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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.
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Topical povidone iodine inhibits bacterial growth in the oral cavity of patients on mechanical ventilation: a randomized controlled study.
Tsuda, S, Soutome, S, Hayashida, S, Funahara, M, Yanamoto, S, Umeda, M
BMC oral health. 2020;(1):62
Abstract
BACKGROUND Topical 0.12% chlorhexidine has been used widely to prevent ventilator-associated pneumonia in patients undergoing mechanical ventilation. However, it is not approved for mucosal application in Japan. The aims of this study were to investigate if topical povidone iodine (i) inhibits bacterial growth and (ii) disrupts the balance of the oral microbiota. METHODS This randomized controlled clinical trial included 23 patients who underwent mechanical ventilation in the intensive care unit. The patients were divided randomly into two groups: the intervention group (n = 16) and the control group (n = 7). All patients received oral cleaning with 3% hydrogen peroxide, followed by irrigation with tap water. The patients in the intervention group received 10% povidone iodine applied topically to the oral cavity. The concentration of total bacteria in the oropharyngeal fluid were determined before, immediately after, 1 h, 2 h, and 3 h after oral care using the Rapid Oral Bacteria Quantification System, which is based on dielectrophoresis and impedance measurements. The number of streptococci, methicillin-resistant Staphylococcus aureus, Streptococcus pneumoniae, Pseudomonas aeruginosa, Porphyromonas gingivalis, and Candida albicans before, immediately after, 1 h, and 3 h after oral care were estimated based on real-time polymerase chain reaction data. RESULTS After irrigation of the oral cavity, the number of bacteria decreased, but increased again at 1 h after oral care in the control group; however, in the intervention group, the concentration of bacteria was significantly lower than that in the control group at 1 hour (p = 0.009), 2 h (p = 0.001), and 3 h (p = 0.001) after oral care. The growth of all bacterial species tested was inhibited in the intervention group at 3 h after oral care, suggesting that povidone iodine did not disturb the balance of the oral microbiota. CONCLUSIONS Topical application of povidone iodine after cleaning and irrigation of the oral cavity inhibited bacterial growth in the oropharyngeal fluid of patients on mechanical ventilation while not disrupting the balance of the oral microbiota. TRIAL REGISTRATION University Hospitals Medical Information Network Clinical Trials Registry (UMIN-CTR), UMIN000028307. Registered 1 September 2017.
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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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Abstract
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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Addressing the challenges in antisepsis: focus on povidone iodine.
Barreto, R, Barrois, B, Lambert, J, Malhotra-Kumar, S, Santos-Fernandes, V, Monstrey, S
International journal of antimicrobial agents. 2020;(3):106064
Abstract
OBJECTIVES Using antiseptics in wound care can promote healing by preventing and treating infection. However, using antiseptics can present many challenges, including issues with tolerability, inactivation by organic matter and the emergence of antimicrobial resistance/cross-resistance. This review discussed the key challenges in antisepsis, focusing on povidone-iodine (PVP-I) antiseptic. METHODS Literature searches were conducted in PubMed, in January 2019, with a filter for the previous 5 years. Searches were based on the antimicrobial efficacy, antiseptic resistance, wound healing properties, and skin tolerability for the commonly used antiseptics PVP-I, chlorhexidine gluconate (CHG), polyhexanide (PHMB), and octenidine (OCT). Additional papers were identified based on author expertise. RESULTS When compared with CHG, PHMB and OCT, PVP-I had a broader spectrum of antimicrobial activity against Gram-negative bacteria, actinobacteria, bacterial spores, fungi and viruses, and a similar and broad spectrum of activity against Gram-positive bacteria. PVP-I was also highly effective at eradicating bacterial biofilms, which is a vitally important consideration for wound care and infection control. Despite a long history of extensive use, no resistance or cross-resistance to PVP-I has been recorded, which is in contrast with other antiseptics. Despite previous misconceptions, it has been shown that PVP-I has low allergenic properties, low cytotoxicity and can promote wound healing through increased expression of transforming growth factor beta. CONCLUSION With increased understanding of the importance of tackling antimicrobial resistance and bacterial biofilms in acute and chronic wound care, alongside improved understanding of the challenges of antiseptic use, PVP-I remains a promising agent for the management of antisepsis.
