An interventional study of Cefazolin and Ceftriaxone in Propionibacterium Infection, sponsored by Université de Montréal. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Université de Montréal · Not applicable, Interventional, and Prevention
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
This is a double blinded randomized clinical trial comparing two different prophylactic antibiotics used for primary open shoulder surgery. The participants are volunteer patients scheduled for a primary open elective or trauma shoulder surgery. Patients with positive MRSA screening test will be excluded from the randomised study as they will receive vancomycin for prophylaxis. If they accept to participate, they will be included in the observational MRSA+ arm. The investigators will take from the participants the same data as the randomised patients and the investigators will take biopsies.
4 equals group will be form: Female-elective: 22 envelops, 11 cefazolin, 11 ceftriaxone in a randomly order Female-trauma: 22 envelops, 11 cefazolin, 11 ceftriaxone in a randomly order Male-elective: 22 envelops, 11 cefazolin, 11 ceftriaxone in a randomly order Male-trauma: 22 envelops, 11 cefazolin, 11 ceftriaxone in a randomly order The surgeons, anesthesiologist, patients and laboratory technician, microbiologist will be blinded to the antibiotics received by the patient.
Université de Montréal is the lead sponsor of 98 studies on the registry; 11 are open to participants now.
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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.
Drug: Cefazolin
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.
Drug: Ceftriaxone
Antibiotic that will be give before a Trauma or elective open shoulder surgery
Antibiotic that will be give before a Trauma or elective open shoulder surgery
Skin Biopsy
Number of bacteria identified in five skin biopsies taken at the surgical site
Time frame: At the initial surgery
MRSA observance
Observe the patients from de MRSA group which will be receiving Vancomycin as prophylactic antibiotics.
Time frame: 1 year following the surgery
Infection
Assessing the appearance of C Difficile infection at 1 year post-op
Time frame: 1 year following the surgery
Infection #2
Assessing the appearance of resistant pathogens colonization (MRSA, VRE, Multiresistant Gram negative Bacillus) 1 year post-op
Time frame: 1 year following the surgery
Infection #3
Follow all the participants for one year to observe superficial tissue infection (as defined by the infection prevention team of Montreal Sacre-Coeur Hospital
Time frame: 1 year following the surgery
Infection #4
Follow all the participants for one year to observe deep tissue infection (as defined by the infection prevention team of Montreal Sacre-Coeur Hospital)
Time frame: 1 year following the surgery
Plan to share: Undecided
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Studies of the drug tested here: Ceftriaxone
Université de Montréal