Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery (PAPA)
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- STATUS
- Recruiting
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- End date
- Dec 20, 2022
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- participants needed
- 88
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- sponsor
- Université de Montréal
Summary
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
Description
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.
Details
| Condition | Propionibacterium Infection |
|---|---|
| Treatment | Cefazolin, ceftriaxone |
| Clinical Study Identifier | NCT02996656 |
| Sponsor | Université de Montréal |
| Last Modified on | 27 January 2022 |
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