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Efficacy of commercial mouth-rinses on SARS-CoV-2 viral load in saliva: randomized control trial in Singapore.
Seneviratne, CJ, Balan, P, Ko, KKK, Udawatte, NS, Lai, D, Ng, DHL, Venkatachalam, I, Lim, KS, Ling, ML, Oon, L, et al
Infection. 2021;(2):305-311
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PURPOSE One of the key approaches to minimize the risk of COVID-19 transmission would be to reduce the titres of SARS-CoV-2 in the saliva of infected COVID-19 patients. This is particularly important in high-risk procedures like dental treatment. The present randomized control trial evaluated the efficacy of three commercial mouth-rinse viz. povidone-iodine (PI), chlorhexidine gluconate (CHX) and cetylpyridinium chloride (CPC), in reducing the salivary SARS-CoV-2 viral load in COVID-19 patients compared with water. METHODS A total of 36 SARS-CoV-2-positive patients were recruited, of which 16 patients were randomly assigned to four groups-PI group (n = 4), CHX group (n = 6), CPC group (n = 4) and water as control group (n = 2). Saliva samples were collected from all patients at baseline and at 5 min, 3 h and 6 h post-application of mouth-rinses/water. The samples were subjected to SARS-CoV-2 RT-PCR analysis. RESULTS Comparison of salivary Ct values of patients within each group of PI, CHX, CPC and water at 5 min, 3 h and 6 h time points did not show any significant differences. However, when the Ct value fold change of each of the mouth-rinse group patients were compared with the fold change of water group patients at the respective time points, a significant increase was observed in the CPC group patients at 5 min and 6 h and in the PI group patients at 6 h. CONCLUSION The effect of decreasing salivary load with CPC and PI mouth-rinsing was observed to be sustained at 6 h time point. Within the limitation of the current study, as number of the samples analyzed, the use of CPC and PI formulated that commercial mouth-rinses may be useful as a pre-procedural rinse to help reduce the transmission of COVID-19. ISRCTN (ISRCTN95933274), 09/09/20, retrospectively registered.
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Oral antiseptics against coronavirus: in-vitro and clinical evidence.
Mateos-Moreno, MV, Mira, A, Ausina-Márquez, V, Ferrer, MD
The Journal of hospital infection. 2021;:30-43
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Angiotensin converting enzyme 2 (ACE2) is the cellular receptor for SARS-CoV-2, so ACE2-expressing cells can act as target cells and are susceptible to infection. ACE2 receptors are highly expressed in the oral cavity, so this may be a potential high-risk route for SARS-CoV-2 infection. Furthermore, the virus can be detected in saliva, even before COVID-19 symptoms appear, with the consequent high risk of virus transmission in asymptomatic/presymptomatic patients. Reducing oral viral load could lead to a lower risk of transmission via salivary droplets or aerosols and therefore contribute to the control of the pandemic. Our aim was to evaluate the available evidence testing the in-vitro and in-vivo effects of oral antiseptics to inactivate or eradicate coronaviruses. The criteria used were those described in the PRISMA declaration for performing systematic reviews. An electronic search was conducted in Medline (via PubMed) and in Web of Sciences, using the MeSH terms: 'mouthwash' OR 'oral rinse' OR 'mouth rinse' OR 'povidone iodine' OR 'hydrogen peroxide' OR 'cetylpyridinium chloride' AND 'COVID-19' OR 'SARS-CoV-2' OR 'coronavirus' OR 'SARS' OR 'MERS'. The initial search strategy identified 619 articles on two electronic databases. Seventeen articles were included assessing the virucidal efficacy of oral antiseptics against coronaviruses. In conclusion, there is sufficient in-vitro evidence to support the use of antiseptics to potentially reduce the viral load of SARS-CoV-2 and other coronaviruses. However, in-vivo evidence for most oral antiseptics is limited. Randomized clinical trials with a control group are needed to demonstrate its clinical efficacy.
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The effect of vaginal disinfection on reducing post-caesarean endometritis: A prospective, randomised controlled trial.
