Prostate biopsy sepsis prevention: external validation of an alcohol needle washing protocol.

PURPOSE: Transrectal ultrasound-guided prostate biopsy (TRUS-Bx) is associated with a 1-8% risk of post-biopsy sepsis (PBS). A recent study described an isopropyl alcohol needle washing protocol that significantly decreased PBS rates. The current study examined the efficacy of this technique in our clinic population. MATERIALS AND METHODS: Data were reviewed for 1250 consecutive patients undergoing TRUS-Bx at the Charlie Norwood VA Medical Center from January 2017 to January 2023. Needle washing was adopted in February 2021. Complications occurring within 30 days after TRUS-Bx were recorded. RESULTS: There were 912 patients in group 1 (without needle washing) and 338 in group 2 (with needle washing). Groups had equivalent demographic features, and men of African descent comprised 70% of patients. Standard 12 core biopsies were done in 83% and 82% in groups 1 and 2, respectively (p = 0.788). Total complication rates were 4% and 2% in groups 1 and 2, respectively (p = 0.077). There were 13 sepsis events in group 1 (1.4%) and none in group 2 (p = 0.027). Clavien-Dindo Grade I-III complications occurred in 25 (2.7%) and 7 (2.1%) patients in groups 1 and 2, respectively (p = 0.505). Standard antibiotic prophylaxis (PO fluoroquinolone and IM gentamicin) was given in 80% and 86% of patients in groups 1 and 2, respectively (p = 0.030). Subset analysis limited to patients who received standard prophylaxis showed a significant difference in sepsis rates (1.5% vs 0%; p = 0.036). CONCLUSIONS: Adoption of isopropyl alcohol needle washing was associated with a significant decrease in PBS events.

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.).

Review & meta-analysis: isopropanolic black cohosh extract iCR for menopausal symptoms - an update on the evidence.

A systematic literature search revealed 35 clinical studies and one meta-analysis comprising 43,759 women, of which 13,096 were treated with isopropanolic Cimicifuga racemosa extract (iCR). Compared to placebo, iCR was significantly superior for treating neurovegetative and psychological menopausal symptoms, with a standardized mean difference of -0.694 in favor of iCR (p < 0.0001). Effect sizes were larger when higher dosages of iCR as monotherapy or in combination with St. John's wort (Hypericum perforatum [HP]) were given (-1.020 and -0.999, respectively), suggesting a dose-dependency. For psychological symptoms, the iCR+HP combination was superior to iCR monotherapy. Efficacy of iCR was comparable to low-dose transdermal estradiol or tibolone. Yet, due to its better tolerability, iCR had a significantly better benefit-risk profile than tibolone. Treatment with iCR/iCR+HP was well tolerated with few minor adverse events, with a frequency comparable to placebo. The clinical data did not reveal any evidence of hepatotoxicity. Hormone levels remained unchanged and estrogen-sensitive tissues (e.g. breast, endometrium) were unaffected by iCR treatment. As benefits clearly outweigh risks, iCR/iCR+HP should be recommended as an evidence-based treatment option for natural climacteric symptoms. With its good safety profile in general and at estrogen-sensitive organs, iCR as a non-hormonal herbal therapy can also be used in patients with hormone-dependent diseases who suffer from iatrogenic climacteric symptoms.

Isopropyl alcohol nasal inhalation for nausea in the triage of an adult emergency department.

