Preoperative Oral Antibiotics and Surgical Site Infections in Colon Surgery Without Mechanical Bowel Preparation. A Prospective, Multicentre, Single Blinded, Randomized Trial (ORALEV Study)

NCT02505581 Phase 4 COMPLETED

Routine antibiotics for the intravenous and oral prophylaxis of colorectal surgery will be used. Experimental group: Patients undergoing elective colorectal surgery that involves, colonic resection. The antibiotic prophylaxis in this group will be composed of: An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) and metronidazole (250mg / 8h, 3 doses) the day before surgery. \+ Control group: Patients undergoing elective colorectal surgery that involves, colonic resection. The antibiotic prophylaxis in this group will be composed of: An intravenous antibiotic pattern of cefuroxime 1g and metronidazole 1,5gr during anesthetic induction. In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time elongates more than three hours or there is an intraoperative bleeding over 1000cc. There won´t be a placebo treatment. Subject compliance will be evaluated according to the usual practice in surgical care field

Details

Lead sponsor	Hospital Universitari Vall d'Hebron Research Institute
Phase	Phase 4
Status	COMPLETED
Enrolment	536
Start date	2015-05
Completion	2018-11-10

Conditions

• Surgical Wound Infection

Interventions

• Extra dosage - cefuroxime (750mg) I.V
• Colorectal Surgery
• Ciprofloxacin 750 mg oral
• Metronidazole 250 mg oral
• Cefuroxime 1.5 g Intravenous
• Metronidazole 1 g Intravenous

Primary outcomes

• Wound infection — 30 days
  Superficial, deep, body-cavity This is a Clinical measure supported by image if necessary All the morbidity problems are reported independently

Countries

Spain