Antimicrobial Activity of a Triple Antibiotic Combination Toward Ocular Pseudomonas aeruginosa Clinical Isolates.

Purpose: Pseudomonas aeruginosa is a leading cause of corneal infections. Recently, we discovered an antimicrobial drug combination, polymyxin B/trimethoprim (PT) + rifampin, that displayed impressive efficacy toward P. aeruginosa in both in vitro and in vivo studies. As such, this combination was further evaluated as a potential keratitis therapeutic through testing the combination's efficacy against a diverse set of P. aeruginosa clinical isolates. Methods: Minimum inhibitory concentrations (MICs) of moxifloxacin, levofloxacin, erythromycin, tobramycin, PT, polymyxin B (alone), trimethoprim (alone), and rifampin were determined for 154 ocular clinical P. aeruginosa isolates, 90% of which were derived from corneal scrapings. Additionally, the efficacy of PT + rifampin was evaluated utilizing fractional inhibitory concentration (FIC) testing. Results: While 100% of isolates were resistant to erythromycin (average MIC 224 ± 110 µg·mL-1) and trimethoprim (alone) (206 ± 67.3 µg·mL-1), antibiotic resistance was generally found to be low: moxifloxacin (2% of isolates resistant; average MIC 1.08 ± 1.61 µg·mL-1), levofloxacin (3.9%; 1.02 ± 2.96 µg·mL-1), tobramycin (1%; 0.319 ± 1.31 µg·mL-1), polymyxin B (0%; 0.539 ± 0.206 µg·mL-1), PT (0%; 0.416 ± 0.135 µg·mL-1), and rifampin (0%; 23.4 ± 6.86 µg·mL-1). Additionally, FIC testing revealed that PT + rifampin eradicated 100% of isolates demonstrating additive or synergistic activity in 95% of isolates (average FIC index 0.701 ± 0.132). Conclusions: The drug combination of PT + rifampin was effective against a large panel of clinically relevant P. aeruginosa strains and, as such, may represent a promising therapeutic for P. aeruginosa keratitis. Translational Relevance: This work furthers the preclinical development of a novel antibiotic combination for the treatment of corneal infections (bacterial keratitis).

Sub-chronic 90-day toxicity of neamine in SD rats and its anti-liver cancer activity in vitro and in vivo.

Neamine, an inhibitor of angiogenin (ANG), is a new investigative anticancer drug currently in preclinical stage. Here we report the 90-day sub-chronic toxicity of neamine in SD rats and its anti-liver cancer activity in vitro and in vivo. Neamine has a No Observed Adverse Effect Level (NOAEL) of 12 and 16mg·kg-1·d-1 for female and male rats, respectively. No mortality was found. The adverse effects included increased organ coefficients of spleen and kidney, increased BUN in both female and male rats at high dose, increased CR and decreased organ coefficients of heart and liver in male rats at high dose. All of which, except the kidney coefficient and BUN in males, returned to normal levels after 28-day recovery. Histopathological examination revealed vacuolar degeneration of glomerulus, degeneration of renal tubules and cast in the kidneys, which were also recovered except in males of high-dosing group. These results indicate that kidney is the most susceptible organ for neamine toxicity. Tissue microarray analysis validated that ANG is up-regulated in hepatocellular carcinoma accompanied by increased nuclear translocation, suggesting that ANG is a possible target for drug development in liver cancer treatment. Neamine blocked nuclear translocation of ANG in HUVEC and HepG2 cells, and inhibited ANG-stimulated cell proliferation without affecting basal level cell proliferation. Neamine also inhibited progression of HepG2 xenografts in athymic mice accompanied by decreased angiogenesis and cancer cell proliferation. These results suggest that neamine is a specific ANG inhibitor with low toxicity and high anti-liver cancer efficacy.

Multidisciplinary care of a paediatric patient with Gradenigo's syndrome.

A 10-year-old girl presented with signs and symptoms suggestive of Gradenigo's syndrome, a condition characterised by otorrhoea, diplopia due to abducens nerve palsy and pain in the region of the trigeminal nerve. This case examines the presentation of this condition, and the appropriate investigations. We also highlight the importance of the involvement of multiple specialities in discussing and devising a suitable management plan.

Neamine inhibits growth of pancreatic cancer cells in vitro and in vivo.

Neamine, a non-toxic derivative of neomycin, has recently been shown to have antitumor activities in various types of cancers. However, its effect on pancreatic cancer is still unknown. The study aimed to investigate its antitumor activity on pancreatic cancer and the underlying mechanisms. MTT assay was used to observe the effect of neamine on angiogenin (ANG)-induced AsPC-1 cell proliferation. Tissue microassay and immunofluorescence staining were used to detect the expression of ANG and its nuclear translocation, respectively. Tumor xenografts were established by subcutaneous inoculation of AsPC-1 pancreatic cancer cells into the right flanks of nude mice, and neamine was injected subcutaneously. Immunohistochemistry was done to observe the expression of ANG, CD31 and Ki-67 in tumor xenografts. It was found that neamine blocked the nuclear translocation of ANG effectively and inhibited ANG-induced AsPC-1 cell proliferation in a dose-dependent manner. Neamine had anti-tumor effects on AsPC-1 xenograft models. Consistently, neamine reduced the expression levels of ANG, Ki-67 and CD31 in tumor xenografts. It was concluded that neamine may be a promising agent for treatment of pancreatic cancer.

Neamine induces neuroprotection after acute ischemic stroke in type one diabetic rats.

INTRODUCTION: Angiogenin is a member of the ribonuclease superfamily and promotes degradation of the basement membrane and the extracellular matrix. After stroke in type one diabetes (T1DM) rats, Angiogenin is significantly increased and the Angiogenin is inversely correlated with functional outcome. Neamine, an aminoglycoside antibiotic, blocks nuclear translocation of Angiogenin, thereby abolishing the biological activity of Angiogenin. In this study, we therefore investigated the effect and underlying protective mechanisms of Neamine treatment of stroke in T1DM. METHODS: T1DM was induced in male Wistar rats by streptozotocin (60mg/kg, ip), and T1DM rats were subjected to embolic middle cerebral artery occlusion (MCAo). Neamine (10mg/kg ip) was administered at 2, 24 and 48h after the induction of embolic MCAo. A battery of functional outcome tests was performed. Blood-brain barrier (BBB) leakage, and lesion volume were evaluated and immunostaining, and Western blot were performed. RESULTS: Neamine treatment of stroke in T1DM rats significantly decreased BBB leakage and lesion volume as well as improved functional outcome compared to T1DM-control. Neamine also significantly decreased apoptosis and cleaved caspase-3 in the ischemic brain. Using immunostaining, we found that Neamine treatment significantly decreased nuclear Angiogenin, nuclear factor kappa-light-chain-enhancer of activated B cells (NFκB) activity, advanced glycation endproducts receptor (RAGE) number, the positive area of toll-like receptor 4 (TLR4) and increased Angeopoietin-1 expression compared to T1DM-MCAo control rats. Western blot results are consistent with the immunostaining. CONCLUSION: Neamine treatment of stroke is neuroprotective in T1DM rats. Inhibition of neuroinflammatory factor expression and decrease of BBB leakage may contribute to Neamine-induced neuroprotective effects after stroke in T1DM rats.

Decolonization of intestinal carriage of extended-spectrum ß-lactamase-producing Enterobacteriaceae with oral colistin and neomycin: a randomized, double-blind, placebo-controlled trial.

OBJECTIVES: Extended-spectrum ß-lactamase-producing Enterobacteriaceae (ESBL-E) are an increasingly frequent cause of infections in the community and the healthcare setting. In this study, we aimed to investigate whether intestinal carriage of ESBL-E can be eradicated. METHODS: We conducted a double-blind, randomized, placebo-controlled, single-centre trial to assess the efficacy of an oral decolonization regimen on intestinal ESBL-E carriage in adult patients with an ESBL-E-positive rectal swab. Fifty-eight patients were allocated 1 : 1 to either placebo or colistin sulphate (50 mg 4×/day) and neomycin sulphate (250 mg 4×/day) for 10 days plus nitrofurantoin (100 mg 3×/day) for 5 days in the presence of ESBL-E bacteriuria. The primary outcome was detection of ESBL-E by rectal swab 28 ± 7 days after the end of treatment. Missing primary outcome data were imputed based on the last available observation. Additional cultures (rectal, inguinal and urine) were taken on day 6 of treatment and on days 1 and 7 post-treatment. The study protocol has been registered with ClinicalTrials.gov (NCT00826670). RESULTS: Among 54 patients (27 in each group) included in the primary analysis, there was no statistically significant difference between the groups with regard to the primary outcome [14/27 (52%) versus 10/27 (37%), P = 0.27]. During treatment and shortly afterwards, there was significantly lower rectal ESBL-E carriage in the treatment group: 9/26 versus 19/22 on day 6 of treatment (P < 0.001) and 8/25 versus 20/26 on day 1 post-treatment (P = 0.001). This effect had disappeared by day 7 post-treatment (18/27 versus 17/25, P = 0.92). Liquid stools were more common in the treatment group (7/27 versus 2/29, P = 0.05). CONCLUSIONS: The regimen used in this study temporarily suppressed ESBL-E carriage, but had no long-term effect.

