Clinical trial NCT02996656: Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery
Official title: Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery: A Double Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Propionibacterium Infection
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: Stryker Trauma and Extremities
name: Hopital du Sacre-Coeur de Montreal
First posted: 2016-12-19
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

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.

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

Primary outcomes:
measure: Skin Biopsy
timeFrame: At the initial surgery
Secondary outcomes:
measure: MRSA observance
timeFrame: 1 year following the surgery
measure: Infection
timeFrame: 1 year following the surgery
measure: Infection #2
timeFrame: 1 year following the surgery
measure: Infection #3
timeFrame: 1 year following the surgery
measure: Infection #4
timeFrame: 1 year following the surgery
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Hôpital du Sacré-Cœur de Montréal
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Dominique Rouleau, MD
role: PRINCIPAL_INVESTIGATOR
References: