Preventing Propionibacterium acnes skin colonization before open shoulder surgery
Official title: Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery: A Double Blinded Randomized Controlled Trial
Run by Université de Montréal · NCT02996656 · Data updated 2026-11-12
This trial will test whether ceftriaxone or cefazolin better prevents Propionibacterium acnes from colonizing the shoulder skin in adults having primary open shoulder surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 88 (estimated) |
| Sponsor | Université de Montréal Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Status | Recruiting |
| Started | December 2016 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT02996656 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with normal shoulder skin who are scheduled for primary open elective or trauma shoulder surgery and who have not used topical or systemic antibiotics or acne treatments in the prior three months are ideal candidates for the randomized arms.
✕Probably not a fit
Patients with active infection, open fractures, recent antibiotic or topical acne treatments, known allergy to the study antibiotics, prior shoulder radiotherapy, severe liver or kidney failure, or documented MRSA colonization (who will receive vancomycin) are unlikely to benefit from the randomized comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a double-blinded, randomized trial comparing a single prophylactic dose of ceftriaxone versus cefazolin in adults undergoing primary open elective or trauma shoulder surgery. Participants with MRSA colonization are excluded from randomization and entered into an observational arm that receives vancomycin, with the same data collection and skin biopsies performed. Randomization is stratified by sex and elective versus trauma cases, and surgeons, anesthesiologists, patients, and laboratory staff are blinded to the assigned antibiotic. The primary outcome is skin colonization by Propionibacterium acnes measured from biopsies taken at the time of surgery.
Why it matters
Potential benefit: If ceftriaxone is more effective, patients could have fewer P. acnes colonization events and a lower risk of subsequent shoulder infections and reoperations.
How similar studies have gone: Standard cefazolin prophylaxis reduces many surgical site infections but P. acnes remains a persistent issue in shoulder surgery, so directly comparing ceftriaxone for this purpose is relatively novel with limited prior evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years and older * Male or female * Presenting normal skin on the shoulder aria Exclusion Criteria: * Used antibiotics or treated their skin with antibiotic gel, alcohol gel or cream or acne treatment in the last three months * Active infection at the surgical site or anywhere * Affected shoulder previously received radiotherapy * Allergic to one of the antimicrobial prophylaxis used * Open fracture * Life threatening or a limb threatening pathology * Liver or kidney failure
Where it's running
-
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Dominique Rouleau, MD — Université de Montréal
- Study coordinator: Dominique Rouleau, MD
- Email: dominique_rouleau@yahoo.ca
- Phone: 514-338-2222
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.