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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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Antimicrobial megaprostheses supported with iodine.
Shirai, T, Tsuchiya, H, Nishida, H, Yamamoto, N, Watanabe, K, Nakase, J, Terauchi, R, Arai, Y, Fujiwara, H, Kubo, T
Journal of biomaterials applications. 2014;(4):617-23
Abstract
Deep infection associated with implants remains a serious complication of orthopedic surgery. We developed iodine coating for titanium implants. In this study, we performed a clinical trial of iodine-coated megaprostheses to evaluate its safety and antibacterial effects. Forty-seven patients with malignant bone tumor or pyogenic arthritis were treated using iodine-supported titanium megaprostheses between July 2008 and May 2013. The mean age was 53.6 years (range, 15-85 years). Twenty-six patients were males and 21 were females. The diagnoses included malignant bone tumor in 29 cases, infected total knee arthroplasty in 11 cases, chronic osteomyelitis due to pyogenic arthritis in six cases and loosening of total knee arthroplasty in one case. The iodine-supported implants used were 42 Kyocera Limb Salvage System and five KOBELCO K-MAX K-3. These megaprostheses were used to prevent infection in 21 patients, treat active infections in 26 patients. The mean follow-up period was 30.1 months (range, 8-50). Infection was prevented in 20 out of 21 patients. Only one patient had surgical site infection caused by Pseudomonas aeruginosa and was cured by intravenous administration of antibiotics alone without removal of the implant. In 26 treatment cases involving one- or two-stage revision surgery, infection subsided without any additional surgery. In all cases, there were no signs of infection at the time of the last follow-up. White blood cell and C-reactive protein levels returned to normal within four weeks after surgery. To confirm systemic effects of iodine, thyroid hormone levels in the blood were examined. Abnormalities of thyroid gland function were not detected. Loosening of the implants was not observed. Excellent bone ingrowth and ongrowth were found around iodine-supported megaprostheses. The iodine-supported titanium megaprostheses are highly effective and show promise for the prevention and treatment of infections in large bone defects. No cytotoxicity or adverse effects were detected with this treatment.
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Chlorhexidine for the prevention of bloodstream infection associated with totally implantable venous ports in patients with solid cancers.
Kao, HF, Chen, IC, Hsu, C, Chang, SY, Chien, SF, Chen, YC, Hu, FC, Yang, JC, Cheng, AL, Yeh, KH
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2014;(5):1189-97
Abstract
PURPOSE To evaluate the preventive effects of topical skin disinfection with chlorhexidine on bloodstream infection (BSI) associated with totally implantable venous port (Port-A). METHODS Two consecutive cohorts of solid cancer patients were prospectively followed for the occurrence of Port-A associated BSI (PABSI). The first cohort used povidone-iodine as topical skin disinfection and the second cohort used chlorhexidine. The primary endpoint was the time to first PABSI. Propensity score analysis was applied. The preventive effects of chlorhexidine were analyzed by Cox proportional hazards models. RESULTS There were 396 patients (81,752 catheter-days) in the iodine cohort and 497 (99,977 catheter-days) in the chlorhexidine cohort. Gram-negative bacteria were the most common pathogens to cause first episode of PABSI (iodine cohort (I) vs chlorhexidine cohort (C) and 0.404 vs 0.450 per 1,000 catheter-day), followed by Gram-positive bacteria (I vs C and 0.269 vs 0.110 per 1,000 catheter-day), and fungi (I vs C and 0.098 vs 0.070 per 1,000 catheter-day). Three hundred forty-three patients were selected from each cohort by propensity score match analysis. Chlorhexidine use was associated with a significant improvement on time to first PABSI caused by Gram-positive bacteria (log-rank test, p=0.00175; HR=0.35, 95 % CI, 0.14-0.85, p=0.02). No significant preventive effects of chlorhexidine on time to first PABSI caused by Gram-negative bacteria or fungi was found. CONCLUSIONS Chlorhexidine topical skin disinfection may prevent PABSI caused by Gram-positive bacteria in patients with solid cancers. The nonsignificant effect on preventing overall PABSI may be attributed to the high incidence of Gram-negative bacteria related PABSI.
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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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A combination povidone-iodine 0.4%/dexamethasone 0.1% ophthalmic suspension in the treatment of adenoviral conjunctivitis.
