About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years and older
Male or female
Presenting normal skin on the shoulder aria
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Cefazolin
DrugAntibiotic that will be give before a Trauma or elective open shoulder surgery
Ceftriaxone
DrugAntibiotic that will be give before a Trauma or elective open shoulder surgery
Treatment groups
Trial outcomes
Primary outcomes
Skin Biopsy
Number of bacteria identified in five skin biopsies taken at the surgical site
Secondary outcomes
MRSA observance
Observe the patients from de MRSA group which will be receiving Vancomycin as prophylactic antibiotics.
Infection
Assessing the appearance of C Difficile infection at 1 year post-op
Infection #2
Assessing the appearance of resistant pathogens colonization (MRSA, VRE, Multiresistant Gram negative Bacillus) 1 year post-op
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
Sponsors and contacts
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Université de Montréal
Lead sponsor
Stryker Trauma and Extremities
Collaborator
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Collaborator