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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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The effect of tooth brushing, irrigation, and topical tetracycline administration on the reduction of oral bacteria in mechanically ventilated patients: a preliminary study.
Hayashida, S, Funahara, M, Sekino, M, Yamaguchi, N, Kosai, K, Yanamoto, S, Yanagihara, K, Umeda, M
BMC oral health. 2016;(1):67
Abstract
BACKGROUND One of the main causes of ventilator-associated pneumonia (VAP) is thought to be aspiration of oropharyngeal fluid containing pathogenic microorganisms. The aim of this study was to examine the effects of various oral care methods on the reduction of oral bacteria during intubation. METHODS First, the effect of mechanical oral cleaning was investigated. The bacterial count on the tongue and in the oropharyngeal fluid was measured after tooth brushing, irrigation, and three hours after irrigation in mechanically ventilated patients at the intensive care unit (ICU). Next, the efficacy of topical administration of tetracycline and povidone iodine on the inhibition of bacterial growth on the tongue and in the oropharyngeal fluid was examined in oral cancer patients during neck dissection. RESULTS The number of bacteria in the oropharyngeal fluid was approximately 10(5)-10(6) cfu/mL before surgery, but increased to 10(8) cfu/mL after intubation. Oral care with tooth brushing and mucosal cleaning did not reduce oral bacteria, while irrigation of the oral cavity and oropharynx significantly decreased it to a level of 10(5) cfu/mL (p < 0.001). However, oral bacteria increased again to almost 10(8) cfu/mL within three hours of irrigation. Oral bacteria did not decrease by topical povidone iodine application. In contrast, 30 min after topical administration of tetracycline, the number of oral bacteria decreased to 10(5) cfu/mL, and remained under 10(6) cfu/mL throughout the entire experimental period of 150 min. CONCLUSIONS While the present studies are only preliminary, these results indicate that irrigation of the oral cavity and oropharynx followed by topical antibiotic administration may reduce oral bacteria in mechanically ventilated patients. TRIAL REGISTRATION UMIN000018318 , 1 August 2015.
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A prospective, non comparative, multicenter study to investigate the effect of cadexomer iodine on bioburden load and other wound characteristics in diabetic foot ulcers.
Schwartz, JA, Lantis, JC, Gendics, C, Fuller, AM, Payne, W, Ochs, D
International wound journal. 2013;(2):193-9
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Abstract
Few studies regarding wound treatment with topical antimicrobials evaluate change in the bacterial bioburden of the wound with treatment. This study sought out to determine the in vivo effect of cadexomer iodine antibacterial dressing on diabetic foot ulcers (DFUs) that were infected or achieved a critical level of colonisation, looking specifically at wound progression in relation to bioburden. Fifteen patients corresponding to 16 total DFUs met criteria of displaying clinical signs of infection or critical colonisation and were suitable for a topical antibacterial dressing. They underwent weekly treatment for 6 weeks. Cultures were taken at week 0, 3 and 6 as appropriate. At week 6 median log10 bacterial count reduction of 1.0 was observed from baseline (p = 0·025). At week 3- a median log10 bacterial count reduction of 0.3 was observed from baseline (p = 0·049). Over the study period there was a 53.6% median reduction of the wound surface area. There were no patients that completely healed their ulcer over the 6 week study period. There was a statistically significant median reduction in the bacterial load over the 6 week period (p = 0·025) as well as 3 weeks (p = 0·049). This was accompanied by a median reduction of 53.6% in ulcer surface area and 50% in ulcer depth from baseline to final.
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Innovative antimicrobial coating of titanium implants with iodine.
