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| Name | Class |
|---|---|
| Stryker Trauma and Extremities | INDUSTRY |
| Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cefazolin | Active Comparator | During an open shoulder surgery, the Cefazolin will be administered to some patient. The Cefazolin is a first generation cephalosporin. It is a beta lactam which targets gram positive cocci and some gram negative bacilli. The INESS Antibiotic Prophylaxis in Orthopedic Guide recommends the use of Cefazolin at induction for all orthopaedic procedure with implantation of internal fixation device. The dosage is 2g intravenous if the patient weights less than 120kg or 3g if the patient weights more than 120kg. The dose should be repeated if the procedure lasts for more than three hours or if the blood loss is greater than 1500mL. |
|
| Ceftriaxone | Experimental | During an open shoulder surgery, the Ceftriaxone will be administered to some patient. The Ceftriaxone is a third generation cephalosporin. It targets gram positive cocci such as staphylococcus and streptococcus, gram negative bacilli and some anaerobes, including P. acnes. The prophylactic dose is of 2g IV given a minimum of 30 minutes prior to skin incision. It is effective 12h so no other dose is needed during surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefazolin | Drug | Antibiotic that will be give before a Trauma or elective open shoulder surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin Biopsy | Number of bacteria identified in five skin biopsies taken at the surgical site | At the initial surgery |
| Measure | Description | Time Frame |
|---|---|---|
| MRSA observance | Observe the patients from de MRSA group which will be receiving Vancomycin as prophylactic antibiotics. | 1 year following the surgery |
| Infection | Assessing the appearance of C Difficile infection at 1 year post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique Rouleau, MD | Contact | 514-338-2222 | 3427 | dominique_rouleau@yahoo.ca |
| Karine Tardif | Contact | 514-338-2222 | 3465 | karinetardif2@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dominique Rouleau, MD | Université de Montréal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital du Sacré-Cœur de Montréal | Recruiting | Montreal | Quebec | H4J 1C5 | Canada |
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| ID | Term |
|---|---|
| D002437 | Cefazolin |
| D002443 | Ceftriaxone |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Ceftriaxone | Drug | Antibiotic that will be give before a Trauma or elective open shoulder surgery |
|
| 1 year following the surgery |
| Infection #2 | Assessing the appearance of resistant pathogens colonization (MRSA, VRE, Multiresistant Gram negative Bacillus) 1 year post-op | 1 year following the surgery |
| 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 | 1 year following the surgery |
| Infection #4 | Follow all the participants for one year to observe deep tissue infection (as defined by the infection prevention team of Montreal Sacre-Coeur Hospital) | 1 year following the surgery |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |