Intravenous Versus Combined Oral and Intravenous Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Elective Colorectal Surgery

• Status: Completed
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

To assess the effects of a combined antimicrobial prophylaxis using oral ornidazole (the day before surgery) and intravenous cephalosporin (before surgical incision) with that of intravenous cephalosporin alone (standard of care) in combination with oral placebo on the incidence of SSI within 30 days after elective colorectal surgery.

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

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Treatments: Anti-Infective Agents; Ornidazole

Criteria

Inclusion Criteria:

• Age > 18

• Laparoscopic or non-laparoscopic elective colorectal surgery

Exclusion Criteria:

• Non elective colorectal surgery (emergent surgery and/or reintervention or revision of a previous colorectal procedure)

• Significant concomitant surgical procedure (e.g., liver resection for metastasis)

• Bacterial infection at the time of surgery or antimicrobial therapy up to 2 weeks before surgery

• Inflammatory bowel disease

• Severe obesity (defined as a BMI >35 kg/m2)

• Known history of hypersensitivity to β-lactams and imidazoles

• Preoperative severe impairment in renal function (creatinine clearance (MDRD) < 30 ml/min)

• Patients with known colonization with multidrug-resistant digestive bacteria, especially multidrug-resistant gram-negative bacteria (requiring specific infection control measures)

• Allergy to lactose, galactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption (rare metabolic disease)

• Pregnant women, breastfeeding women, women of childbearing age without effective contraceptive- Refusal to participate or inability to provide informed consent