Bağlı, İ, Ege, S, Bademkıran, H, Obut, M, Kahveci, B, Turan, G, Kahramanoğlu, Ö
Journal of gynecology obstetrics and human reproduction. 2021;(3):101981
Abstract
PURPOSE We aimed to evaluate the efficacy of vaginal disinfection using 10 % povidone-iodine on rates of endometritis from post-caesarean infectious diseases before elective caesarean section (CS). METHODS A total of 270 pregnant women who chose to undergo elective CS were recruited for this prospective randomised controlled study. The experimental group comprised 130 patients who had preoperatively undergone vaginal disinfection with 10 % povidone-iodine for 30 s. The control group consisted of 140 patients who had not undergone any vaginal implication before CS. The primary outcome measure was the rate of postpartum endometritis for each group. Intraoperatively, all patients who had closed uterine cervical canals underwent a digital opening of the internal and external cervical canal to equalise the groups. All of the participants were checked for endometritis one week after CS at the hospital. Additionally, for the week before and after surgery, C-reactive protein (CRP) and white blood cell (WBC) values were assessed for both groups. Ethics committee approval number: 339. Statistical analysis was performed using R version 3.5.1 (R statistical Software, Institute for Statistics and Mathematics, Vienna, Austria). RESULTS The groups were balanced in terms of the patients' demographic characteristics. There were no significant differences between the two groups according to endometritis rates: 4.6 % in the study group versus 6.4 % in the control group (p > 0.05). The CRP and WBC values before CS were similar in both groups. In the study group, the CRPand WBC values after CS were lower, whereas they were higher in the control group after CS; these differences were significant (p = 0.01 for CRP and p = 0.001 for WBC). CONCLUSION Vaginal disinfection with povidone-iodine solution 10 % before elective CS does not significantly reduce post-caesarean endometritis rates; however, it does significantly reduce inflammatory markers such as CRP and WBC.
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Tolerability and usability of 0.5% PVP-I gargles and nasal drops in 6692 patients: Observational study.
Khan, MM, Parab, SR
American journal of otolaryngology. 2021;(2):102880
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OBJECTIVES STUDY DESIGN Observational study. SETTING Secondary care ENT Centre. METHODS All patients attending the hospital for office ENT consultations from 15th April 2020 to 15th September 2020 were included in the study. A total of 6692 office patients were evaluated for feasibility, usability and tolerability of the 0.5% PVP-I gargles and nasal drops. RESULTS Overall practicability of using 0.5% PVP-I gargles and nasal drops at office level was assessed in terms of feasibility and usability. Feasibility and usability was considered in terms of the ease of the dispensing method of the 0.5% PVP-I gargles and nasal drops by the health care workers to the patients prior to ENT examination. Tolerance was assessed in terms of altered taste, staining of teeth or nasal skin or irritation in the nose. None reported any serious reactions or adverse effects following use of 0.5% PVP-I. CONCLUSION The study reports the successful feasibility and usability of 0.5% PVP-I gargles and nasal drops and bears the potential to provide benefits in preventing transmission from the patients to the health care workers and vice versa. LEVEL OF EVIDENCE 4.
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Virucidal effect of povidone iodine on COVID-19 in the nasopharynx: A structured summary of a study protocol for an open-label randomized clinical trial.
