About this trial
This research is studying a drug called cefoxitin already approved by the Food and Drug Administration (FDA) to reduce the risk of infection after surgery to remove an appendix. Researchers are studying a large group of people to continue to learn how best to dose antibiotics. This research will compare the current standard treatment which is a single dose prior to surgery to a new method that includes adding another dose of cefoxitin within 30 minutes of starting the surgery. This study will measure cefoxitin concentrations in blood, fat, and appendix tissue samples to compare the standard dosing method to our new method. This information will help us figure out the right dose of this drug to prevent infection after surgery to remove an appendix.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of acute appendicitis and plan to undergo appendectomy at the University of Michigan
Disqualifiers
Prisoners
Patients that are pregnant
Patients with perforation or abscess on CT Scan
Trial design
Parallel
Treatments tested in this trial
Cefoxitin
DrugCefoxitin 2000 mg Bolus Injection
Treatment groups
Trial outcomes
Primary outcomes
Probability of Achieving Optimal Antibiotic Concentration in Appendix Tissue
The probability of achieving 50% time above 8 mcg/mL (cefuroxime or cefoxitin) in appendix tissue in the intervention compared to the non-intervention (standard of care) arm.
Sponsors and contacts
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University of Michigan
Lead sponsor
Agency for Healthcare Research and Quality (AHRQ)
Collaborator