Anterior cervical discectomy, drainage and non-instrumented cortico-cancellous allograft fusion: a treatment option for ventral cervical spinal epidural abscess.

INTRODUCTION: Ventral cervical spinal epidural abscess is a very rare clinical condition with a relatively high morbidity and mortality. Due to the paucity of reported cases there is heterogeneity and no clear "gold standard" in the treatment of these patients. OBJECTIVE: The authors report four consecutive patients with ventral cervical spinal epidural abscess treated with anterior cervical discectomy, abscess drainage and original non-instrumented cortico-cancellous allograft spinal fusion. METHODS: The authors retrospectively reviewed a series of four patients treated for ventral cervical epidural spinal abscess. All patients were treated with an urgent operation. Anterior cervical discectomy, abscess drainage, and non-instrumented cortico-cancellous allograft spinal fusion followed by cervical immobilization and systemic antibiotic treatment were utilized. RESULTS: The bone fusion occurred within a mean of 3.5 months of follow-up. No significant radiologic or clinical evidence of graft subsidence was noted after a minimum of 2.5 years follow-up. All patients resolved infection and were neurologically intact. No complications of treatment were noted. CONCLUSION: Urgent operative treatment with anterior cervical discectomy, abscess drainage and non-instrumented cortico-cancellous allograft spinal fusion, followed by immobilization and the appropriate systemic antibiotic treatment is an effective original modification for the treatment and resolution of ventral cervical epidural spinal abscess.

Facial necrotizing fasciitis from an odontogenic infection.

Necrotizing fasciitis (NF) is defined as rapidly progressive necrosis of subcutaneous fat and fascia. It is a rare but life-threatening infection characterized by a progressive, usually rapid, necrotizing process of the subcutaneous tissues and fascial planes. The condition is commonly described in the extremities, abdominal wall, and perineum but rarely seen in the head and neck. The diagnosis of NF depends mainly on clinical features, which are not always observable, so that the disease is often diagnosed late in its course, resulting in high mortality. Broad-spectrum antibiotics, aggressive surgical treatment and supportive therapy are the most widely accepted modalities of successful treatment. We describe a case of necrotizing fasciitis of the head and neck, arising from odontogenic origin.

Aloe vera for treating acute and chronic wounds.

BACKGROUND: Aloe vera is a cactus-like perennial succulent belonging to the Liliaceae Family that is commonly grown in tropical climates. Animal studies have suggested that Aloe vera may help accelerate the wound healing process. OBJECTIVES: To determine the effects of Aloe vera-derived products (for example dressings and topical gels) on the healing of acute wounds (for example lacerations, surgical incisions and burns) and chronic wounds (for example infected wounds, arterial and venous ulcers). SEARCH METHODS: We searched the Cochrane Wounds Group Specialised Register (9 September 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 3), Ovid MEDLINE (2005 to August Week 5 2011), Ovid MEDLINE (In-Process & Other Non-Indexed Citations 8 September 2011), Ovid EMBASE (2007 to 2010 Week 35), Ovid AMED (1985 to September 2011) and EBSCO CINAHL (1982 to 9 September 2011). We did not apply date or language restrictions. SELECTION CRITERIA: We included all randomised controlled trials that evaluated the effectiveness of Aloe vera, aloe-derived products and a combination of Aloe vera and other dressings as a treatment for acute or chronic wounds. There was no restriction in terms of source, date of publication or language. An objective measure of wound healing (either proportion of completely healed wounds or time to complete healing) was the primary endpoint. DATA COLLECTION AND ANALYSIS: Two review authors independently carried out trial selection, data extraction and risk of bias assessment, checked by a third review author. MAIN RESULTS: Seven trials were eligible for inclusion, comprising a total of 347 participants. Five trials in people with acute wounds evaluated the effects of Aloe vera on burns, haemorrhoidectomy patients and skin biopsies. Aloe vera mucilage did not increase burn healing compared with silver sulfadiazine (risk ratio (RR) 1.41, 95% confidence interval (CI) 0.70 to 2.85). A reduction in healing time with Aloe vera was noted after haemorrhoidectomy (RR 16.33 days, 95% CI 3.46 to 77.15) and there was no difference in the proportion of patients completely healed at follow up after skin biopsies. In people with chronic wounds, one trial found no statistically significant difference in pressure ulcer healing with Aloe vera (RR 0.10, 95% CI -1.59 to 1.79) and in a trial of surgical wounds healing by secondary intention Aloe vera significantly delayed healing (mean difference 30 days, 95% CI 7.59 to 52.41). Clinical heterogeneity precluded meta-analysis. The poor quality of the included trials indicates that the trial results must be viewed with extreme caution as they have a high risk of bias. AUTHORS' CONCLUSIONS: There is currently an absence of high quality clinical trial evidence to support the use of Aloe vera topical agents or Aloe vera dressings as treatments for acute and chronic wounds.

