Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery

  • STATUS
    Recruiting
  • End date
    Dec 24, 2022
  • participants needed
    88
  • sponsor
    Université de Montréal
Updated on 24 January 2021

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 IdentifierNCT02996656
SponsorUniversité de Montréal
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Propionibacterium Infection?
Do you have any of these conditions: Do you have Propionibacterium Infection??
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
Clear my responses

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