OBJECTIVES: Nausea and vomiting (N&V) are among the most common complaints in the emergency department (ED). However, low acuity is assigned to most of these patients at the triage, and waiting for long hours without medication decreases patient safety and satisfaction. We aimed to compare the inhalation of isopropyl alcohol (IPA) with placebo (P) to treat nausea at the triage area of an ED. METHODS: In this prospective, randomized and placebo-controlled trial, we used a convenience sample of consecutive adult (ages 18-65) patients presented to the triage area of the ED with the complaint of N&V, and we randomized them to inhale IPA or P embedded gauzes. We used an 11-point (0-10) numeric rating scale (NRS) to evaluate the degree of N&V before the inhalation, at the baseline, and at 2, 4 and 10 min after the inhalation. RESULTS: We randomized 118 patients (IPA, n = 62; P, n = 56, intent-to-treat), three patients left the ED without being seen, and 115 patients completed the study. IPA and P groups were similar according to age, sex, comorbidities, and vital signs. We found that patients in the IPA group had significantly lower mean NRS starting with the 2nd minute (robust two-way mixed ANOVA between-subjects, p = 0.008). We also observed a significant within-subjects effect in the IPA group. The mean NRS value was decreased at each consecutive time point in the IPA group (all pairwise comparisons, p < 0.001). CONCLUSION: In this study, IPA was significantly more effective than P for N&V at the triage. Moreover, patients in the IPA group had less need for rescue treatment.

Disulfiram Ethanol Reaction with Alcohol-Based Hand Sanitizer: An Exploratory Study.

AIMS: We conducted a cross-sectional survey to estimate the prevalence and clinical manifestation of disulfiram ethanol reaction (DER) and isopropanol toxicity (IT) in patients with alcohol use disorders, on disulfiram. Alcohol-based hand rub contains either ethanol or isopropanol or both. COVID-19 pandemic has led to wide scale usage of sanitizers. Patients with alcohol use disorders, on disulfiram, might experience disulfiram ethanol like reactions with alcohol-based sanitizers. METHODS: We telephonically contacted 339 patients, prescribed disulfiram between January 2014 and March 2020. The assessment pertained to the last 3 months (i.e. third week of March to third week of June 2020). RESULT: The sample consisted of middle-aged men with a mean 16 years of alcohol dependence. Among the 82 (24%) patients adherent to disulfiram, 42 (12.3%) were using alcohol-based hand rubs. Out of these, a total of eight patients (19%; 95% CI 9-33) had features suggestive of DER; four of whom also had features indicative of IT. Five patients (62.5%) had mild and self-limiting symptoms. Severe systemic reactions were experienced by three (37.5%). Severe reactions were observed with exposure to sanitizers in greater amounts, on moist skin or through inhalation. CONCLUSION: Patients on disulfiram should be advised to use alternate methods of hand hygiene.

A Case Report of Isopropanol Ingestion During the SARS-CoV-2 Pandemic.

INTRODUCTION: Patients with substance use disorder may be particularly vulnerable to withdrawal-related complications during the SARS-CoV-2 (COVID-19) pandemic. Limited availability of alcohol and other substances coupled with decreased accessibility to substance use treatment poses a substantial risk to this population. Isopropanol, the active ingredient in rubbing alcohol, is widely available; thus, it may be used in times of scarcity. CASE REPORT: We present a case of intentional isopropanol ingestion used as an ethanol surrogate within the setting of the COVID-19 pandemic. CONCLUSIONS: Toxic alcohol ingestions are imperative considerations on the differential for the intoxicated patient particularly during resource-limited times.

Skin Preparation Techniques for Orthopedic Foot and Ankle Surgery: A Current Concepts Review.

Surgical site infection (SSI) following orthopedic foot and ankle surgery is associated with morbidity, mortality, and cost to the healthcare system. The local anatomy and physiology predispose patients undergoing procedures to elevated risk. In particular, sterilizing of the webspaces, nailfolds, and subungual areas presents challenges, and the preferred skin antisepsis technique for foot and ankle procedures has not yet been defined. Skin antiseptic solutions (SASs) consist of 3 main categories: alcohol, chlorhexidine, and iodine-based solutions. This review of the literature supports a combined chlorhexidine and alcohol preparation technique; however, there are a number of studies that suggest otherwise. In addition, there is variable evidence for the use of alternatives to the standard soft sponge application technique, including immersion, bristled brush, and cotton gauze application. These alternatives may have a particular advantage in the forefoot. Most studies to date use growth from skin swab cultures after skin preparation as the primary outcome. Higher-level studies with large subject populations and more meaningful clinical outcomes will be required to solidify guidelines for preoperative skin antisepsis prior to foot and ankle procedures.Level of Evidence: Level V, expert opinion.

