 2% to 5%, but with potentially severe consequences.Perioperative skin antisepsis with an alcohol-based antiseptic solution is recommended to prevent SSI, but the superiority of chlorhexidine (CHG)-alcohol over povidone iodine (PVI)-alcohol, the two most common alcohol-based antiseptic solutions used worldwide, is controversial. We aim to evaluate whether 2% CHG-70% isopropanol is more effective than 5% PVI-69% ethanol in reducing the incidence of reoperation after cardiac surgery. METHODS AND ANALYSIS: The CLEAN 2 study is a multicentre, open-label, randomised, controlled clinical trial of 4100 patients undergoing cardiac surgery. Patients will be randomised in 1:1 ratio to receive either 2% CHG-70% isopropanol or 5% PVI-69% ethanol for perioperative skin preparation. The primary endpoint is the proportion of patients undergoing any re-sternotomy between day 0 and day 90 after initial surgery and/or any reoperation on saphenous vein/radial artery surgical site between day 0 and day 30 after initial surgery. Data will be analysed on the intention-to-treat principle. ETHICS AND DISSEMINATION: This protocol has been approved by an independent ethics committee and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: EudraCT 2017-005169-33 and NCT03560193.

Best products for skin antisepsis.

Application of antiseptic products to the skin plays an important role in prevention of a variety of health care-associated infections. Preoperative bathing or showering is widely recommended to reduce the risk of surgical site infections. Evidence of the impact of this measure on surgical site infection rates is mixed, and further prospective trials comparing standardized protocols for showering with plain soap or chlorhexidine gluconate (CHG)-containing soap, or bathing with 2% CHG-impregnated cloths are needed to establish the most effective approach. Current evidence favors the use of alcohol-containing solutions, often containing CHG or povidone-iodine, for surgical site preparation of the skin. Preparation of vaginal mucosa prior to gynecologic surgery may be performed using either povidone-iodine or CHG. Surgical hand antisepsis can be performed by scrubbing with an antimicrobial soap or by handrubbing using an alcohol-based handrub. Addition of CHG to alcohol-based handrubs intended for surgical hand antisepsis is not necessary if they meet recommended efficacy criteria. Daily CHG bathing of intensive care unit patients has been shown to reduce a variety of health care-associated infections, most commonly bloodstream infections (BSIs). Achieving and maintaining optimum application protocols may be challenging, suggesting the need for ongoing staff education, monitoring, and feedback. Additional studies are needed to determine the impact of daily CHG bathing of non-intensive care unit patients. Alcoholic CHG is currently the preferred antiseptic for skin preparation prior to insertion of central and arterial intravascular catheters. CHG-impregnated dressings have been shown to reduce catheter-associated BSI. Because of the widespread use of antiseptics, especially CHG, surveillance for emergence of increased tolerance or resistance is warranted. Antiseptics are applied to the skin for a variety of purposes in health care. Common scenarios in which topical antiseptics are used include preoperative bathing, surgical site preparation, surgical hand hygiene, daily bathing of intensive care unit patients, and prevention of intravascular catheter-associated BSI. The purpose of this article is to review recent evidence regarding the best products for skin antisepsis.