Prophylaxis of surgical wound infection with topical antibiotics

Phase 1

• Conditions: Surgical wound infection; MedDRA version: 20.0Level: PTClassification code 10048038Term: Wound infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2017-002669-23-ES
• Lead Sponsor: Hospital General Universitari de Granollers

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-01
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

• Patients older than 18 years.
• Patients who require urgent surgical intervention and come from the emergency department.
• Patients undergoing open abdominal surgery.
• Elective or urgent cesarean.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 448
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 112

Exclusion Criteria

• Patients with primary peritonitis and hepatic cirrhosis.
• Patients allergic to the antibiotic used in the study.
• Patients who have undergone a recently opened surgical procedure (up to 30 days pre-intervention), a prosthesis placement of synthetic material (mesh) or those who can not close the surgical wound according to the surgeon's criteria.
• ASA-5 patients

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the effect of topical antibiotic prophylaxis on the incidence of surgical site infection in abdominal surgery;Secondary Objective: Effect of the topical prophylaxis protocol on the reduction of hospital stay, bacterial load and resistance patterns of surgical wound infection in patients submitted to urgent dirty or contaminated surgery.;Primary end point(s): Presence of surgical infection within 30 days after the surgery.;Timepoint(s) of evaluation of this end point: 30 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Reduction of costs associated with surgical infections;Timepoint(s) of evaluation of this end point: Annual