RecruitingNAINTERVENTIONAL

Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery

This study is investigating if a different antibiotic, called Ceftriaxone, is more effective than the standard antibiotic, Cefazolin, in preventing skin infections in patients having shoulder surgery. Skin bacteria, particularly a type called Propionibacterium acnes, can sometimes cause infections after surgery, even when standard skin cleaning and antibiotics are used. Researchers want to find out if Ceftriaxone can reduce the chances of these specific infections better than Cefazolin. They are comparing these two common antibiotics to see which one is best at protecting patients during primary shoulder operations. This research is important because it could lead to better ways to prevent infections and improve patient safety during and after shoulder surgery.

At a glance

Status

Recruiting

Phase

Sponsor

Université de Montréal

Enrolment target

Start

01 Dec 2016

Estimated completion

01 Dec 2026

Propionibacterium Infection

What is this study about?

When you have shoulder surgery, doctors always take steps to prevent infections. One important step is giving antibiotics before the operation. The usual antibiotic given for many surgeries is called Cefazolin. However, doctors have noticed that sometimes, even with Cefazolin and good skin cleaning, some patients still get infections from a common skin bacterium called Propionibacterium acnes after shoulder surgery. This has led doctors to wonder if Cefazolin is really the best antibiotic for preventing this specific type of infection in shoulder operations.

This study wants to explore if another common antibiotic, Ceftriaxone, might be more effective at stopping these particular skin bacteria from causing problems after shoulder surgery. Doctors will compare Ceftriaxone with Cefazolin to see which one works better. By doing this, they hope to find the best possible antibiotic to protect patients from infections during and after their shoulder surgery.

Finding a better way to prevent these infections is really important. It can help reduce complications, ensure a smoother recovery for patients, and potentially lower the need for further treatments related to infections. This research aims to make shoulder surgery even safer for everyone.

Key takeaways

This study compares two common antibiotics to prevent shoulder surgery infections.
It focuses on a specific skin bacterium called Propionibacterium acnes.
The aim is to find out if Ceftriaxone is better than Cefazolin.
You won't know which antibiotic you receive to keep the study fair.
Participation involves receiving one of the study antibiotics during your planned surgery.

Who may be eligible?

To join this study, you need to be 18 years old or older, and you can be male or female. You must be planned for your first open shoulder surgery, whether it's for an injury or a planned procedure, and your skin on your shoulder should look healthy and normal.

There are some reasons why you wouldn't be able to join. For example, if you've used antibiotics or special skin gels or creams in the last three months, or if you're currently dealing with an infection at your surgery site or elsewhere in your body, you won't be able to take part. Also, if you've had radiation treatment on your shoulder before, or if you're allergic to any of the antibiotics being tested, you wouldn't be suitable.

Other reasons for not being able to participate include having a severe injury where the bone is exposed, having a life-threatening illness or problems with your liver or kidneys. If you have been identified as having a type of bacteria called MRSA, you will still receive special care but would not be part of the main comparison in this study.

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 your first open shoulder surgery?
Is the skin on your shoulder healthy?
Have you avoided antibiotics or special skin treatments in the last three months?
Do you have good liver and kidney health?
Are you not allergic to Cefazolin or Ceftriaxone?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to receive one of two antibiotics – Cefazolin or Ceftriaxone – just before your shoulder surgery. Neither you nor your surgeons or other medical staff will know which antibiotic you're getting; this is done to ensure the study results are fair and unbiased. During your surgery, small samples of tissue will be taken from your shoulder. These samples will be checked in a lab to see if any bacteria, like Propionibacterium acnes, are present even with the antibiotic.

The study involves having your surgery as planned, with the additional step of receiving one of the two study antibiotics. There are no extra visits specifically for the study. The total duration of your participation will cover your surgery and the lab analysis of the tissue samples. This study will not change your usual post-surgery follow-up care provided by your medical team.

Potential risks and benefits

Participating in this study might offer the benefit of potentially receiving an antibiotic that is more effective at preventing surgical infections before it becomes a standard treatment. However, there's also a chance you might receive an antibiotic that turns out to be less effective than the other for this specific purpose. As with any medication, there's a small risk of side effects from the antibiotics, though these are both commonly used medications. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Hôpital du Sacré-Cœur de Montréal
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is Propionibacterium acnes?

It's a common type of bacteria that lives on our skin, often linked to acne, but it can sometimes cause infections after surgery, especially in the shoulder.

What's the main goal of this study?

The main goal is to find out if a different antibiotic, Ceftriaxone, works better than the usual one, Cefazolin, to prevent skin infections during shoulder surgery.

Will I know which antibiotic I receive?

No, neither you nor your doctors will know which antibiotic you received. This is called 'double-blinded' and helps make the study results very fair.

Are these antibiotics new or experimental?

No, both Cefazolin and Ceftriaxone are common, approved antibiotics that doctors use regularly for various infections or to prevent them.

Will taking part in the study change my surgery?

No, your surgery will proceed as planned. The only difference is that you'll receive one of the study antibiotics just before your operation.

How to find out more

Dominique Rouleau, MD

dominique_rouleau@yahoo.ca 514-338-2222 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.