Hasan, MJ, Rumi, SKNF, Banu, SS, Uddin, AKMN, Islam, MS, Arefin, MK
Trials. 2021;(1):2
Abstract
OBJECTIVE General: To assess the virucidal efficacy of povidone iodine (PVP-I) on COVID-19 virus located in the nasopharynx Specific: i. To evaluate the efficacy of povidone iodine (PVP-I) to removeCOVID-19 virus located in the nasopharynx ii. To assess the adverse events of PVP-I TRIAL DESIGN This is a single-center, open-label randomized clinical trial with a 7-arm parallel-group design. PARTICIPANTS The study will be conducted at Dhaka Medical College Hospital, Dhaka, Bangladesh. INCLUSION CRITERIA All RT-PCR-confirmed COVID-19 cases aged between 15-90 years with symptoms for the past 4 days will be screened. Those who give informed consent, are willing to participate, and accept being randomized to any assigned group will also be considered for final inclusion. EXCLUSION CRITERIA Patients with known sensitivity to PVP-I aqueous antiseptic solution or any of its listed excipients or previously diagnosed thyroid disease or who had a history of chronic renal failure: stage ≥3 by estimated glomerular filtration rate (eGFR) Modification of Diet in Renal Disease (MDRD) or had acute renal failure (KDIGO ≥stage 2: creatinine ≥2 times from the baseline) or patients who required invasive or noninvasive ventilation or planned within the next 6 hours were considered for exclusion. Moreover, lactating or pregnant women will also be restricted to include here. INTERVENTION AND COMPARATOR This RCT consist of seven arms: Arm-1 (intervention group): will receive povidone iodine (PVP-I) nasal irrigation (NI) at a concentration of 0.4% Arm-2 (intervention group): will receive PVP-I nasal irrigation at a concentration of 0.5% Arm-3 (intervention group): will receive PVP-I nasal irrigation at a concentration of 0.6%. Arm-4 (intervention group): will receive PVP-I nasal spray (NS) at a concentration of 0.5%. Arm-5 (intervention group): will receive PVP-I nasal spray at a concentration of 0.6%. Arm-6 (placebo comparator group): will receive distilled water through NI Arm-7 (Placebo comparator group): will receive distilled water through NS The intervention arms will be compared to the placebo comparator arms. Other supportive and routine care will be the same in both groups. MAIN OUTCOMES The primary outcome is the proportion of cases that remain COVID-19 positive following the intervention. It will be assessed from 1 minutes to 15 minutes after the intervention. Any occurrence of adverse effects following the intervention will be documented as a secondary outcome. RANDOMIZATION The assignment to the study (intervention) or control (comparator) group will be allocated in equal numbers through randomization using random number generation in Microsoft Excel by a statistician who is not involved in the trial. The allocation scheme will be made by an independent statistician using a sealed envelope. The participants will be allocated immediately after the eligibility assessment and consenting procedures. BLINDING (MASKING): This is an open-label clinical trial, and no blinding or masking will be performed. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): A total of 189 confirmed cases of COVID-19 will be randomized into seven groups. In each arm, a total of 27 participants will be recruited. TRIAL STATUS The current trial protocol is Version 1.5 from September 10, 2020. Recruitment began September 30, 2020 and is anticipated to be completed, including data analysis by February 28, 2021. TRIAL REGISTRATION The trial protocol has been registered in the ClinicalTrials.gov on September 16, 2020. NCT Identifier number: NCT04549376 . FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.
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Comparison of the antimicrobial efficacy of povidone-iodine-alcohol versus chlorhexidine-alcohol for surgical skin preparation on the aerobic and anaerobic skin flora of the shoulder region.
Dörfel, D, Maiwald, M, Daeschlein, G, Müller, G, Hudek, R, Assadian, O, Kampf, G, Kohlmann, T, Harnoss, JC, Kramer, A
Antimicrobial resistance and infection control. 2021;(1):17
Abstract
BACKGROUND Cutibacterium acnes is part of the anaerobic skin microbiome and resides in deeper skin layers. The organism is an agent of surgical site infections (SSI) in shoulder surgery. We hypothesized that prolonged skin preparation with an agent that penetrates deeply into the skin would be beneficial. Thus, we compared two classes of antiseptics, each combined with alcohol, each applied with two different contact times. METHODS Using a cross-over arrangement, shoulders of 16 healthy volunteers were treated for 2.5 min (standard) or 30 min (prolonged) with alcohol-based chlorhexidine (CHG-ALC) or alcohol-based povidone-iodine (PVP-I-ALC). Skin sites were sampled before, immediately after, and 3 h after treatment, using a standardized cup-scrub technique. RESULTS Aerobic skin flora was reduced more effectively by PVP-I-ALC than by CHG-ALC after 2.5 min application and immediate sampling (reduction factor [RF] 2.55 ± 0.75 vs. 1.94 ± 0.91, p = 0.04), but not after prolonged contact times and 3-h sampling. Coagulase-negative staphylococci were completely eliminated after PVP-I-ALC application, but still recovered from 4 of 32 samples after CHG-ALC application. Anaerobic flora was reduced more effectively by PVP-I-ALC than CHG-ALC after standard (RF 3.96 ± 1.46 vs. 1.74 ± 1.24, p < 0.01) and prolonged (RF 3.14 ± 1.20 vs. 1.38 ± 1.16, p < 0.01) contact times and immediate sampling, but not after 3-h sampling. No adverse events were reported. CONCLUSIONS PVP-I-ALC showed marginal benefits concerning the aerobic flora, but more substantial benefits over CHG-ALC concerning the anaerobic flora of the shoulder. Standard and prolonged contact times showed superiority for PVP-I-ALC for anaerobic flora at all immediate sampling points, but missed significance at 3-h sampling. The results underscore the need for protection against C. acnes and coagulase-negative staphylococci in orthopaedic surgery. The clinical relevance of these findings, however, should be studied with SSI as an endpoint.
