OBJECTIVE: To evaluate the ability of a novel topical antimicrobial gel containing cetrimide, bacitracin, and polymyxin B sulfate to prevent infections of minor wounds. DESIGN: A clinical trial compared the test preparation with placebo and a povidone iodine antiseptic cream. SETTING:Five primary schools in Sydney, Australia, participated in the study over a 6-week spring/summer school term. SUBJECTS:Children aged 5-12 years with parental consent were eligible for study participation. Accidental injuries occurring at school were treated in a standardized manner by nurses at each site. OUTCOME MEASURES: Wounds were evaluated by the medical practitioner after 3 days of topical treatment. The clinical outcome was classified as resolution or suspected infection. If a clinical infection was suspected, the injury was swabbed for microbiologic evaluation. Growth of a dominant microorganism was classified as a microbiologic infection. RESULTS: Of the 177 injuries treated, there were nine clinical infections. A comparison of these showed a significant difference among treatment groups (p < 0.05). This difference was associated with the test preparation and placebo; the test preparation reduced the incidence of clinical infection from 12.5% to 1.6% (p < 0.05; 95% CI, 0.011 to 0.207). A comparison of microbiologic infections showed no significant differences among treatment groups (p > 0.05). CONCLUSIONS: The novel gel preparation containing cetrimide, bacitracin, and polymyxin B sulfate showed therapeutic action and reduced the incidence of clinical infections in minor accidental wounds. It may be a suitable product for first aid prophylaxis.
RCT Entities:
OBJECTIVE: To evaluate the ability of a novel topical antimicrobial gel containing cetrimide, bacitracin, and polymyxin B sulfate to prevent infections of minor wounds. DESIGN: A clinical trial compared the test preparation with placebo and a povidone iodine antiseptic cream. SETTING: Five primary schools in Sydney, Australia, participated in the study over a 6-week spring/summer school term. SUBJECTS:Children aged 5-12 years with parental consent were eligible for study participation. Accidental injuries occurring at school were treated in a standardized manner by nurses at each site. OUTCOME MEASURES: Wounds were evaluated by the medical practitioner after 3 days of topical treatment. The clinical outcome was classified as resolution or suspected infection. If a clinical infection was suspected, the injury was swabbed for microbiologic evaluation. Growth of a dominant microorganism was classified as a microbiologic infection. RESULTS: Of the 177 injuries treated, there were nine clinical infections. A comparison of these showed a significant difference among treatment groups (p < 0.05). This difference was associated with the test preparation and placebo; the test preparation reduced the incidence of clinical infection from 12.5% to 1.6% (p < 0.05; 95% CI, 0.011 to 0.207). A comparison of microbiologic infections showed no significant differences among treatment groups (p > 0.05). CONCLUSIONS: The novel gel preparation containing cetrimide, bacitracin, and polymyxin B sulfate showed therapeutic action and reduced the incidence of clinical infections in minor accidental wounds. It may be a suitable product for first aid prophylaxis.
Authors: P F Builders; B Kabele-Toge; M Builders; B A Chindo; Patricia A Anwunobi; Yetunde C Isimi Journal: Indian J Pharm Sci Date: 2013-01 Impact factor: 0.975