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Safety alert for hospital environments and health professional: chlorhexidine is ineffective for coronavirus.
Assis, MS, Araújo, RAAM, Lopes, AMM
Revista da Associacao Medica Brasileira (1992). 2020;(Suppl 2):124-129
Abstract
An alarming fact was revealed by recent publications concerning disinfectants: chlorhexidine digluconate is ineffective for disinfecting surfaces contaminated by the new coronavirus. This is a finding that requires immediate disclosure since this substance is widely used for the disinfection of hands and forearms of surgeons and auxiliaries and in the antisepsis of patients in minimally invasive procedures commonly performed in hospital environments. The objective of this study is to compare the different disinfectants used for disinfection on several surfaces, in a review of worldwide works. Scientific studies were researched in the BVS (Virtual Health Library), PubMed, Medline, and ANVISA (National Health Surveillance Agency) databases. The following agents were studied: alcohol 62-71%, hydrogen peroxide 0.5%, sodium hypochlorite 0.1%, benzalkonium chloride 0.05-0.2%, povidone-iodine 10%, and chlorhexidine digluconate 0.02%, on metal, aluminum, wood, paper, glass, plastic, PVC, silicone, latex (gloves), disposable gowns, ceramic, and Teflon surfaces. Studies have shown that chlorhexidine digluconate is ineffective for inactivating some coronavirus subtypes, suggesting that it is also ineffective to the new coronavirus.
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Oxygen Embolism and Pneumocephalus After Hydrogen Peroxide Application During Minimally Invasive Transforaminal Lumbar Interbody Fusion Surgery: A Case Report and Literature Review.
Zou, P, Yang, JS, Wang, XF, Wei, JM, Guo, H, Zhang, B, Zhang, F, Chu, L, Hao, DJ, Zhao, YT
World neurosurgery. 2020;:201-204
Abstract
BACKGROUND Hydrogen peroxide (H2O2) solution is commonly used to irrigate wounds because of its hemostatic and antiseptic properties. Previous studies suggest that H2O2 can result in toxicity to keratinocytes and fibroblasts, but complications after H2O2 application, including oxygen embolism, which is one of the most severe, have rarely been reported. CASE DESCRIPTION A 40-year-old woman was diagnosed with L4-5 lumbar spinal stenosis and subsequently underwent minimally invasive transforaminal lumbar interbody fusion treatment at another hospital. Hypotension, hypoxia, and a decrease in end-tidal carbon dioxide pressure occurred immediately after H2O2 irrigation. After the operation, she was able to be extubated but remained comatose. Postoperative computed tomography scan revealed intracranial air trapping in the right frontal lobe and multiple cerebral infarction foci. CONCLUSIONS When using a knee-prone surgical position or in cases of dural laceration, the application of undiluted H2O2 solution should be avoided, especially in a surgical wound within a closed cavity. When hypotension, hypoxia, and a decrease in end-tidal carbon dioxide pressure occur immediately after H2O2 irrigation, oxygen embolism should be strongly suspected.
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Antibiotics versus topical antiseptics for chronic suppurative otitis media.
