Clinical trial • Not applicable • Other
Cefazolin for Inguinal hernia | Femoral hernia
Not applicable trial of Cefazolin for Inguinal hernia | Femoral hernia.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Inguinal hernia | Femoral hernia
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 04-10-2023
- First CTIS Authorization Date
- 05-02-2024
Trial design
Antibiotic prophylaxis with cefazolin (CEFAZOLINA NORMON 1 g IV, authorized product) versus no antibiotic prophylaxis (no prophylaxis). Specific dosing schedule not detailed beyond product name/strength.-controlled Not applicable trial across 1 site in Spain.
- Comparator
- Antibiotic prophylaxis with cefazolin (CEFAZOLINA NORMON 1 g IV, authorized product) versus no antibiotic prophylaxis (no prophylaxis). Specific dosing schedule not detailed beyond product name/strength.
- Target Sample Size
- 518
Eligibility
Recruits 518 No vulnerable populations selected. Only adults (>18 years) are eligible. Informed consent is required ("Signing of the informed consent")..
- Vulnerable Population
- No vulnerable populations selected. Only adults (>18 years) are eligible. Informed consent is required ("Signing of the informed consent").
Inclusion criteria
- {"criterion_text":"- Men or women over 18 years of age\n- Patients with inguinal, femoral or recurrent hernias.\n- Willingness and ability to comply with scheduled visits\n- Signing of the informed consent"}
Exclusion criteria
- {"criterion_text":"- Allergy or intolerance to beta-lactams.\n- Patients under 18 years of age.\n- Laparoscopic surgery for hernia surgery\n- Unwillingness or inability to follow the procedures described in the protocol."}
Endpoints
Primary endpoints
- {"endpoint_text":"- antibiotic prophylaxis in inguinal and femoral hernia repair","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 518
- Recruitment Window Months
- 24
- Consent Approach
- Informed consent required: participants must sign the informed consent form ("Signing of the informed consent"). Only adults (>18) may consent; no assent process indicated. No details on languages or additional consent procedures provided.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 518
Spain
- Earliest CTIS Part Ii Submission Date
- 30-11-2023
- Latest Decision Or Authorization Date
- 05-02-2024
- Processing Time Days
- 67
- Number Of Sites
- 1
- Number Of Participants
- 518
Sites
- Site Name
- Hospital Universitario De Mostoles
- Department Name
- General and Digestive Surgery
- Principal Investigator Name
- Pablo Calvo Espino
- Principal Investigator Email
- pcalvoespino@gmail.com
- Contact Person Name
- Pablo Calvo Espino
- Contact Person Email
- pcalvoespino@gmail.com
Sponsor
Primary sponsor
- Full Name
- Hospital Universitario De Mostoles
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- CEFAZOLINA NORMON 1 g IV POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE EFG
- Active Substance
- Cefazolin
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Authorised (marketing authorisation number 64849 in Spain)
- Starting Dose
- 1 g
- Dose Levels
- 1 g
- Maximum Dose
- 2 g
Related trials
Other published trials that may interest you.