Prophylaxis of surgical wound infection with topical antibiotics

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002669-23-ES

Enrollment

560

Registered

2017-12-01

Start date

2017-12-21

Completion date

Unknown

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical wound infection MedDRA version: 20.0 Level: PT Classification code 10048038 Term: Wound infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Amoxicilina/Acido Clavulánico SANDOZ Product Name: Amoxicilina/Acido Clavulánico SANDOZ Pharmaceutical Form: Powder for infusion INN or Proposed INN: AMOXICILLIN CAS Number: 26787-78-0 Con

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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

Countries

Spain

Contacts

Public ContactDiana Navarro

Hospital General Universitari de Granollers

recerca@fhag.es34938425000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026