ERYTHROMYCIN for Surgical site infection

Inclusion criteria

• {"criterion_text":"- Adult patients (aged ≥ 18 years) scheduled for elective laparoscopic, open and/or robotic assisted colon or rectal surgery for benign or malignant disease"}

Exclusion criteria

• {"criterion_text":"- 1) inability to provide informed consent"}
• {"criterion_text":"- (2) acute surgery for bleeding, perforation or obstruction"}
• {"criterion_text":"- (3) uncontrolled diabetes mellitus"}
• {"criterion_text":"- (4) preoperative steroid use"}
• {"criterion_text":"- (5) antibiotic use within 2 weeks of proposed elective surgery date"}
• {"criterion_text":"- and (6) previous allergic reaction to the antibiotics utilised in this study."}
• {"criterion_text":"- (7) Patients with contraindications to neomycin and erythromycin."}
• {"criterion_text":"- (8) Patients with renal and hepatic impairment."}
• {"criterion_text":"- (9) Patients who have a positive pregnancy test."}
• {"criterion_text":"- (10) Patients requiring more extensive antibiotic prophylaxis."}

Primary endpoints

• {"endpoint_text":"- Incidence of surgical site infection","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Infectious complications other than surgical site infections","definition_or_measurement_approach":""}
• {"endpoint_text":"- length of hospital stay","definition_or_measurement_approach":""}
• {"endpoint_text":"- postoperative complications as per Clavien Dindo Classification","definition_or_measurement_approach":""}
• {"endpoint_text":"- anastomotic leakage","definition_or_measurement_approach":""}
• {"endpoint_text":"- mortality","definition_or_measurement_approach":""}

Ireland

Earliest CTIS Part Ii Submission Date

19-01-2025

Latest Decision Or Authorization Date

07-05-2025

Processing Time Days

108

Number Of Sites

1

Number Of Participants

322

Primary sponsor

Full Name

University Hospital Limerick

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Ireland