Terra Firma-Forme Dermatosis: Rubbing with Alcohol Establishes the Diagnosis.

An 80-year-old man with a past medical history of basal cell carcinomas presented with an asymptomatic eruption on the chest during his biannual skin check for cancer. He had had no prior or current episodes of seborrheic dermatitis on the scalp, face, or chest. He showered and cleaned that area daily. Physical examination revealed multiple brown plaques on the upper central region of the chest (Figure 1A and B). A SMART (skin modified by alcohol rubbing test) evaluation was performed.1 A 70% isopropyl alcohol pad was used to firmly rub the area. The brown plaques and discoloration remained on the wipes (Figure 1C). The lesions on the chest completely cleared (Figure 1D).

Handrubbing with sprayed alcohol-based hand rub: an alternative method for effective hand hygiene.

BACKGROUND: Hand hygiene is crucial in infection prevention and control. It is unclear whether sprayed alcohol-based hand rub (ABHR) is non-inferior to the World Health Organization (WHO)-recommended method of handrubbing with poured ABHR. AIM: To test whether sprayed ABHR can be an alternative (non-inferior) method for effective hand hygiene with/without handrubbing. METHODS: A laboratory experiment was conducted with ABHR (isopropanol 60% v/v) according to European Norm 1500. Hand hygiene was performed by: (1) handrubbing with ABHR poured on to the palm of the hand; (2) handrubbing with sprayed ABHR; and (3) applying sprayed ABHR to hands without handrubbing. Hands were contaminated with Escherichia coli ATCC 10536, followed by hand hygiene and microbiological sampling. A generalized linear mixed model with a random intercept per subject was used to analyse the reduction in bacterial count following hand hygiene. FINDINGS: In total, 19 healthcare workers participated in the study. Handrubbing with sprayed ABHR was non-inferior [margin log10 0.6 colony-forming units (cfu)/mL] to the WHO-recommended method of handrubbing with poured ABHR; bacterial count reductions were log10 3.66 cfu/mL [95% confidence interval (CI) 1.68-5.64] and log10 3.46 cfu/mL (95% CI 1.27-5.65), respectively. Conversely, non-inferiority was not found for sprayed ABHR without handrubbing [bacterial count reduction log10 2.76 cfu/mL (95% CI 1.65-3.87)]. CONCLUSION: Handrubbing with sprayed ABHR was non-inferior to handrubbing with ABHR poured on to the palm of the hand to reduce bacterial counts on hands under experimental conditions. Handrubbing with sprayed ABHR may be an acceptable alternative hand hygiene method pending assessment in other settings and for other pathogens.

Carbon dioxide can eliminate operating room fires from alcohol-based surgical skin preps.

INTRODUCTION: Surgical fires are a rare event that still occur at a significant rate and can result in severe injury and death. Surgical fires are fueled by vapor from alcohol-based skin preparations in the presence of increased oxygen concentration and a spark from an energy device. Carbon dioxide (CO2) is used to extinguish electrical fires, and we sought to evaluate its effect on fire creation in the operating room. We hypothesize that CO2 delivered by the energy device will decrease the frequency of surgical fires fueled by alcohol-based skin preparations. METHODS: An ex vivo model with 15 × 15 cm section of clipped, porcine skin was used. A commercially available electrosurgical pencil with a smoke evacuation tip was connected to a laparoscopic CO2 insufflation system. The electrosurgical pencil was activated for 2 s at 30 watts coagulation mode immediately after application of alcohol-based surgical skin preparations: 70% isopropyl alcohol with 2% chlorhexidine gluconate (CHG-IPA) or 74% isopropyl alcohol with 0.7% iodine povacrylex (Iodine-IPA). CO2 was infused via the smoke evacuation pencil at flow rates from 0 to 8 L/min. The presence of a flame was determined visually and confirmed with a thermal camera (FLIR Systems, Boston, MA). RESULTS: Carbon dioxide eliminated fire formation at a flow rate of 1 L/min with CHG-IPA skin prep (0% vs. 60% with no CO2, p < 0.0001). Carbon dioxide reduced fire formation at 1 L/min (25% vs. 47% with no CO2, p = 0.1) with Iodine-IPA skin prep and fires were eliminated at 2 L/min of flow with Iodine-IPA skin prep (p < 0.0001). CONCLUSION: Carbon dioxide can eliminate surgical fires caused by energy devices in the presence of alcohol-based skin preps. Future studies should determine the optimal technique and flow rate of carbon dioxide in these settings.

