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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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Aqueous olanexidine versus aqueous povidone-iodine for surgical skin antisepsis on the incidence of surgical site infections after clean-contaminated surgery: a multicentre, prospective, blinded-endpoint, randomised controlled trial.
Obara, H, Takeuchi, M, Kawakubo, H, Shinoda, M, Okabayashi, K, Hayashi, K, Sekimoto, Y, Maeda, Y, Kondo, T, Sato, Y, et al
The Lancet. Infectious diseases. 2020;(11):1281-1289
Abstract
BACKGROUND Surgical site infection (SSI) is the most common problem after surgery. Although several guidelines have indicated the efficacy of antiseptics, such as chlorhexidine-alcohol and povidone-iodine, in reducing SSI rate, the optimal recommendation is still not established. Olanexidine might have higher bactericidal activity than other antiseptic agents. However, no randomised study has evaluated the efficacy and safety of olanexidine over conventional antiseptics. We compared the effect of aqueous olanexidine and aqueous povidone-iodine on the incidence of SSI following clean-contaminated surgery. METHODS This was a multicentre, prospective, randomised, blinded-endpoint superiority trial for surgical skin antisepsis in clean-contaminated gastrointestinal and hepatobiliary pancreatic surgeries in four Japanese hospitals. Patients aged 20 years or older who underwent elective clean-contaminated wound surgery were randomly assigned in a 1:1 replacement ratio using a computer-generated block randomisation. Patients were randomly assigned to surgical skin antisepsis with an aqueous formulation of 1·5% olanexidine or surgical skin antisepsis with an aqueous formulation of 10% povidone-iodine before surgery. We used olanexidine in a ready-to-use applicator, and povidone-iodine was administered by a brush or by compression using pliers. Both antiseptics were applied from the papilla with a cranial limit and to the upper thigh with a caudal limit. The antiseptics were allowed to dry for 3 min, and then surgery started. Participants, some investigators, and data analysts were masked to treatment allocation. Participant enrolment was done by non-masked investigators. The primary outcome was 30-day SSI assessed in the intention-to-treat population. The surgical wound site of each participant was observed daily. After discharge, participants underwent at least one outpatient visit within 30 days after surgery. This trial is registered with University hospital Medical Information Network, 000031560. FINDINGS Between June 10, 2018, and April 18, 2019, 883 patients were assessed for eligibility. 587 patients were eligible and 294 received olanexidine and 293 received aqueous povidone-iodine before surgery. 30-day SSI occurred in 19 (7%) patients in the olanexidine group and 39 patients (13%) patients in the povidone-iodine group (adjusted risk difference -0·069; 90% CI -0·109 to -0·029; adjusted risk ratio [RR] 0·48, 90% CI 0·30 to 0·74; p=0·002). Five patients (2%) in the olanexidine group and five (2%) in the povidone-iodine group developed adverse skin reactions (adjusted RR 0·99, 95% CI 0·29 to 3·40; p=1·00). INTERPRETATION Olanexidine significantly reduced the occurrence of overall SSI and superficial incisional SSI compared with aqueous povidone-iodine in clean-contaminated surgery. Our results indicate that olanexidine might have a role to prevent SSI in patients who undergo clean-contaminated surgeries. FUNDING Keio University and Ohyama Health Foundation.
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Control of post-hemorrhoidectomy symptoms and wound healing by Triclosan: a randomized, double-blind, controlled trial.
Giannini, I, Pecorella, G, Pennisi, D, Santangelo, G, Digennaro, R, Latorre, F, Giuliani, G, Altomare, DF
Minerva chirurgica. 2014;(2):75-82
Abstract
AIM: Milligan-Morgan hemorrhoidectomy (MM) is still the most common treatment for grades III and IV hemorrhoids despite prolonged post-operative anal pain and wound healing. This multicenter, double blind, randomized, controlled trial was designed to assess the safety and the efficacy of anal wound cleansing with Triclosan (Proctocid®) in the control of symptoms and healing time after MM. METHODS A total of 113 patients with grades III and IV hemorrhoids, undergoing open hemorroidectomy by diathermy or Ligasure vessel sealing device, were randomly assigned to Triclosan or sodium hypochlorite solution. All patients received analgesics and a fiber-rich diet after hemorrhoidectomy. Postoperative anal pain, bleeding and/or secretion and itch were assessed 7, 14 and 21 days after hemorrhoidectomy by a Visual Analogue Scale (VAS) and the day of complete re-epithelialization of anal wounds was recorded. RESULTS Fifty-five patients were randomized for Triclosan treatment and 58 for the control drug. The two groups were comparable for demographics, severity of hemorrhoids and technique used for the hemorrhoidectomy. The comparison of days to get complete anal wound healing shows a trend of significance (P=0.05) for the Triclosan group. Bleeding and/or secretion, anal pain and itch were significantly better (P=0.003; P<0.0001 and P=0.01, respectively). CONCLUSION Triclosan solution for the treatment of post-hemorrhoidectomy wounds is safe and improves the control of post-operative symptoms and wound healing time compared to sodium hypochlorite.
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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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Controlling systematic perioperative anaerobic contamination during sinus-lift procedures by using metronidazole: an innovative approach.
Choukroun, J, Simonpieri, A, Del Corso, M, Mazor, Z, Sammartino, G, Dohan Ehrenfest, DM
Implant dentistry. 2008;(3):257-70
Abstract
BACKGROUND AND OBJECTIVES Analysis of tomodensitometric controls following sinus grafts clearly demonstrates a quite systematic lack of homogeneity. Sinus contamination by anaerobic bacteria seems almost unavoidable during bone graft surgery, and this problem may jeopardize the healing process. The aim of this study was to characterize in a systematic way the nonhomogeneities observed at 1, 2, or 3 months postsurgery within allogenous sinus grafts, and to assess the possible influence of a 0.5% sterile solution of metronidazole incorporated in the sinus bone graft. MATERIALS This clinical study was conducted on 72 patients treated with single or bilateral sinus-lifts: 94 sinus elevations performed with freeze-dried bone allograft (Phoenix, TBF, Mions, France), with (test group) or without (control group) metronidazole. In the test group, each bone graft was hydrated with 2 mL of a 0.5% metronidazole solution, i.e., only 10 mg of metronidazole. All the patients went through a first presurgical computerized tomography (CT)-scan followed by a second scan performed at 1, 2, or 3 months postsurgery (which was used as the preimplant reference scan). For 11 patients, 2 postsurgical CT-scans were performed respectively at 10 days and 2 months. Using an arbitrary gray scale (Arbitrary Densitometric Unit) which functions according to the Hounsfield unit principle, the degree of radiographic homogeneity of the grafts was established. Density scattering provides some information on the homogeneity or nonhomogeneity of the bone graft. RESULTS The 12 grafts performed without metronidazole show significant nonhomogeneities at 1, 2, or 3 months. Moreover, when a CT-scan is performed during the first postoperative days (at 10 days), the presence of air bubbles in the graft is confirmed. The tomodensitometric aspects of all grafts treated with metronidazole in this series are absolutely identical: they show a high degree of homogeneity. Sixty-three cases (76.8%) are homogeneous, and 19 cases (23.2%) are significantly homogeneous. The time at which the control scan is performed (10 days, 1, 2, or 3 months) does not seem to influence significantly the degree of homogeneity assessed. In the control group, some inflammatory events associated with facial oedema were observed in 25% of the cases. In the test group, no such event was recorded for the 82 sinus-lifts treated with metronidazole. CONCLUSION A possible correlation may exist between the occurrence of non homogeneities within the bone grafts and the anaerobic bacterial contamination. The local use of a very small quantity of metronidazole (equivalent to only 1/20 of a common 200 mg oral tablet) could provide more security when performing sinus-lift procedures and an improved quality of the graft. This protocol should not be considered as an antibiotherapy, but only as way to limit the initial contamination of bone graft.
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Povidone-iodine vs sodium hypochlorite enema for mechanical preparation before elective open colonic or rectal resection with primary anastomosis: a multicenter randomized controlled trial.
Valverde, A, Msika, S, Kianmanesh, R, Hay, JM, Couchard, AC, Flamant, Y, Fingerhut, A, Fagniez, PL, ,
Archives of surgery (Chicago, Ill. : 1960). 2006;(12):1168-74; discussion 1175
Abstract
HYPOTHESIS The anti-infective actions of povidone-iodine (PVI) and sodium hypochlorite enemas are different. DESIGN Prospective, randomized, single-blind study. SETTING Multicenter. PATIENTS Five hundred seventeen consecutive patients with colorectal carcinoma or sigmoid diverticular disease undergoing elective open colorectal resection, followed by primary anastomosis. INTERVENTION All patients received senna (1-2 packages diluted in a glass of water) at 6 pm the evening before surgery. Patients were administered two 2-L aqueous enemas of 5% PVI (n = 277) or 0.3% sodium hypochlorite (n = 240) at 9 pm the evening before surgery and at 3 hours before operation. Intravenous ceftriaxone sodium (1 g) and metronidazole (1 g) were administered at anesthetic induction. MAIN OUTCOME MEASURE Rate of patients with 1 infective parietoabdominal complication or more. RESULTS The percentages of patients with 1 infective parietoabdominal complication or more did not differ between the 2 groups (13.7% in the PVI-treated group vs 15.0% in the sodium hypochlorite-treated group). Tolerance was better in the PVI-treated group than in the sodium hypochlorite-treated group (79.4% vs 67.9%), with fewer patients experiencing abdominal pain (13.0% vs 24.6%) or discontinuing their preparation (3.0% vs 9.0%) (P=.02 for all). There were more patients with malaise in the PVI-treated group than in the sodium hypochlorite-treated group (9.1% vs 4.9%, P<.05). Three patients in the sodium hypochlorite-treated group had necrotic ulcerative colitis. CONCLUSION When antiseptic enemas are chosen for mechanical preparation before colorectal surgery, PVI should be preferred over sodium hypochlorite because of better tolerance and avoidance of necrotic ulcerative colitis.