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Ingestion of food grade hydrogen peroxide with resultant gastrointestinal and neurologic symptoms treated with hyperbaric oxygen therapy: case report and review with emphasis on the therapeutic value of HBO2 in vascular gas embolism.
Pak, S, Valencia, D, Lee, C, Lach, J, Ortiz, G
Undersea & hyperbaric medicine : journal of the Undersea and Hyperbaric Medical Society, Inc. 2021;(2):177-186
Abstract
A 52-year-old male accidentally ingested approximately 100 mL of 35% hydrogen peroxide (H2O2), resulting in the sudden onset of gastrointestinal and neurologic symptoms. Non-contrast abdominal CT revealed extensive portal venous gas and gastric pneumatosis. The patient was treated with hyperbaric oxygen therapy which resulted in complete resolution of symptoms. The case highlights the therapeutic value of hyperbaric oxygen therapy in the treatment of vascular gas embolism and mitigation of concentrated H2O2 ingestion toxicity.
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Chlorhexidine plus alcohol versus povidone iodine plus alcohol, combined or not with innovative devices, for prevention of short-term peripheral venous catheter infection and failure (CLEAN 3 study): an investigator-initiated, open-label, single centre, randomised-controlled, two-by-two factorial trial.
Guenezan, J, Marjanovic, N, Drugeon, B, Neill, RO, Liuu, E, Roblot, F, Palazzo, P, Bironneau, V, Prevost, F, Paul, J, et al
The Lancet. Infectious diseases. 2021;(7):1038-1048
Abstract
BACKGROUND Two billion peripheral venous catheters are sold globally each year, but the optimal skin disinfection and types of devices are not well established. We aimed to show the superiority of disinfection with 2% chlorhexidine plus alcohol over 5% povidone iodine plus alcohol in preventing infectious complications, and of closed integrated catheters, positive displacement needleless-connectors, disinfecting caps, and single-use prefilled flush syringes used in combination (innovation group) over open catheters and three-way stopcocks for treatment administration (standard group) in preventing catheter failure. METHODS We did an open-label, randomised-controlled trial with a two-by-two factorial design, for which we enrolled adults (age ≥18 years) visiting the emergency department at the Poitiers University Hospital, France, and requiring one peripheral venous catheter before admission to the medical wards. Before catheter insertion, patients were randomly assigned (1:1:1:1) using a secure web-based random-number generator to one of four treatment groups based on skin preparation and type of devices (innovative devices or standard devices; 2% chlorhexidine plus alcohol or 5% povidone iodine plus alcohol). Primary outcomes were the incidence of infectious complications (local infection, catheter colonisation, or bloodstream infections) and time between catheter insertion and catheter failure (occlusion, dislodgment, infiltration, phlebitis, or infection). This study is registered with ClinicalTrials.gov, NCT03757143. FINDINGS 1000 patients were recruited between Jan 7, and Sept 6, 2019, of whom 500 were assigned to the chlorhexidine plus alcohol group and 500 to the povidone iodine plus alcohol group (250 with innovative solutions and 250 with standard devices in each antiseptic group). No significant interaction was found between the two study interventions. Local infections occurred less frequently with chlorhexidine plus alcohol than with povidone iodine plus alcohol (0 [0%] of 496 patients vs six [1%] of 493 patients) and the same was observed for catheter colonisation (4/431 [1%] vs 70/415 [17%] catheters among the catheters cultured; adjusted subdistribution hazard ratio 0·08 [95% CI 0·02-0·18]). Median time between catheter insertion and catheter failure was longer in the innovation group compared with the standard group (50·4 [IQR 29·6-69·4] h vs 30·0 [16·6-52·6] h; p=0·0017). Minor skin reactions occurred in nine (2%) patients in the chlorhexidine plus alcohol group and seven (1%) patients in the povidone iodine plus alcohol group. INTERPRETATION For skin antisepsis, chlorhexidine plus alcohol provides greater protection of peripheral venous catheter-related infectious complications than does povidone iodine plus alcohol. Use of innovative devices extends the catheter complication-free dwell time. FUNDING Becton Dickinson.