Efficacy and safety of a novel antimicrobial preoperative skin preparation.

OBJECTIVE: Alternatives to skin preparation with conventional preoperative antiseptics are required because of adverse reactions and the potential emergence of resistance. Here, we present 2 phase 2 studies of ZuraGard (ZG), a novel formulation of isopropyl alcohol and functional excipients developed for preoperative skin antisepsis. METHODS: Microbial skin flora on abdominal and inguinal sites in healthy volunteers were quantitatively assessed following application of ZG versus a negative control (ZV) and a chlorhexidine/alcohol preparation, Chloraprep (CP). In trial 1, ZG administered for both recommended and abbreviated application times was compared with CP and ZV via bacterial reductions at 10 minutes, and 6 hours, 12 hours, and 24 hours following application. In trial 2, the 10-minute postapplication responder rates (RRs) for ZG, participants with abdominal ≥2 log10 per cm2, and inguinal ≥3 log10 per cm2 reductions in colony-forming units (CFU) were compared to RRs of participants treated with CP. RESULTS: In trial 1, ZG at the recommended application time reduced mean bacterial counts by ~3.18 log10 CFU/cm2 and ~2.98 log10 CFU/cm2 at abdominal and inguinal sites, respectively. Qualitatively similar reductions were observed for the abbreviated ZG application time and all CP applications. Application of ZV was ineffective. In trial 2, 10-minute RRs for ZG and CP exceeded 90% at abdominal sites. At inguinal sites, RRs were 83.3% for ZG and 86.7% for CP. No skin irritation or other adverse events were observed. CONCLUSIONS: ZG matched CP efficacy under these experimental conditions with immediate and persistent microbial reductions, including abbreviated application times. Further clinical studies of this novel preoperative antiseptic are merited.

Skin preparation for prevention of peripheral blood culture contamination in children.

BACKGROUND: In Japan, blood cultures for children are performed by pediatric residents, and povidone-iodine (PI) is the recommended solution for skin preparation. Given that PI needs to be applied for 1.5-2 min before venipuncture, skin preparation may be suboptimal if this is not followed. In this study, we investigated the blood culture contamination rate after skin preparation with only 70% isopropyl alcohol (IPA) or IPA plus PI. METHODS: We performed a retrospective study of patients aged ≤6 years who provided blood cultures in the emergency department or pediatric ward. Patients with indwelling central venous catheter were excluded. We evaluated the impact of changing the method of skin preparation, comparing the traditional method using IPA plus PI between 2008 and 2010 (IPA + PI group) with the simplified method using only IPA between 2015 and 2017 (IPA group). RESULTS: A total of 5,365 blood culture samples were eligible for this study. Of these, 171 (3.2%) had an organism identified in blood culture. Of the blood culture-positive samples, 68 (1.3%) were true positive and 103 (1.9%) were contaminated. Thirty-eight (1.6%) of 2,407 cultures in the IPA group were contaminated, whereas 65 (2.2%) of 2,958 cultures in the IPA + PI group were contaminated (OR, 0.72; 95%CI: 0.48-1.07; P = 0.1). Coagulase-negative Staphylococcus grew significantly less in the IPA group (1.7% vs 1.0%, P = 0.02). CONCLUSIONS: A single application of 70% IPA may be the optimal skin preparation method for obtaining peripheral blood cultures from children in Japan.