Head, K, Chong, LY, Bhutta, MF, Morris, PS, Vijayasekaran, S, Burton, MJ, Schilder, AG, Brennan-Jones, CG
The Cochrane database of systematic reviews. 2020;(1):CD013056
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BACKGROUND Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and infection of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss. Antibiotics and antiseptics kill or inhibit the micro-organisms that may be responsible for the infection. Antibiotics can be applied topically or administered systemically via the oral or injection route. Antiseptics are always directly applied to the ear (topically). OBJECTIVES To assess the effectiveness of antibiotics versus antiseptics for people with chronic suppurative otitis media (CSOM). SEARCH METHODS The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL; 2019, Issue 4, via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 1 April 2019. SELECTION CRITERIA We included randomised controlled trials (RCTs) with at least a one-week follow-up involving patients (adults and children) who had chronic ear discharge of unknown cause or CSOM, where ear discharge had continued for more than two weeks. The intervention was any single, or combination of, antibiotic agent, whether applied topically (without steroids) or systemically. The comparison was any single, or combination of, topical antiseptic agent, applied as ear drops, powders or irrigations, or as part of an aural toileting procedure. Two comparisons were topical antiseptics compared to: a) topical antibiotics or b) systemic antibiotics. Within each comparison we separated where both groups of patients had received topical antibiotic a) alone or with aural toilet and b) on top of background treatment (such as systemic antibiotics). DATA COLLECTION AND ANALYSIS We used the standard Cochrane methodological procedures. We used GRADE to assess the certainty of the evidence for each outcome. Our primary outcomes were: resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not), measured at between one week and up to two weeks, two weeks to up to four weeks, and after four weeks; health-related quality of life using a validated instrument; and ear pain (otalgia) or discomfort or local irritation. Secondary outcomes included hearing, serious complications and ototoxicity measured in several ways. MAIN RESULTS We identified seven studies (935 participants) across four comparisons with antibiotics compared against acetic acid, aluminium acetate, boric acid and povidone-iodine. None of the included studies reported the outcomes of quality of life or serious complications. A. Topical antiseptic (acetic acid) versus topical antibiotics (quinolones or aminoglycosides) It is very uncertain if there is a difference in resolution of ear discharge with acetic acid compared with aminoglycosides at one to two weeks (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.72 to 1.08; 1 study; 100 participants; very low-certainty evidence). No study reported results for ear discharge after four weeks. It was very uncertain if there was more ear pain, discomfort or local irritation with acetic acid or topical antibiotics due to the low numbers of participants reporting events (RR 0.16, 95% CI 0.02 to 1.34; 2 RCTs; 189 participants; very low-certainty evidence). No differences between groups were reported narratively for hearing (quinolones) or suspected ototoxicity (aminoglycosides) (very low-certainty evidence). B. Topical antiseptic (aluminium acetate) versus topical antibiotics No results for the one study comparing topical antibiotics with aluminium acetate could be used in the review. C. Topical antiseptic (boric acid) versus topical antibiotics (quinolones) One study reported more participants with resolution of ear discharge when using topical antibiotics (quinolones) compared with boric acid ear drops at between one to two weeks (risk ratio (RR) 1.56, 95% confidence interval (CI) 1.27 to 1.92; 1 study; 409 participants; moderate-certainty evidence). This means that one additional person will have resolution of ear discharge for every five people receiving topical antibiotics (compared with boric acid) at two weeks. No study reported results for ear discharge after four weeks. There was a bigger improvement in hearing in the topical antibiotic group compared to the topical antiseptic group (mean difference (MD) 2.79 decibels (dB), 95% CI 0.48 to 5.10; 1 study; 390 participants; low-certainty evidence) but this difference may not be clinically significant. There may be more ear pain, discomfort or irritation with boric acid compared with quinolones (RR 0.56, 95% CI 0.32 to 0.98; 2 studies; 510 participants; low-certainty evidence). Suspected ototoxicity was not reported. D. Topical antiseptic (povidone-iodine) versus topical antibiotics (quinolones) It is uncertain if there is a difference between quinolones and povidone-iodine with respect to resolution of ear discharge at one to two weeks (RR 1.02, 95% CI 0.82 to 1.26; 1 RCT, 39 participants; very low-certainty evidence). The study reported qualitatively that there were no differences between the groups for hearing and no patients developed ototoxic effects (very low-certainty evidence). No results for resolution of ear discharge beyond four weeks, or ear pain, discomfort or irritation, were reported. E. Topical antiseptic (acetic acid) + aural toileting versus topical + systemic antibiotics (quinolones) One study reported that participants receiving topical and oral antibiotics had less resolution of ear discharge compared with acetic acid ear drops and aural toileting (suction clearance every two days) at one month (RR 0.69, 95% CI 0.53 to 0.90; 100 participants). The study did not report results for resolution of ear discharge at between one to two weeks, ear pain, discomfort or irritation, hearing or suspected ototoxicity. AUTHORS' CONCLUSIONS Treatment of CSOM with topical antibiotics (quinolones) probably results in an increase in resolution of ear discharge compared with boric acid at up to two weeks. There was limited evidence for the efficacy of other topical antibiotics or topical antiseptics and so we are unable to draw conclusions. Adverse events were not well reported.
