Overview
Sponsor-declared trial summary
Inguinal or femoral hernia
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.
Key facts
- Sponsor
- Hospital Universitario De Mostoles
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Decision date (initial)
- 2024-02-05
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
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 objectives 5
- 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.
Conditions and MedDRA coding
Inguinal or femoral hernia
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 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 4
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- antibiotic prophylaxis in inguinal and femoral hernia repair
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Cefazolina Normon 1 G IV Polvo Y Disolvente Para Solucion Inyectable Efg
PRD370703 · Product
- Active substance
- Cefazolin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01DB04 — -
- Marketing authorisation
- 64849
- MA holder
- LABORATORIOS NORMON, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital Universitario De Mostoles
- Sponsor organisation
- Hospital Universitario De Mostoles
- Address
- Calle Rio Jucar Sn
- City
- Mostoles
- Postcode
- 28935
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Universitario De Mostoles
- Contact name
- Secretaría de Cirugía sexta planta
Public contact point
- Organisation
- Hospital Universitario De Mostoles
- Contact name
- Secretaría de Cirugía sexta planta
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 518 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-04 | Spain | Acceptable 2024-01-29
|
2024-02-05 |