Evaluation of a bioadhesive device for the management of aphthous ulcers.

BACKGROUND: Aphthous ulcers are common and painful. Current treatments are palliative and focused on pain reduction. This article reports on the clinical trials of a novel, bioadhesive treatment modality. METHODS: Formulations of 2-octyl cyanoacrylate, or 2-OCA, tissue adhesive were tested in two blinded, sham-controlled studies. A total of 200 patients with a single, painful aphthous ulcer were entered. In the first study, the investigators applied the tissue adhesive to the aphthous ulcers; in the second trial, the subjects themselves applied the tissue adhesive to their ulcers. The authors evaluated the safety, pain reduction and healing times associated with the bioadhesive. RESULTS: The bioadhesives were found to be safe with no significant adverse events. The short- and long-term pain reduction achieved with an investigator-applied adhesive was significant compared with that achieved with a sham device (P = .024 and P = .036, respectively). The investigator-applied adhesive also demonstrated a significant reduction in healing time over the sham device (P = .021). In the definitive trial, in which the subjects themselves applied the tissue adhesive, pain reduction with a predicate device approved by the U.S. Food and Drug Administration and with the bioadhesive was significantly better than with a sham application (P < .05). The active devices were not statistically different from each other (P = .37). No difference in healing time was evident between devices and the sham. CONCLUSIONS: The formulations of 2-OCA tissue adhesives tested were safe and demonstrated statistically significant pain reduction when applied by either the investigators or the subjects. CLINICAL IMPLICATIONS: Our clinical trials indicate that these novel tissue adhesives could be used as nonprescription, over-the-counter devices to provide significant pain relief for patients suffering from aphthous ulcers.

Intestinal effects of sulfate in drinking water on normal human subjects.

Uncontrolled observations implicate sulfate in drinking water at concentrations exceeding 500-700 mg/liter as a cause of diarrhea, but controlled studies have not been reported. We conducted a controlled study in normal adults to determine the effect of various drinking water sodium sulfate concentrations on bowel function. Ten healthy subjects were given a constant diet and fluid intake. Fluid consisted of 36 ml/kg/day of drinking water of various known sulfate concentrations and 500 ml of other fluid. In a dose-ranging study, four subjects received drinking water with sulfate concentrations of 0, 400, 600, 800, 1000, and 1200 mg/liters for six consecutive two-day periods. In a single-dose study, six other subjects received water with sulfate concentrations of 0 and 1200 mg/liter for two consecutive six-day periods. Stool mass, frequency, and consistency and mouth-to-anus appearance time of colored markers were measured. In the dose-ranging study, the only significant linear trend was decreasing mouth-to-anus appearance time with increasing sulfate concentrations. In the single-dose study, 1200 mg/liter sulfate caused a significant but clinically mild increase in mean stool mass per six-day pool from 621 g to 922 g (P = 0.03). When all 10 subjects were used to compare effects of 0 mg/liter and 1200 mg/liter sulfate, significant differences in stool consistency (P = 0.02) and transit time (P = 0.03) were observed. None of the subjects reported diarrhea or passed more than three stools per day. In 10 normal adult subjects, sulfate in drinking water at a concentration of 1200 mg/liter, which is higher than reported to occur in US municipal water sources, caused a measurable but clinically insignificant increase in stool mass and decrease in stool consistency and appearance time, but no change in stool frequency and no complaint of diarrhea.

Infection risk factors in febrile, neutropenic children and adolescents.

We studied 276 fever episodes with an absolute neutrophil count (ANC) < 500/mm3 to determine patient characteristics predicting serious infection. Infections occurred in 38% of patients. Blood cultures were positive in 58% of documented infections. There was no difference in the rates of infection or positive blood culture when ANC was < 200/mm3 compared with a higher ANC. However, certain high risk infections were more common with an ANC < 200/ mm3. Leukemia patients had more infections compared with other groups. Serious infections were more common during induction therapy or relapse. Infection incidence varied significantly with patient age and onset of fever in the inpatients. Less than one fifth of febrile neutropenic episodes had no risk features for serious infection. We conclude that several clinical characteristics correlate with serious infection in febrile, neutropenic children and adolescents receiving modern supportive care. Despite improvements in supportive care measures, most febrile, neutropenic patients need close observation and empiric intravenous antibiotic therapy.