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Study on the Necessity of Cefazolin in Preventing Infections After Inguinal or Femoral Hernia Surgery

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on understanding the necessity of using antibiotics during surgery for patients with an inguinal or femoral hernia. An inguinal hernia occurs when tissue pushes through a weak spot in the groin area, while a femoral hernia is a similar condition but occurs lower in the groin. The study will explore whether giving antibiotics, specifically cefazolin, is essential to prevent infections at the site of surgery. Cefazolin is a type of antibiotic that is often used to prevent infections during surgical procedures.

The purpose of the study is to determine if not using antibiotics is just as effective as using them in preventing infections after hernia repair surgery. Participants in the study will either receive the antibiotic cefazolin or a placebo during their surgery. The study will monitor the development of any surgical site infections in both groups to compare the outcomes.

Throughout the study, participants will undergo their scheduled hernia repair surgery and will be observed for any signs of infection at the surgical site. The study aims to provide valuable information on whether antibiotics are necessary for all patients undergoing this type of surgery, potentially leading to changes in standard medical practices. The trial is expected to continue until the end of 2025.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. Participants must be men or women over 18 years of age with inguinal, femoral, or recurrent hernias. Participants must be willing and able to comply with scheduled visits and sign the informed consent.

  2. Step 2

    Pre-surgery preparation

    Participants are prepared for inguinal or femoral hernia repair surgery. This includes standard pre-surgery procedures and assessments.

  3. Step 3

    Surgery and treatment

    During the surgery, participants may receive antibiotic prophylaxis with cefazolin to prevent surgical site infection. Cefazolin is administered intravenously as a solution for injection. The decision to administer cefazolin is based on the study's objective to compare outcomes with and without antibiotic prophylaxis.

  4. Step 4

    Post-surgery monitoring

    After surgery, participants are monitored for the development of surgical site infections. This monitoring is part of the study's primary endpoint to assess the necessity of antibiotic prophylaxis in hernia repair.

  5. Step 5

    Follow-up visits

    Participants attend scheduled follow-up visits to evaluate recovery and any potential infections. These visits are crucial for collecting data on the effectiveness of the treatment approach.

  6. Step 6

    Completion of study participation

    Participation in the study concludes by the estimated end date of December 31, 2025. Participants' data contribute to the study's objective of determining the necessity of antibiotic prophylaxis in hernia repair.

Who can join the trial?

5 criteria

  • Men or women over 18 years of age
  • Patients with **inguinal** or **femoral hernias**. These are types of hernias that occur in the groin area.
  • Patients with **recurrent hernias**, which means the hernia has come back after previous treatment.
  • Willingness and ability to attend scheduled visits
  • Signing of the **informed consent**, which is a document that explains the study and confirms your agreement to participate.

Who cannot join the trial?

3 criteria

  • Patients with an inguinal or femoral hernia cannot participate. These are types of hernias that occur in the groin area.
  • Individuals who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Participants who are part of a vulnerable population are not eligible. This means people who might need special protection or care.
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Investigated drugs

Antibiotic Prophylaxis is a treatment involving the use of antibiotics to prevent infections. In this clinical trial, it is used to see if giving antibiotics before surgery can help prevent infections at the site of the surgery for patients undergoing inguinal or femoral hernia repair. The trial aims to determine if not using antibiotics is just as effective as using them in preventing these infections.

What is already known about the treatment

Antibiotic Prophylaxis – This medication is typically administered orally or intravenously, depending on the specific antibiotic used, and is applied before surgical procedures to prevent infections. In the context of the clinical trial, its use is being evaluated for inguinal or femoral hernia repair surgeries. The current status in medical literature suggests that antibiotic prophylaxis is commonly used to prevent surgical site infections, although this trial aims to assess if it is necessary. The main therapeutic indication is the prevention of infections following surgery. Antibiotics work by targeting and inhibiting the growth of bacteria, either by disrupting their cell wall synthesis or interfering with their protein production. They are classified pharmacologically as antibacterial agents.

Investigated diseases

Inguinal or Femoral Hernia – An inguinal hernia occurs when tissue, such as part of the intestine, protrudes through a weak spot in the abdominal muscles, often resulting in a noticeable bulge in the groin area. A femoral hernia is similar but occurs lower in the groin, where the femoral artery and vein pass into the leg. Both types of hernias can cause discomfort, especially when bending over, coughing, or lifting. They may develop gradually over time and can become more pronounced with physical activity or straining. While they may not always cause pain, they can lead to complications if left untreated. The progression of these hernias can vary, with some remaining stable while others may enlarge or lead to more serious issues.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507319-36-00Estimated enrolment518 patientsSponsorHospital Universitario De Mostoles

sourced from the EU Clinical Trials Register and site verification

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