Evaluation of wound-healing formulation against sulphur mustard-induced skin injury in mice.

Sulphur mustard (SM) is a bifunctional alkylating agent that causes cutaneous blisters in human and animals. Remedies to SM-induced dermatotoxicity are still in experimental stage. Due to inevitable requirement of a wound-healing formulation against SM-induced skin lesions, efficacy of formulations including povidone iodine, Aloe vera gel, betaine or framycetin sulphate was evaluated in present study. SM was applied percutaneously (5 mg/kg) once on back region of Swiss albino mice; and after 24 hours, DRDE/WH-02 (Defence Research and Development Establishment/ Wound Healant- 02, containing polyvinylpyrrolidone [PVP], A. vera gel and betaine), Ovadine, Soframycin or A. vera gel were applied topically, daily for 3 or 7 days in different groups. Skin sections were subjected to histopathology, histomorphologic grading, tissue leukocytosis, terminal deoxynucleotidyl transferase dUTP nick end labelling (TUNEL) assay and immunohistochemistry of inflammatory-reparative biomarkers. DRDE/WH-02 treated mice received highest score on the basis of histomorphologic scale and lowest number of TUNEL-positive cells compared to other groups. DRDE/WH-02 showed better wound healing as evidenced by widespread re-epithelialization, homogenous fibroplasias well supported by the expression of transforming growth factor-α, endothelial nitric oxide synthase (eNOS) and fibroblast growth factor. Upregulation of interleukin 6 in DRDE/WH-02-treated mice skin resulted in increased tissue leukocytosis and an early removal of tissue debris that initiated reparative process at faster rate compared to other groups. In conclusion, DRDE/WH-02 provided better healing effect and can be recommended as an effective wound healant against SM-induced skin injury.

Risk factors associated with bacteriological cure, new infection, and incidence of clinical mastitis after dry cow therapy with three different antibiotics.

Factors affecting bacteriological cure rates (BCR) and new intramammary infections (IMI) during the dry period as well as clinical mastitis (CM) during early lactation were investigated in 414 German Holstein dairy cows receiving dry cow therapy. Cows were treated with either benethamine benzylpenicillin (300,000 IU), penethamate hydriodide (100,000 IU), and framycetin sulphate (100 mg, n = 136), or cefquinome (150 mg, n = 135), or benzathine cloxacillin (1,280 mg, n = 143). Overall BCR, IMI, and CM at parturition were 86.4%, 20.7%, and 4.3%, respectively. The three antibiotic treatments differed only in BCR, with cloxacillin yielding better results than the others. Udder quarters from cows with > 4 lactations had a higher risk of IMI and CM at calving. Chronic changes in udder tissues were linked to a lower BCR and were associated with a higher risk of CM during early lactation. The risk of CM at calving was higher in udder quarters with unspecific or subclinical mastitis before drying off. In conclusion, with antibiotic dry cow therapy, age and health status of the udder appear to be major determinants of IMI and CM during the dry period and early lactation, while BCR was associated with the antibiotic type and udder tissue status.

The effect of dry cow therapy and internal teat-sealant on intra-mammary infections during subsequent lactation.

