Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, H4J 1C5, Canada
Location status: Recruiting
NCT Number: NCT02996656
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Montreal, Quebec, H4J 1C5, Canada
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Antibiotic that will be give before a Trauma or elective open shoulder surgery
Antibiotic that will be give before a Trauma or elective open shoulder surgery
Time frame: At the initial surgery
Number of bacteria identified in five skin biopsies taken at the surgical site
Time frame: 1 year following the surgery
Observe the patients from de MRSA group which will be receiving Vancomycin as prophylactic antibiotics.
Time frame: 1 year following the surgery
Assessing the appearance of C Difficile infection at 1 year post-op
Time frame: 1 year following the surgery
Assessing the appearance of resistant pathogens colonization (MRSA, VRE, Multiresistant Gram negative Bacillus) 1 year post-op
Time frame: 1 year following the surgery
Follow all the participants for one year to observe superficial tissue infection (as defined by the infection prevention team of Montreal Sacre-Coeur Hospital
Time frame: 1 year following the surgery
Follow all the participants for one year to observe deep tissue infection (as defined by the infection prevention team of Montreal Sacre-Coeur Hospital)
Contact information is provided by the study sponsor or research team.
Université de Montréal
Other
Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery: A Double Blinded Randomized Controlled Trial
Acronym: PAPA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03158766
Bone Diseases, Bone Diseases, Infectious
São Paulo, Brazil
View Trial Details