Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cefazolin, Ceftriaxone.
- Who it may be relevant to
- Registry conditions: Propionibacterium Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery: A Double Blinded Randomized Controlled Trial
Overview
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
Detailed 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.
Interventions
- Drug Cefazolin
Antibiotic that will be give before a Trauma or elective open shoulder surgery - Drug Ceftriaxone
Antibiotic that will be give before a Trauma or elective open shoulder surgery
Primary outcome measures
- Skin Biopsy [Time frame: At the initial surgery]
Secondary outcome measures (5)
- MRSA observance [Time frame: 1 year following the surgery]
- Infection [Time frame: 1 year following the surgery]
- Infection #2 [Time frame: 1 year following the surgery]
- Infection #3 [Time frame: 1 year following the surgery]
- Infection #4 [Time frame: 1 year following the surgery]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Canada · 1 center
- Hôpital du Sacré-Cœur de Montréal — Montreal
Identifiers
NCT: NCT02996656 · PAPA