ABSTRACT
Nasal carriage of methicillin-resistant Staphylococcus aureus (MRSA) has been described as a risk factor for postsurgical infection. The purpose of this study is to determine the prevalence of MRSA in pediatric orthopaedic patients and whether being a MRSA carrier is a predictor of postoperative infection. Six hundred and ninety-nine consecutive pediatric patients who underwent MRSA nasal screening prior to surgery were studied. Postoperative cultures, total surgical site infections (SSIs), and epidemiological and surgical prophylaxis data were reviewed. Forty-four of 699 patients (6.29%) screened positive for MRSA. Nine of the 44 patients (20.5%) that screened positive for MRSA had a subsequent SSI compared to 10 of the 655 patients (1.52%) that screened negative (p < 0.05). All 9 patients with a SSI had myelomeningocele. The prevalence of MRSA was 6.30% and was predictive of postoperative infection. Children with myelomeningocele were at the highest risk for having a positive MRSA screening and developing SSI.
ABSTRACT
PURPOSE: To investigate whether the widely accepted advantages as sociated with the use of chitosan as a nasal drug delivery system might be further improved by application of chitosan formulated a nanoparticles. METHODS: Insulin-chitosan nanoparticles were prepared by the ionotropic gelation of chitosan glutamate and tripolyphosphate pentasodium and by simple complexation of insulin and chitosan. The nasal absorption of insulin after administration in chitosan nanoparticle formulations and in chitosan solution and powder formulations wa evaluated in anaesthetised rats and/or in conscious sheep. RESULTS: Insulin-chitosan nanoparticle formulations produced a pharmacological response in the two animal models, although in both cases the response in terms of lowering the blood glucose levels was less (to 52.9 or 59.7% of basal level in the rat, 72.6% in the sheep than that of the nasal insulin chitosan solution formulation (40.1% in the rat, 53.0% in the sheep). The insulin-chitosan solution formulation was found to be significantly more effective than the complex and nanoparticle formulations. The hypoglycaemic response of the rat to the administration of post-loaded insulin-chitosan nanopar ticles and insulin-loaded chitosan nanoparticles was comparable. As shown in the sheep model, the most effective chitosan formulation for nasal insulin absorption was a chitosan powder delivery system with a bioavailability of 17.0% as compared to 1.3% and 3.6% for the chitosan nanoparticles and chitosan solution formulations, respectively. CONCLUSION: It was shown conclusively that chitosan nanoparticles did not improve the absorption enhancing effect of chitosan in solution or powder form and that chitosan powder was the most effective for mulation for nasal delivery of insulin in the sheep model.
Subject(s)
Chitin/analogs & derivatives , Chitin/administration & dosage , Drug Delivery Systems/methods , Insulin/administration & dosage , Nanotechnology/methods , Administration, Intranasal , Animals , Chemistry, Pharmaceutical , Chitin/chemistry , Chitin/pharmacokinetics , Chitosan , Female , Humans , Insulin/chemistry , Insulin/pharmacokinetics , Male , Models, Animal , Pharmaceutical Solutions/administration & dosage , Pharmaceutical Solutions/chemistry , Pharmaceutical Solutions/pharmacokinetics , Powders , Rats , Rats, Wistar , SheepABSTRACT
Well-designed data management processes are essential in ensuring the quality of data collected in multicenter clinical trials. This paper describes the data management processes and systems that were developed by the data coordinating center of the Asthma Clinical Research Network. A combination of manual and electronic processes has been designed to process clinical trial data from the point of collection to statistical analysis. A distributed database management system consisting of modular applications for separate data processing activities was developed to enter, track, verify, validate, and edit collected data. In addition, processes for monitoring and reporting data quality are discussed.
Subject(s)
Asthma , Clinical Trials as Topic/methods , Databases, Factual , Data Collection , Female , Humans , ResearchABSTRACT
Quality control and assurance are very important issues for multicenter clinical investigation. Although such investigation usually states that those factors are part of the investigation, at best this occurs to a minimal extent. Indeed, to ensure the best possible investigatory results with the least amount of variance between centers, the Asthma Clinical Research Network (ACRN) instituted strict written criteria that were continually overviewed. This article describes the ACRN's quality control of: clinic procedures and equipment, training and certification of study personnel, site visit evaluations, and the procedures of bronchoscopy and sputum induction. The examples given in this report demonstrate how various aspects of our investigation are performed.
Subject(s)
Asthma , Clinical Trials as Topic/methods , Multicenter Studies as Topic , Patient Care Team , Quality Assurance, Health Care , Bronchoscopy/methods , Certification , HumansABSTRACT
Traditional methods of performing refractions depend on a trained refractionist being present with the subject and conducting an interactive form of subjective testing. A fully automated refraction system was installed in 13 optical dispensaries and after 15 months the patient and statistical information was gathered. The data from all operators were consistent and suggested a lack of operator effect on the refraction results. The mean of the SD of subjective sphere measurements was 0.2, or slightly less than a quarter dioptre, which would be an acceptable level of accuracy for ordering corrective lenses. The present study suggests an absence of operator influence on the results of the refractions and a degree of consistency and accuracy compatible with the prescription of lenses.