Tsuchiya, H, Shirai, T, Nishida, H, Murakami, H, Kabata, T, Yamamoto, N, Watanabe, K, Nakase, J
Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association. 2012;(5):595-604
Abstract
BACKGROUND Postoperative infection associated with implants remains a serious complication in orthopedic surgery. Several biomaterial surface treatments have been proposed as a means of reducing the incidence of implant-associated infections. In this study, a clinical trial was performed using an iodine-supported titanium that suppresses the microbial activities. METHODS A total of 222 patients with postoperative infection or compromised status were treated using iodine-supported titanium implants. The mean age of the patients was 49.4 years (range 5-85 years). One hundred twenty-seven patients were male and 95 were female. In 158 patients, iodine-supported implants were used to prevent infection, such as compromised hosts and conditions, and in 64 patients to treat active infection. White blood cell (WBCs) and C-reactive protein (CRP) levels were measured pre- and postoperatively in all patients. To confirm whether iodine from the implant affected physiological functions, thyroid hormone levels in the blood were examined. Both examinations were conducted sequentially for a year. Radiological evaluations were performed regularly after the operation. The chronological changes of the iodine amount were evaluated using half pins removed after completion of external fixation. RESULTS The mean follow-up period was 18.4 months (range 3-44 months). Acute infection developed in three tumor cases among the 158 patients on preventive therapy. All three recovered without removal of the implants. Infection was cured in all 64 patients with infection. Median WBC levels were in the normal range, and median CRP levels returned to <0.5 within 4 weeks after surgery. Abnormalities of thyroid gland function were not detected. None of the patients experienced loosening of the implants. There were two patients with mechanical implant failure, which was treated by re-implantation. Excellent bone ingrowth and ongrowth were found around all hip and tumor prostheses. One year later, the amount of iodine on external fixation pins remained about 20-30%. CONCLUSIONS Iodine-supported titanium implants can be very effective for preventing and treating infections after orthopedic surgery. Cytotoxicity and adverse effects were not detected.
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Fluoroscopy guided instillation therapy in chyluria using combination of povidone iodine with contrast agent. Is a single instillation sufficient?
Sharma, G, Chitale, V, Karva, R, Sharma, A, Durug, AB
International braz j urol : official journal of the Brazilian Society of Urology. 2008;(3):270-5; discussion 275-6
Abstract
PURPOSE To evaluate the safety and efficacy of a single instillation in a combination of povidone iodine with contrast agent under fluoroscopy guidance for the treatment of chyluria. MATERIALS AND METHODS From December 1999 to July 2006 a total of 40 patients with chyluria were treated by renal pelvic instillation therapy (RPIS). The sclerosing solution was prepared using povidone iodine with contrast agent diluted with sterile water in a ratio of 1:1:3. It was instilled on the side having chylous efflux using a bulb tip ureteric catheter. Unilateral instillation was done in 26 cases, 10 on the right side and 16 on left. Fourteen patients had bilateral chylous efflux and RPIS was performed on both sides in the same session. Fluoroscopy was used to evaluate the complete filling of the pelvic calyceal system. The sclerosing solution was kept in the system for 5 minutes and the ureteric catheter was then withdrawn. RESULTS Immediate clearance was observed in 39 patients. Recurrence occurred in five patients. They were treated again using the same procedure with satisfactory results. The longest follow-up was five years and the shortest five months. CONCLUSION RPIS of chyluria using a single instillation a combination of povidone iodine with contrast agent is safe and effective. Use of fluoroscopy helps to determine the exact amount of sclerosing solution required to completely fill the system and therefore overfilling is avoided. Moreover, the complications, which arise due to pyelointerstitial backflow, are prevented.
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A unique water optional health care personnel handwash provides antimicrobial persistence and residual effects while decreasing the need for additional products.