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.

Safety and efficacy of 2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: the ARCTIC randomised-controlled feasibility trial protocol.

INTRODUCTION: Catheter-related sepsis is one of the most dangerous complications of neonatal intensive care and is associated with significant morbidity and mortality. Use of catheter-care 'bundles' has reduced the incidence of catheter-related sepsis, although individual components have not been well studied. Better evidence is needed to guide selection of the most appropriate antiseptic solution for skin disinfection in preterm neonates. This study will inform the feasibility and design of the first randomised controlled trial to examine the safety and efficacy of alcohol-based versus aqueous-based chlorhexidine antiseptic formulations for skin disinfection prior to percutaneous central venous catheterisation in preterm neonates. The antiseptics to be compared are 2% chlorhexidine gluconate (CHG) aqueous and 2% CHG in 70% isopropyl alcohol. METHODS AND ANALYSIS: The Antiseptic Randomised Controlled Trial for Insertion of Catheters (ARCTIC) is a two-centre randomised-controlled feasibility trial. At least 100 preterm infants born at <34 weeks' gestation and due to undergo percutaneous insertion of a central venous catheter will be randomly allocated to receive prior skin disinfection with one of the two antiseptic solutions. Outcomes include: i) recruitment and retention rates; ii) completeness of data collection; iii) numbers of enrolled infants meeting case definitions for definite catheter-related sepsis, catheter-associated sepsis and catheter colonisation and iv) safety outcomes of skin morbidity scores recorded daily from catheter insertion until 48 hours post removal. The key feasibility metrics will be reported as proportions with 95% CIs. Estimated prevalence of catheter colonisation will allow calculation of sample size for the large-scale trial. The data will inform whether it will be feasible to progress to a large-scale trial. ETHICS AND DISSEMINATION: ARCTIC has been approved by the National Health Service Health Research Authority National Research Ethics Service Committee East of England (Cambridge South) (IRAS ID 163868), was adopted onto the National Institute of Health Research Clinical Research Network portfolio (CPMS ID 19899) and is registered with an International Standard Randomised Control Trials Number (ISRCTN: 82571474; Pre-results) and European Clinical Trials Database number 2015-000874-36. Dissemination plans include presentations at scientific conferences, scientific publications and sharing of the findings with parents via the support of Bliss baby charity. TRIAL REGISTRATION NUMBER: ISRCTN82571474; Pre-results.

Determination of ChloraPrep® drying time before neuraxial anesthesia in elective cesarean delivery. A prospective observational study.

BACKGROUND: ChloraPrep® is a skin antiseptic commonly used before neuraxial anesthesia. It is believed that skin must be allowed to dry to prevent nerve damage by seeding ChloraPrep® solution into the neuraxis. We aimed to determine ChloraPrep® drying time in pregnant women before initiation of neuraxial anesthesia. METHODS: In 18 parturients undergoing elective cesarean delivery the skin 'wetness' after standardized ChloraPrep® application was prospectively assessed by blotting the skin with tissue paper and observing for residual orange tint. The isopropyl alcohol drying time was indirectly assessed by measuring the alcohol vapor concentration above the skin with a volatile organic compound analyzer. The primary outcome was the time measured from the end of skin preparation until tissue paper was no longer stained with orange tint. The secondary outcome was the time measured from the end of skin preparation until an abrupt reduction of isopropyl alcohol vapor concentration indicating that no further significant evaporation of alcohol was occurring. RESULTS: The mean ChloraPrep® drying time assessed by blotting the skin with tissue paper was 123 s (SD 32 s, 95% CI 107 to 140 s, range 85-195 s). The estimated isopropyl alcohol drying time was 82 s (95% CI 77.4 to 86.3 s). CONCLUSION: Our results suggest that ChloraPrep® drying time may be longer than the current manufacturer-recommended guideline of three minutes. The amount of ChloraPrep® used, application methods, patient characteristics, and environmental factors could influence the drying time.