Parenteral Antibiotics Compared to Combination of Oral and Parenteral Antibiotics in Colorectal Surgery Prophylaxis

PHASE4CompletedINTERVENTIONAL
Enrollment

536

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

April 30, 2017

Study Completion Date

November 10, 2018

Conditions
Surgical Wound Infection
Interventions
DRUG

Extra dosage - cefuroxime (750mg) I.V

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

PROCEDURE

Colorectal Surgery

Both groups undergo colorectal surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria)

DRUG

Ciprofloxacin 750 mg oral

An oral antibiotic pattern of ciprofloxacin (750 mg / 12h, 2 doses) the day before surgery.

DRUG

Metronidazole 250 mg oral

An oral antibiotic pattern of metronidazole (250 / 8h, 3 doses) the day before surgery.

DRUG

Cefuroxime 1.5 g Intravenous

An intravenous antibiotic pattern of cefuroxime 1.5 g during anesthetic induction.

DRUG

Metronidazole 1 g Intravenous

An intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction.

Trial Locations (3)

17007

Hospital Universitari de Girona Dr. Josep Trueta, Girona

Unknown

Hospital de Bellvitge, L'Hospitalet de Llobregat

08035

Hospital General Universitario Vall d´Hebron, Barcelona

All Listed Sponsors
lead

Hospital Universitari Vall d'Hebron Research Institute

OTHER

NCT02505581 - Parenteral Antibiotics Compared to Combination of Oral and Parenteral Antibiotics in Colorectal Surgery Prophylaxis | Biotech Hunter | Biotech Hunter