drugset / Trial / NCT01524081

Antibiotic Prophylaxis in the Prevention of Surgical Site Infections After Selected Urgent Abdominal Surgical Procedures

NCT01524081

Phase 3 Completed 187 enrolled The Faculty Hospital Na Bulovce
RandomizedParallel-groupDouble-blindPrevention

Summary

Aim of prospective randomized a placebo controlled study is to prove that in case of acute surgical procedure due to appendicitis, ileus of small bowel and perforation of small bowel and stomach appropriately administered antibiotic prophylaxis is effective with lower incidence of infection in surgical site and comparable risk of development of other nosocomial infections versus group without antibiotic prophylaxis. Secondary aim is to determine risk of developing nosocomial infection in the above mentioned group of patients, identify group of patients which does not benefit from prophylaxis, and compile financial costs for antibiotic prophylaxis and treatment of nosocomial infections and thus the background for the recommended procedure with regards that such prospective study does not exist in the Czech Republic.

Timeline

Start
2008-07
Primary completion
2011-07
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified Intravenous
Subject Cefuroxime Small molecule 1.5 g Intravenous
Subject Fluconazole Small molecule 800 mg Intravenous
Subject Metronidazole Small molecule 1 g Intravenous
Subject clavulanic acid Small molecule Intravenous