Seal, LA, Rizer, RL, Maas-Irslinger, R
American journal of infection control. 2005;(4):207-16
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Abstract
BACKGROUND The Centers for Disease Control and Prevention (CDC) has published guidelines for hand hygiene practices, recommending a handwash regimen that alternates between waterless alcohol products and antimicrobial or nonantimicrobial soap and water. The advent of an alcohol-based product that can be used with or without water (ie, water optional) to decontaminate the hands while providing immediacy of kill and antimicrobial persistence could reduce the confusion associated with handwash guidelines. Such a product has been developed, is alcohol-based (61%), and zinc pyrithione (ZPT) preserved (61% alcohol-ZPT) and has proven to be fully compliant with the Food and Drug Administration (FDA) and CDC guidelines. METHODS FDA-required testing of the 61% alcohol-ZPT product for the health care personnel handwash indication was performed as outlined in the Tentative Final Monograph (TFM) for Health-Care Antiseptic Drug Products, employing waterless and water-aided product applications. It was next assessed for antimicrobial persistence and residual effects by comparing it, in separate waterless and water-aided applications, with commonly available handwashes containing various antimicrobials in a 5-day study employing 49 subjects, in which samples were collected immediately and at 4 hours and 8 hours postapplication. The skin conditioning properties of this formulation were investigated via appropriate methods. RESULTS The 61% alcohol-ZPT product easily produced >3.0 log 10 reduction in the indicator strain ( Serratia marcescens ) following the first wash, exceeding the 2.0 log 10 FDA requirement. This level of performance was maintained through the tenth wash, surpassing the 3.0 log 10 FDA requirement for the handwash indication. For the assessment of persistence and residual effect in the waterless mode, the water-optional, 61% alcohol-ZPT product consistently produced log 10 reductions of nearly 3.5 or greater at every point over the entire study period. In the water-aided configuration, similar results were obtained as log 10 reductions of 2.5 were observed. The formulation is nonirritating, actually contributing to hand skin condition. CONCLUSIONS The 61% alcohol-ZPT product exceeds all FDA criteria for the health care personnel handwash indication and is a significant advancement in the concept of skin antisepsis. It represents a single product suitable for use in all hand hygiene settings, demonstrating improved antimicrobial persistence and residual effects. The 61% alcohol-ZPT formulation contributes positively to overall hand conditioning, and a previously reported study has documented it to be virucidal for several DNA and RNA viruses.
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Evaluation of effectiveness of 10% polyvinylpyrrolidone-iodine solution against infections in wire and pin holes for Ilizarov external fixators.
Camilo, AM, Bongiovanni, JC
Sao Paulo medical journal = Revista paulista de medicina. 2005;(2):58-61
Abstract
CONTEXT AND OBJECTIVE Superficial infection at wire and pin insertions in the skin is a frequent disorder among patients utilizing the Ilizarov method. The objective of this study was to evaluate the effectiveness of daily topical application of 10% polyvinylpyrrolidone-iodine solution against infections of the holes for Kirschner wires and Schanz pins among patients using Ilizarov external fixators, in comparison with cleaning these holes only with 0.9% sterile physiological saline solution. DESIGN AND SETTING Controlled randomized clinical trial, in the Orthopedics and Traumatology Outpatient Clinic, Hospital São Paulo, and Orthopedics and Traumatology Center of Jundiaí. METHODS 30 patients were treated using the Ilizarov technique: 15 were instructed to apply 0.9% physiological saline dressing on the wire and pin insertions and 15 to apply 0.9% physiological saline plus 10% polyvinylpyrrolidone-iodine. Patients were evaluated at outpatient return visits for identification of signs and symptoms of superficial infection at wire and pin insertion sites. Samples were collected from cases of purulent exudate secretion, for culturing and clinical tests. RESULTS The chi-squared and Fischer exact tests were applied, but no statistically significant association between the intervention of topical polyvinylpyrrolidone-iodine solution and the prevention of infections at wire and pin insertions could be found. CONCLUSIONS Topical 10% polyvinylpyrrolidone-iodine solution applied daily to Kirschner wire and Schanz pin insertions did not reduce the incidence of superficial infection at these holes, in comparison with mechanical removal of dirt using 0.9% physiological saline solution.
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[Effect of mouthwashing with tea tree oil on plaque and inflammation].
Saxer, UP, Stäuble, A, Szabo, SH, Menghini, G
Schweizer Monatsschrift fur Zahnmedizin = Revue mensuelle suisse d'odonto-stomatologie = Rivista mensile svizzera di odontologia e stomatologia. 2003;(9):985-96
Abstract
The tea tree oil (melaleuca alternifolia) has antiseptic, fungicide and bactericide effects. The efficiency against oral bacteria was also evident. Xylitol is known for counterattacking the cariogenic effect caused by the streptococcus mutans. Less plaque was developed during the time of the study.