Is antibiotic prophylaxis necessary in inguinal or femoral hernia repair for the prevention of surgical site infection in our environment?

Phase 1

Conditions: Inguinal or femoral hernia
Therapeutic area: Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]

Registration Number: CTIS2023-507319-36-00

Lead Sponsor: Hospital Universitario De Mostoles

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 518

Inclusion Criteria

Men or women over 18 years of age, Patients with inguinal, femoral or recurrent hernias., Willingness and ability to comply with scheduled visits, Signing of the informed consent

Exclusion Criteria

Allergy or intolerance to beta-lactams., Patients under 18 years of age., Laparoscopic surgery for hernia surgery, Unwillingness or inability to follow the procedures described in the protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To determine the percentage of patients with surgical site infection according to the type of fixation of the prosthetic material., Quantify the time elapsed until the development of the surgical site infection., To determine the percentage of patients who require drainage and/or antibiotic therapy in the presence of surgical site infection., Describe the most common pathogenic flora in surgical site infection, Analyze the costs in both analysis groups.;Primary end point(s): antibiotic prophylaxis in inguinal and femoral hernia repair;Main Objective: to demonstrate the non-inferiority of not giving antibiotic prophylaxis in inguinal and femoral hernia repair compared to its administration in the development of surgical site infection.

Secondary Outcome Measures