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

2016-12-19 20:38:22 | BioPortfolio

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Propionibacterium Infection

Intervention

Cefazolin, Ceftriaxone

Status

Not yet recruiting

Source

Université de Montréal

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-12-19T20:38:22-0500

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Medical and Biotech [MESH] Definitions

A species of Propionibacterium that occurs in raw milk and cheese. It produces ANTI-INFECTIVE AGENTS and ANTI-INFLAMMATORY AGENTS and is used as a PROBIOTIC.

A broad-spectrum cephalosporin antibiotic with a very long half-life and high penetrability to meninges, eyes and inner ears.

A semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis. It attains high serum levels and is excreted quickly via the urine.

A bacteria isolated from normal skin, intestinal contents, wounds, blood, pus, and soft tissue abscesses. It is a common contaminant of clinical specimens, presumably from the skin of patients or attendants.

A genus of gram-positive, rod-shaped bacteria whose cells occur singly, in pairs or short chains, in V or Y configurations, or in clumps resembling letters of the Chinese alphabet. Its organisms are found in cheese and dairy products as well as on human skin and can occasionally cause soft tissue infections.

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