Use of mometasone furoate to prevent polyp relapse after endoscopic sinus surgery.

OBJECTIVE: To evaluate the effect of mometasone furoate on prevention or reduction of nasal polyp relapse and worsening of symptoms after functional endoscopic sinus surgery (FESS). DESIGN: Randomized, double-blind, placebo-controlled, multicenter study. SETTING: Ten ear, nose, and throat clinics in Sweden. PATIENTS: Adult subjects with bilateral nasal polyps fulfilling the criteria for surgery who underwent FESS. INTERVENTIONS: Two weeks after FESS, subjects were randomized to receive mometasone furoate nasal spray, 200 microg once daily, or placebo. MAIN OUTCOME MEASURES: Time to relapse, defined as an increase of 1 point or more on a 0- to 6-point endoscopic polyp scale. RESULTS: In the per-protocol population (n = 104), median time to relapse was 173 and 61 days for the mometasone and placebo groups, respectively (P = .007; hazard ratio [95% confidence interval], 0.72 [0.55-0.93]). In the intent-to-treat population (n = 159), median time to relapse was greater than 175 days in the mometasone group and 125 days in the placebo group (P = .049; hazard ratio, 0.79 [0.62-0.99]). The most common adverse event was epistaxis, with 6 cases reported in the mometasone group and 3 in the placebo group. CONCLUSIONS: Postoperative use of mometasone furoate, 200 microg once daily, provided a statistically significant longer time to relapse of nasal polyps than did placebo in subjects with bilateral nasal polyposis who had undergone FESS. The ability of mometasone to prevent or prolong the time to relapse among subjects undergoing FESS is important because this may prolong the time to subsequent surgery. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00731185.

Tracheostomy inner cannula care: a randomized crossover study of two decontamination procedures.

BACKGROUND: Today several methods for decontaminating inner cannulae exist. These methods are not based on scientific data, but often on local clinical tradition. This study compares two different decontamination methods. The aim was to find a practical and safe decontamination method. It is a randomized, single-blinded, comparative crossover study. METHODS: Fifty outpatients with long-term tracheostomy with an inner cannula were consecutively included and randomly allocated to begin with one of two different treatment sequences: detergent and chlorhexidine-alcohol (A) or detergent (B). Samples for bacterial culture were taken before and after decontamination, and the number of bacteria colonies was counted. RESULTS: Before decontamination, the inner cannulae grew high numbers of bacteria, which were parts of the normal flora of the upper respiratory tract and did not differ significantly between the two sequences (AB; BA). The primary variable was the culture count value after chlorhexidine-alcohol/detergent (A) and detergent (B). The effects of both methods were larger than expected, and the results showed a nearly total elimination of organisms. The equivalence criterion, ratio of mean colony counts (A/B) >0.8, was met at a significance level of P<0.001. CONCLUSIONS: Cleaning the tracheostomy inner cannula with detergent and water is sufficient to achieve decontamination.

Therapeutic efficacy by recombinant human granulocyte/monocyte-colony stimulating factor on mucositis occurring in patients with oral and oropharynx tumors treated with curative radiotherapy: a multicenter open randomized phase III study.

BACKGROUND: Previous studies suggested granulocyte-macrophage-colony stimulating factor (GM-CSF) might be beneficial for radiotherapy-induced mucositis. This trial examined the efficacy of GM-CSF in reducing mucositis of the oral cavity and/or oropharynx compared with conventional treatment. METHODS: Mucositis, documented by a five-grade scale, was defined in patients with tumors of the head-neck. Centers were allowed to use their own preferred fractionation regimen. Randomization to treatment was decided before radiotherapy. Treatment with GM-CSF 4 microg/kg/d subcutaneous, started when patients displayed a mucositis score > or = 1.5. RESULTS: Ninety-two patients entered the study according to intention-to-treat principle. Twenty did not reach a mucositis index of 1.5. Sixty-one patients were included in the statistical analysis. Forty-five percent of the patients randomized to receive GM-CSF had a significant reduction of the mucositis more than one grade compared to 9% of the conventional treated. CONCLUSIONS: In severe mucositis, GM-CSF is more effective than conventional treatment.