Dry cow therapy (DCT), an infusion of antibiotics into the mammary gland at the end of lactation, is widely used for the control of intra-mammary infections (IMI) in the dairy cow. However, increased public health concerns about the use of antibiotics, has led to the search for alternatives to the routine use of antibiotics during drying off. In the present study the effects of three dry cow treatments, two types of DCT and a teat-sealant, on the development of new IMI and clinical mastitis were investigated in 240 cows belonging to two herds (Herd A and Herd B). In Herd A, 60 cows were given one type of DCT (Cloxacillin) and the other 60 cows were given another type of DCT (Framycetin). In Herd B, 60 cows were given teat-sealant and the other herd were not given any treatment. There were significantly more new IMI at calving in control cattle compared to those given teat-sealants (p<0.001) and there were more cases of clinical cases of mastitis in the control group. The number of clinical cases detected in cows given teat-sealant in Herd B were not significantly different from those detected in cows in Herd A given Cloxacillin or Framycetin.

A prospective double-blinded comparative analysis of framycetin and silver sulphadiazine as topical agents for burns: a pilot study.

Burn wound sepsis remains the leading cause of mortality if conservative methods of wound management are employed. Topical agents are still the mainstay of such wound management in the developing world. Non availability of agents like Mafenide or silver ion dressings in the developing world due to corporate strategies or cost concerns necessitates a search for alternatives to silver sulphadiazine, which is the gold standard. We report the use of framycetin 1% cream (Soframycin) in 20 patients of major burns (ranging from 15% to 40% TBSA), and in a double blinded study quantitatively comparing the bacterial load on day 4 and day 7 with a group of similar patients in whom silver sulphadiazine was used. The age group of the 40 patients was 10-50 years and they were without any co-morbid condition. All bacterial isolates from the 40 patients were also tested for framycetin sensitivity. Serial kidney function tests were done on all patients, and patients in the framycetin group underwent an audiometric testing at a mean time of 28 days. All results were statistically analyzed. It was noted that there was no statistically significant difference in the colony counts on days 4 and 7 between the two groups. As a corollary, it was also evident that there was no statistically significant difference in the rise in colony counts from day 4 to day 7 in the two groups. Sixty-four percent of all bacterial isolates were sensitive to framycetin, although, this could not be compared with sensitivity to silver sulphadiazine. It was not possible to do assays for framycetin levels in blood but no patient developed nephrotoxicity or ototoxicity with its use. According to our pilot study results framycetin appears to be an alternative to silver suphadiazine as a topical agent for major burns. Framycetin application is also painless and it leads to no discoloration of the wound.

Topical ciprofloxin versus topical framycetin-gramicidin-dexamethasone in Australian aboriginal children with recently treated chronic suppurative otitis media: a randomized controlled trial.

BACKGROUND: Chronic suppurative otitis media (CSOM) affects many children in disadvantaged populations. The most appropriate topical antibiotic treatment in children with persistent disease is unclear. METHODS: Children with CSOM despite standard topical treatment were randomized to 6-8 weeks of topical ciprofloxacin (CIP) versus topical framycetin-gramicidin-dexamethasone (FGD). Otoscopic, audiologic, and microbiologic outcomes were measured using standardized assessments and blinding. RESULTS: Ninety-seven children were randomized. Ear discharge failed to resolve at the end of therapy in 70% children regardless of allocation [risk difference = -2%; (95% CI: -20 to 16)]. Healing of the tympanic membrane occurred in one of 50 children in the CIP group and none of 47 children in the FGD group. Severity of discharge failed to improve in more than 50% children in each group, and mean hearing threshold (38 dB and 35 dB) and proportion of children with greater than 25 dB hearing loss (98% and 88%) were not significantly different between the CIP and FGD groups. Side effects were rare. CONCLUSIONS: This study showed a similarly low rate of improvement or cure in children with persistent CSOM for both CIP and FGD topical therapies. Complications and side effects were insufficient to cease therapy or inform prescribing of either therapy.

Neamine inhibits xenografic human tumor growth and angiogenesis in athymic mice.

PURPOSE: We have previously shown that the aminoglycoside antibiotic neomycin blocks the nuclear translocation of angiogenin and inhibits its angiogenic activity. However, neomycin has not been considered as a favorable drug candidate for clinical development because of its known nephrotoxicity and ototoxicity. The aim of this study is to determine whether neamine, a nontoxic derivative of neomycin, possesses antitumor activity. EXPERIMENTAL DESIGN: The effect of neamine on the nuclear translocation of angiogenin was examined by means of immunofluorescence and Western blotting. The antitumor activity of neamine was determined with three different animal models. RESULTS: Neamine effectively blocked the nuclear translocation of angiogenin in endothelial cells and inhibited angiogenin-induced cell proliferation. It inhibited the establishment of human tumor xenografts in athymic mice in both ectopic and orthotopic tumor models. It also inhibited the progression of established human tumor transplants, whereas the structurally related antibiotic paromomycin had no effect. Immunohistochemical staining showed that both angiogenesis and cancer cell proliferation are inhibited by neamine. CONCLUSION: These results suggest that the nontoxic aminoglycoside antibiotic neamine is an effective inhibitor of nuclear translocation of angiogenin and may serve as an inhibitor for angiogenin-induced angiogenesis and cancer progression.