Pelletier, JS, Stewart, K, Trattler, W, Ritterband, DC, Braverman, S, Samson, CM, Liang, B, Capriotti, JA
Advances in therapy. 2009;(8):776-83
Abstract
INTRODUCTION The objective of this pilot study was to determine the preliminary efficacy of a novel ophthalmic suspension containing povidone-iodine 0.4% and dexamethasone 0.1% in the treatment of adenoviral conjunctivitis. METHODS A prospective, open-label, single-armed, phase II clinical trial in humans. Eligible patients with the clinical signs and symptoms of acute conjunctivitis who tested positive for adenoviral antigen by Rapid Pathogen Screening (RPS) Adeno Detector were enrolled in a single treatment arm consisting of a combination povidone-iodine 0.4%/dexamethasone 0.1% sterile ophthalmic suspension given four times daily for a minimum of 5 days. RPS Adeno Detector testing was performed at baseline and at each follow-up visit along with ocular fluid sampling by conjunctival swabs. Subsequent analysis performed on all swabs included both adenoviral titer by quantitative polymerase chain reaction (qPCR) and cell culture with confirmatory immunofluorescence (CC-IFA). The primary endpoint was clinical resolution of conjunctival injection and discharge. Secondary measures included reduction of qPCR titers and eradication of infectious virus as determined by CC-IFA. RESULTS A total of nine eyes of six patients with clinical signs and symptoms of acute viral conjunctivitis and a positive RPS Adeno Detector test result were enrolled in the study. In eight/nine eyes enrolled in the study, clinical resolution was observed by day 3 or day 4. In six/six eyes with detectable adenovirus by qPCR, significant reduction in viral titer was seen by day 3, day 4, or day 5. In five/six eyes with infectious virus confirmed by CC-IFA at enrollment, elimination of infectivity was achieved by day 4 or day 5. One patient was lost to followup. CONCLUSIONS An ophthalmic suspension containing povidone-iodine 0.4% and dexamethasone 0.1% may be a useful agent in the treatment of acute RPS Adeno Detector-positive conjunctivitis. A further placebo-controlled study with a larger number of patients is warranted.
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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 randomized trial that compared povidone iodine and chlorhexidine as antiseptics for vaginal hysterectomy.
Culligan, PJ, Kubik, K, Murphy, M, Blackwell, L, Snyder, J
American journal of obstetrics and gynecology. 2005;(2):422-5
Abstract
OBJECTIVE The purpose of this study was to compare the efficacy of chlorhexidine and povidone iodine for cleansing the operative field for vaginal surgery. STUDY DESIGN This was a randomized controlled trial that compared 10% povidone iodine and 4% chlorhexidine gluconate as surgical scrubs. Our primary end point was the proportion of contaminated specimens (defined as total bacterial colony counts of ≥5000 colony-forming units) per group found throughout the surgical procedures. All patients received standard infection prophylaxis that included preoperative intravenous antibiotics. Immediately before antibiotic administration and baseline aerobic and anaerobic cultures of the vaginal flora were obtained, which were followed by cultures at 30 minutes after the surgical scrub and hourly thereafter throughout each patient's surgery. RESULTS A total of 50 patients were enrolled between October 2002 and September 2003. There were no differences between the povidone iodine (n = 27) and chlorhexidine (n = 23) groups with respect to age, race, exogenous hormone use, body mass index, gravity, parity, preoperative mean colony counts, or operative time. Among the first set of intraoperative specimens (which were obtained 30 minutes after the surgical scrub), 63% of the cultures (17/27) from the povidone iodine group and 22% of the cultures (5/23) from the chlorhexidine group were classified as contaminated ( P = .003; relative risk, 6.12; 95% CI, 1.7, 21.6). Subsequent cultures failed to demonstrate significant differences. CONCLUSION Chlorhexidine gluconate was more effective than povidone iodine in decreasing the bacterial colony counts that were found in the operative field for vaginal hysterectomy.
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A study into the plaque-inhibitory activity of experimental toothpaste formulations containing antimicrobial agents.
Moran, J, Newcombe, RG, Wright, P, Haywood, J, Marlow, I, Addy, M
Journal of clinical periodontology. 2005;(8):841-5
Abstract
BACKGROUND/AIMS: The use of specific antimicrobial agents in toothpastes may help reduce plaque and gingivitis. There would also appear to be some value in formulating products that contain combinations of such agents that may potentiate any activity present. The aims of this exploratory and pragmatic study were twofold: (1) Exploratory: to compare the effects on plaque re-growth of two zinc citrate/triclosan formulations, one of which contained bromochlorophene and hence demonstrate any additional beneficial effects produced by the addition of the phenol. (2) Pragmatic: to assess whether both pastes were significantly better than a benchmark control, proprietary fluoride toothpaste at inhibiting plaque formation. METHODS Following an initial prophylaxis to remove all plaque and calculus, toothpaste slurry rinses were used over a 96 h period by 24 volunteers, while omitting all other oral hygiene procedures. After 24, 48 and 96 h, plaque was measured by plaque area and by plaque index. For comparative purposes, a conventional commercial fluoride toothpaste rinse was also used as a benchmark control in this triple cross-over double-blind study. RESULTS With one exception, comparisons between the three pastes failed to show any significant differences in plaque accumulation at 96 h whether assessed by plaque index or area. At this time period, significantly more plaque was seen with the zinc citrate paste without bromochlorophene, compared with that of the control paste. CONCLUSIONS The findings from this study failed to demonstrate a plaque-inhibitory action from the two novel formulations beyond that of a conventional benchmark toothpaste, although overall levels of plaque formed by the volunteers, especially on the control paste were generally lower than in previous studies. Nevertheless, it remains to be determined whether the test formulations could exert a direct anti-inflammatory action against gingivitis by way of the triclosan delivery system. Neither test formulation was subsequently marketed.