Antibiotic Prophylaxis for Shoulder Surgery Infection (PAPA Trial)

Palo Alto (17 mi)

Overseen byDominique Rouleau, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Recruiting

Sponsor: Université de Montréal

No Placebo Group

Trial Summary

What is the purpose of this trial?INESS Antibiotic Prophylaxis in Orthopedic Guide recommends the use of Cefazolin at induction for all orthopaedic procedure with implantation of internal fixation device. With the increasing rate of identified P. acnes shoulder surgery infection despite the use of recommended skin preparation and preoperative prophylactic antibiotics, a question arises; Is Cefazolin the most effective prophylactic antibiotic for shoulder surgery? The objective of this study is to determine if Ceftriaxone is superior to Cefazolin as a prophylactic antibiotic for skin colonization with P. acnes in primary shoulder surgery

Eligibility Criteria

This trial is for adults with normal skin on the shoulder area who need primary open shoulder surgery. It's not for those who've used antibiotics or acne treatments in the last three months, have active infections, prior radiotherapy to the shoulder, allergies to study drugs, open fractures, or severe liver or kidney issues.

Inclusion Criteria

I am 18 years old or older.

My shoulder skin is healthy and normal.

Exclusion Criteria

I do not have any infections, including at surgery sites.

My shoulder has been treated with radiation before.

My condition is life-threatening or could cause me to lose a limb.

I have a broken bone that is exposed through my skin.

I do not have liver or kidney failure.

Treatment Details

The study aims to find out if Ceftriaxone is better than Cefazolin at preventing P. acnes infection during primary shoulder surgery. Participants will receive one of these antibiotics as a preventive measure before their surgery.

2Treatment groups

Experimental Treatment

Active Control

Group I: CeftriaxoneExperimental Treatment1 Intervention

During an open shoulder surgery, the Ceftriaxone will be administered to some patient. The Ceftriaxone is a third generation cephalosporin. It targets gram positive cocci such as staphylococcus and streptococcus, gram negative bacilli and some anaerobes, including P. acnes. The prophylactic dose is of 2g IV given a minimum of 30 minutes prior to skin incision. It is effective 12h so no other dose is needed during surgery.

Group II: CefazolinActive Control1 Intervention

During an open shoulder surgery, the Cefazolin will be administered to some patient. The Cefazolin is a first generation cephalosporin. It is a beta lactam which targets gram positive cocci and some gram negative bacilli. The INESS Antibiotic Prophylaxis in Orthopedic Guide recommends the use of Cefazolin at induction for all orthopaedic procedure with implantation of internal fixation device. The dosage is 2g intravenous if the patient weights less than 120kg or 3g if the patient weights more than 120kg. The dose should be repeated if the procedure lasts for more than three hours or if the blood loss is greater than 1500mL.