AuthorisedTherapeutic confirmatory (Phase III)Interventional

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

This research study is investigating an important question about groin hernia operations: is it really necessary to give antibiotics beforehand to prevent infections? Currently, some patients receive an antibiotic called Cefazolin before their surgery. This study aims to find out if patients who don't receive these antibiotics have the same low risk of infection as those who do. By answering this, doctors hope to reduce unnecessary antibiotic use, which is good for patients and helps fight antibiotic resistance. The study is for adults aged 18 and over who are having an inguinal or femoral hernia repair.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Hospital Universitario De Mostoles

Enrolment target

518

Start

05 Feb 2024

Inguinal or femoral hernia

What is this study about?

This study is all about understanding the best way to prevent infections after a common operation called a hernia repair. A hernia happens when a part of your body (like your intestine) pushes through a weak spot in a muscle or tissue. The most common types are inguinal (inner groin) and femoral (outer groin/upper thigh) hernias. Surgery is usually needed to fix them.

Sometimes, before an operation, doctors give patients antibiotics as a precaution to stop infections from developing. This is called 'antibiotic prophylaxis'. The drug being looked at in this study is called Cefazolin, which is a common antibiotic. Doctors want to know if giving this antibiotic before a groin hernia operation is always necessary, or if many patients would be just as safe and recover well without it.

The main goal is to improve patient care. If it's found that antibiotics aren't always needed for these specific hernia operations, it could mean fewer people are exposed to antibiotics unnecessarily. This is good because it can reduce side effects from antibiotics and also helps in the bigger fight against 'antibiotic resistance', where germs learn to beat medicines.

Key takeaways

Researchers are studying whether antibiotics are always needed before groin hernia surgery.
The study aims to improve patient care and reduce unnecessary antibiotic use.
Participation involves either receiving the antibiotic Cefazolin or not, before surgery.
All adults (18+) having an inguinal or femoral hernia repair can be considered.
Your medical care isn't affected by joining or leaving the study.

Who may be eligible?

To take part in this study, you need to be an adult, meaning you must be 18 years old or older. There is no upper age limit, so people of all adult ages can be considered. Both men and women are welcome to participate.

The main requirement is that you are scheduled to have surgery to fix a groin hernia. This includes both inguinal hernias (in the inner groin area) and femoral hernias (in the upper thigh or outer groin area).

If you have any other serious health conditions or are taking certain medications, these might affect whether you can join, but the basic requirements are simply being an adult scheduled for this type of hernia surgery.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having surgery for an inguinal hernia (inner groin)?
Are you having surgery for a femoral hernia (outer groin/upper thigh)?
Are you able to attend follow-up appointments after surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part, what happens next will depend on which group you are put into. Some patients will receive the antibiotic Cefazolin through a small drip into a vein just before their hernia surgery, as is sometimes done normally. Other patients will not receive this antibiotic. You will not know which group you are in until after your surgery. All other aspects of your surgery and recovery care will be exactly the same.

After your surgery, the doctors will carefully monitor you to see if you develop any infections around the area where you had your operation. This will likely involve a few check-ups, which might be in person or by phone, over a certain period after your surgery to make sure you are healing well. The total duration of your participation will depend on how long the doctors need to watch for any signs of infection, but it will be explained in detail before you agree to join.

Potential risks and benefits

Taking part in this study may or may not directly benefit you, but the information gathered will help improve future treatment for many patients. You might be less likely to experience side effects from antibiotics if you are in the group that doesn't receive them. Potential risks include the chance of developing a surgical site infection, as with any surgery, though researchers believe the risk is similar whether or not antibiotics are given. If you do develop an infection, it will be treated as normal. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is a hernia?

A hernia is when an organ or fatty tissue squeezes through a weak spot in a surrounding muscle or tissue. Groin hernias (inguinal and femoral) are common types that usually need surgery.

What are antibiotics for?

Antibiotics are medicines used to fight bacterial infections. In this study, they're being considered as a preventive measure before surgery.

What is 'antibiotic resistance'?

This is when bacteria change and become able to defeat the antibiotics designed to kill them. Reducing unnecessary antibiotic use helps slow down resistance.

Will I know if I'm getting the antibiotic?

No, you won't know whether you received the antibiotic or not until after your surgery. This helps ensure fair results for the study.

Is my general medical care affected by joining?

No, your standard care for your hernia and ongoing health will not be affected regardless of whether you join or withdraw from the study.