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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Faculty Hospital Na Bulovce
• Treatments: Amoxicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Cefuroxime; Cefuroxime axetil; Clavulanic Acid; Clavulanic Acids; Fluconazole; Metronidazole; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• patient older > 18 years

• Patient indicated for emergent surgery for:

acute appendicitis / perforated gastric or duodenal ulcer / small bowel obstruction

• The patient can understand the aim of the study and sign informed consent (including language barriers)

• The diagnose is confirmed intraoperatively

Exclusion Criteria:

• Refused the participation in the study and

• uninsured self-payers

• Patients with known allergy to the substance administered during the study or chronic medication contraindicated with study drug

• Pregnant or breastfeeding women

• Use of antibiotics in the last 2 weeks

• Known serious illness (heart failure, renal failure, liver failure, CNS disorders)

• Signs of infectious mononucleosis and risk of infectious endocarditis