A research article study will be conducted to describe the effects of antibiotic administration to pre-operative patients at different time frames. The study will be conducted in order to identify the effectiveness of this regimen in reducing infections caused by surgery as well as reducing deaths by investigating mortality prevention from each type of surgery through the preventive use of antibiotics. The prospective study will be conducted for 15 years. The study will commence on January 1 of a specified year and will list all patients that are admitted for surgery at the hospital.
The patients were will classified according to age, gender, type of surgery, ethnicity and other medical disorders that are presently reported at the time of admission for surgery. The length of stay of each patient will also be taken note of. The type, dosage and duration of antibiotic administration prior to surgery will be documented and the patients will be given follow-up consultations with their surgery for the next 2 months. Any type of microbial infection that ensues before, during and after surgery will be noted for each surgery patient.
A control group will also be identified based on a case- and age-matched classification. In order to determine the effectiveness of pre-operative antibiotic administration to surgery patients, post-operative assessment will be performed. In addition, the patient records will also be consulted for any reports on side-effects and microbial infection during the recovery period. A two-tailed t-test will be performed to detect any associations between a specific treatment and a particular incidence of infection.
Any significant variations in relation to the results of the study will then be detected from the statistical analyses performed. Any ethical considerations in this clinical will be included in order to systematically perform the study. The ethical issues that will be reviewed in this study will include the size of the study population, wherein there will be an established minimum subject size in order to deem the clinical trial to be valid. In addition, a smaller feasibility study or interim analysis will first be conducted before a full-blown clinical will be commenced (Simon et al.
, 1985). The interim analysis will provide the researcher will ample testing ground to determine whether the proposed clinical study will be practical enough to complete and the results that may be generated will be reliable enough for application to the clinical setting. Any previous published clinical reports will also be researched in order to determine that there are sporadic reports that describe the similar aim of this clinical trial (Hart et al. , 2008; White et al. , 2008).
For the interim analysis, approximately 50 patients that are scheduled for surgery will be asked to participate in the study. This sample population will allow identification of potential problems that may be encountered during the clinical trial. In addition, the prospective study will be conducted in different health centers, in order to collect as many participants as possible and to eradicate any bias in the assessment of the study (Albrecht et al. , 2000). The multi-center approach also prevents any substandard inclusion selection of subjects that will be admitted to the clinical trial.
The inclusion criteria of the clinical trial will also be rigorously assessed in order to prevent any confusion and misdiagnosis for the treatment of antibiotics prior to the surgical procedure. The clinical trials that will be conducted in the participating centers will be briefed with regards to the procedures to be followed with regards to the assessment of the patient as well as the administration of antibiotics prior to surgery and the consultation after the operation.
Such rules and guidelines for the clinical trial will be strictly followed in order to have a common protocol for all the participating centers for this clinical trial. The evaluation of data collected and the analytical approaches will also be standardized for all centers involved in the clinical trial. References Albrecht, W. , Horenblas, S. & Marechal, J. M. (2000). Randomized phase II trial assessing estramustine and vinblastine combination chemotherapy vs estramustine alone in patients with hormone escaped progressive metastatic prostate cancer. Journal of Urology, 161, 298-304.
Hart, P. A. , Bechtold, M. L. , Marshall, J. B. , Choudhary, A. , Puli, S. R. & Roy, P. K. (2008). Prophylactic antibiotics in necrotizing pancreatitis: A meta-analysis. South Medical Journal, 101,1126-1131. Simon, R. , Wittes, R. E. & Ellenberg, S. S. (1985). Randomized phase II clinical trials. Cancer Treatment Reports, 69,1375-1381. White, R. R. , Pitzer, K. D. , Fader, R. C. , Rajab, M. H. & Song, J. (2008). Pharmacokinetics of topical and intravenous cefazolin in patients with clean surgical wounds. Plastic and Reconstructive Surgery, 122,1773-1779.