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Considerations for povidone-iodine antisepsis in pediatric nasal and pharyngeal surgery during the COVID-19 pandemic.
Chorney, SR, Rizzi, MD, Dedhia, K
American journal of otolaryngology. 2020;(6):102737
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PURPOSE Surgeons resuming elective procedures during the COVID-19 pandemic should consider strategies to mitigate risk of exposure. For otolaryngologists performing surgery on children, unique vulnerability to SARS-CoV-2 results from a regular interface with the upper respiratory tract mucosa. A growing interest in perioperative application of povidone‑iodine (PVP-I) to the nasopharynx and oropharynx has emerged. The purpose of this review is to provide an evidence-based assessment of PVP-I in pediatric oral, nasal and pharyngeal surgery. METHODS A contemporary literature review with algorithmic approach to the potential use of PVP-I in pediatric mucosal surgery. RESULTS Several formulations of PVP-I have shown rapid in vitro virucidal activity against SARS-CoV-2. Antisepsis using 1.0% PVP-I mouthwash and 0.45% PVP-I throat spray can occur after 30 seconds of contact time. To date, in vivo effectiveness of PVP-I against SARS-CoV-2 has yet to be established and possible risks of its direct use on upper aerodigestive mucosa of children must be weighed. CONCLUSION Further research is required prior to strongly recommending PVP-I use in preparation for nasal, oral or pharyngeal surgery in children.
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A Prospective, Randomized Trial of Povidone-Iodine 0.6% and Dexamethasone 0.1% Ophthalmic Suspension for Acute Bacterial Conjunctivitis.
Ta, CN, Raizman, MB, Gross, RD, Joshi, S, Mallick, S, Wang, Y, Segal, B
American journal of ophthalmology. 2020;:56-65
Abstract
PURPOSE To evaluate the efficacy and safety of a topical ophthalmic suspension combination of povidone-iodine 0.6% (PVP-I) and dexamethasone 0.1% (DEX) for infectious and inflammatory components of bacterial conjunctivitis. DESIGN Randomized, double-masked, multicenter, phase 3 clinical trial. METHODS Subjects of all ages (those <3 months had to be full-term) with a diagnosis of bacterial conjunctivitis were randomized 3:1:3 to either PVP-I/DEX, PVP-I alone, or placebo. The primary endpoint was clinical resolution in the study eye, and the key secondary efficacy endpoint was bacterial eradication, both at the day 5 visit. Adverse events (AEs) were documented at all visits. RESULTS Overall, 753 subjects were randomized (intent-to-treat [ITT] population; PVP-I/DEX [n = 324]; PVP-I [n = 108]; placebo [n = 321]); mean and standard deviation (SD) age was 44.3 (22.9) years, and most were female (61.2%) and white (78.1%). In all treatment groups, mean treatment compliance was >98%. The modified ITT population for the efficacy analysis comprised 526 subjects. In the study eye at the day 5 visit, clinical resolution was achieved by 50.5% (111/220) subjects in the PVP-I/DEX group vs 42.8% (95/222) in the placebo group (P = .127), and bacterial eradication was achieved by 43.3% (94/217) and 46.8% (102/218), respectively (P = .500). Treatment-emergent AEs were experienced by 32.8% (106/323), 39.8% (43/108), and 19.0% (61/321) of subjects in the safety population treated with PVP-I/DEX, PVP-I, and placebo, respectively (most mild in severity). CONCLUSION In this study, PVP-I/DEX did not demonstrate additional benefit in clinical efficacy compared with placebo in subjects with bacterial conjunctivitis.