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Bacterial skin recolonization in the operating room: comparison between various antisepsis protocols.
Rouquette, L, Traore, O, Descamps, S, Boisgard, S, Villatte, G, Erivan, R
The Journal of hospital infection. 2020;(1):57-64
Abstract
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.
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Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol.
, , Slobogean, GP, Sprague, S, Wells, J, Bhandari, M, Rojas, A, Garibaldi, A, Wood, A, Howe, A, Harris, AD, et al
JAMA network open. 2020;(4):e202215
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IMPORTANCE The risk of developing a surgical site infection after extremity fracture repair is nearly 5 times greater than in most elective orthopedic surgical procedures. For all surgical procedures, it is standard practice to prepare the operative site with an antiseptic solution; however, there is limited evidence to guide the choice of solution used for orthopedic fracture repair. OBJECTIVE To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair. DESIGN, SETTING, AND PARTICIPANTS The PREP-IT (Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma) master protocol will be followed to conduct 2 multicenter pragmatic cluster randomized crossover trials, Aqueous-PREP (Pragmatic Randomized Trial Evaluating Pre-Operative Aqueous Antiseptic Skin Solution in Open Fractures) and PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities). The Aqueous-PREP trial will compare 4% aqueous chlorhexidine vs 10% povidone-iodine for patients with open extremity fractures. The PREPARE trial will compare 2% chlorhexidine in 70% isopropyl alcohol vs 0.7% iodine povacrylex in 74% isopropyl alcohol for patients with open extremity fractures and patients with closed lower extremity or pelvic fractures. Both trials will share key aspects of study design and trial infrastructure. The studies will follow a pragmatic cluster randomized crossover design with alternating treatment periods of approximately 2 months. The primary outcome will be surgical site infection and the secondary outcome will be unplanned fracture-related reoperations within 12 months. The Aqueous-PREP trial will enroll a minimum of 1540 patients with open extremity fractures from at least 12 hospitals; PREPARE will enroll a minimum of 1540 patients with open extremity fractures and 6280 patients with closed lower extremity and pelvic fractures from at least 18 hospitals. The primary analyses will adhere to the intention-to-treat principle and account for potential between-cluster and between-period variability. The patient-centered design, implementation, and dissemination of results are guided by a multidisciplinary team that includes 3 patients and other relevant stakeholders. DISCUSSION The PREP-IT master protocol increases efficiency through shared trial infrastructure and study design components. Because prophylactic skin antisepsis is used prior to all surgical procedures and the application, cost, and availability of all study solutions are similar, the results of the PREP-IT trials are poised to inform clinical guidelines and bring about an immediate change in clinical practice. TRIAL REGISTRATION ClinicalTrials.gov Identifiers: NCT03385304 and NCT03523962.
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Preoperative skin antisepsis using chlorhexidine may reduce surgical wound infections in lower limb trauma surgery when compared to povidone-iodine - a prospective randomized trial.
Ritter, B, Herlyn, PKE, Mittlmeier, T, Herlyn, A
American journal of infection control. 2020;(2):167-172
Abstract
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.