Prescription pattern for treatment of hemorrhoids under the universal coverage policy of Thailand.

The Universal Coverage Policy (UCP) or "30 Baht Scheme" was launched in Thailand in 2001. The policy caused a cutback in the budgets of all public hospitals and health service centers. Traditional medicine was then viewed as an alternative to save costs. This study examines whether this had any influence on hemorrhoid treatment prescription patterns, ratio of traditional/modern medicine, or the cost of hemorrhoid treatment after the UCP was implemented at a community hospital. The traditional medicine prescribed was Petch Sang Kart and the modern alternative was Proctosedyl. All hemorrhoid prescriptions at a community hospital from October 2000 to January 2003 were surveyed. Segmented Regression Analysis was applied to evaluate prescription trends, the ratios between the types of medicine, and the hemorrhoid treatment cost. A total of 256 prescriptions were analyzed. The average number of traditional medicine prescriptions per month were more than modern medicine (41 versus 16). During the study period, the trend of modern medicine use and the treatment cost was decreased (p < 0.01). The ratio of traditional/modern medicine increased 0.2 times (p = 0.02).

A blinded in-vitro study to compare the efficacy of five topical ear drops in clearing grommets blocked with thick middle ear effusion fluid.

OBJECTIVE: To compare the efficacy of 5% NaHCO3, 3% H2O2, Sofradex (dexamethasone sodium metasulphobenzoate 0.05%, framycetin sulphate 0.5%, gramicidin 0.005%), 0.33% acetic acid and 0.9% NaCl eardrops in clearing grommets blocked with harvested thick middle ear effusion fluid. STUDY DESIGN: A blinded in-vitro study. SETTING: District general hospital. PARTICIPANTS: A total of 473 grommets were blocked with freshly harvested unpooled thick middle ear effusion fluid obtained from 68 patients. MAIN OUTCOME MEASURES: Patency of the grommets before and 7 days after intervention was ascertained by tympanometry and close visual inspection. RESULTS: Instillation of eardrops leads to a statistically significant increase in the clearance of grommets as compared with not using any drops (chi2 = 14.3, d.f. = 5, P = 0.006). The numbers needed to treat were 2.8 for NaHCO3, 3.2 for 0.9% NaCl, 3.9 for 0.33% acetic Acid, 4.4 for Sofradex and 9.5 for H2O2 eardrops. Pair-wise comparison was only significant for comparison between 5% NaHCO3 and 3% H2O2 eardrops (Bonferroni corrected P = 0.01, odds ratio = 4.3, CI = 1.9-9.9). CONCLUSIONS: Use of eardrops leads to a clinically and statistically significant increase in the clearance of blocked grommets. Of the five drops used, 5% NaHCO3 was the most efficacious and 3% H2O2 the least efficacious. Limitations of this in-vitro study are recognized and a prospective in-vivo double blind randomized controlled trial is planned.

The use of perioperative Sofradex eardrops in preventing tympanostomy tube blockage: a prospective double-blinded randomized-controlled trial.

Around 11-12% of tympanostomy tubes are reported to become blocked by middle ear secretions or blood immediately following surgery, and so no longer function. Many otologists routinely instil an antibiotic and steroid-containing solution at the time of surgery in the belief that this may reduce this complication. The aim of the study was to investigate the efficacy of instilling the antibiotic and steroid-containing solution Sofradex at the time of grommet insertion in preventing grommet blockage. Double-blind randomized-controlled trial, comparing rates of grommet blockage in ears treated with Sofradex drops against control (no drops) in patients undergoing bilateral grommet insertion. Sixty-one pairs of results were obtained. There was a significant difference between the rates of grommet blockage in the two groups. Grommets with Sofradex drops instilled perioperatively were nine times less likely to be blocked than controls [1.6%versus 13.1%, odds ratio (Sofradex/control) = 9.06, 95% confidence interval (CI): 1.04-78.82, P = 0.05]. There was no association between grommet blockage and perioperative bleeding or the nature and presence of middle ear secretions. Sofradex eardrops are effective in reducing the rate of grommet blockage when instilled perioperatively.