Preventing Propionibacterium acnes skin colonization before open shoulder surgery
Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery: A Double Blinded Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Université de Montréal Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT02996656 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Montreal, Quebec
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.