A study will be conducted that will investigate the effects of antibiotic administration to pre-operative surgical patients. The clinical study will be performed using a prospective approach, wherein all future surgical patients that will be admitted to the hospital starting on a defined date will be included in the study. The main inclusion criterion for the study population is the surgical procedure that will be performed on each patient.
Pertinent information will be collected from each subject, including age, gender, type of surgery and any other co-morbidities that have been clinically diagnosed. The details of the administration of the antibiotic including type of antibiotic, dosage, time frame and duration will be recorded. The study will be conducted for 15 years and will be participated in by a number of centers around the country. Standard guidelines for inclusion, treatment and analysis of cases will be implemented in order to prevent any selection and treatment bias among the study participants.
Case-, age- and sex-matched controls will also be included in the clinical trial. Proper informed consent will be collected from each study participant. In order to analyze the data that has been collected, a two-tailed t-test will be employed to screen for associations between a particular antibiotic regimen and a specific type of microbial incident that a study participant experienced (Parvizi et al. , 2008). Variations that are correlated with the resulting data will also be reviewed in the investigation.
Ethical issues that will be considered include the voluntary participation of each subject in the investigation (Jefford and Moore, 2008). The study participants will also be protected in the clinical investigation by keeping their identities confidential and their cases will only be identified as numerical marks in the database (Park and Grayson, 2008). The clinical trial will also keep the dosage of the antibiotic and the duration of treatment confidential in order for the study participant to be blind or unprejudiced during the clinical trial.
I fully understand the aims and the procedures of the clinical trial, of which are as follows: 1. Information with regards to my surgical procedure and the associated medical disorder will be collected. 2. Personal information such as name, age, gender and other medical disorders that co-exist with my current surgical procedure will be collected. 3. A specific type and dosage of antibiotic will be administered to me prior to my surgery.
The clinical investigators will check whether any type of infection occurs soon after the surgical procedure. A post-operative consultation will also be scheduled in order to determine my condition after 2 weeks. 5. I am free to withdraw from the study at any time. 6. I am aware that there will be no immediate benefits from participating in this study but the information that may be generated from this investigation will be useful in future treatment regimens.
References
Jefford, M. & Moore R. (2008). Improvement of informed consent and the quality of consent documents. Lancet Oncology, 9,485-493. Park, S. S. & Grayson, M. H. (2008). Clinical research: Protection of the “vulnerable”? Journal of Allergy and Clinical Immunology, 121,1103-1107. Parvizi, J. , Chakravarty, R. , Og, B. & Rodriguez-Paez, A. (2008). Informed consent: Is it always necessary? Injury, 39,651-655.