Recruiting

Antimicrobial Prophylaxis

Sponsor:

Université de Montréal

Code:

NCT02996656

Conditions

Propionibacterium Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cefazolin

Ceftriaxone

Study Details

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

Conditions

Propionibacterium Infection

Study ID

NCT02996656

Start date

Dec, 2016

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Cefazolin

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.

experimental: Ceftriaxone

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.

Interventions

Cefazolin

Antibiotic that will be give before a Trauma or elective open shoulder surgery

Ceftriaxone

Antibiotic that will be give before a Trauma or elective open shoulder surgery

Primary outcome measure

  • Skin Biopsy [ Time Frame: At the initial surgery ]

Central Contacts and Locations

Central contacts

Locations

Hôpital du Sacré-Cœur de Montréal

Recruiting

Montreal, Quebec, Canada, H4J 1C5

Contacts

More Information

Sponsor

Université de Montréal

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Montréal on 2026-05-01.