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

NCT02996656 | Recruiting

• 1 other identifier: PAPA
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Skin Biopsy

  Number of bacteria identified in five skin biopsies taken at the surgical site

  At the initial surgery

Secondary Outcomes (5)

• MRSA observance

  1 year following the surgery

• Infection

  1 year following the surgery

• Infection #2

  1 year following the surgery

• Infection #3

  1 year following the surgery

• Infection #4

  1 year following the surgery

Study Arms (2)

Cefazolin

ACTIVE COMPARATOR

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.

Drug: Cefazolin

Ceftriaxone

EXPERIMENTAL

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.

Drug: Ceftriaxone

Interventions

Cefazolin DRUG

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

Cefazolin

Ceftriaxone DRUG

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

Ceftriaxone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Male or female
• Presenting normal skin on the shoulder aria

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: collaborator
• Université de Montréal: lead
• Stryker Trauma and Extremities: collaborator

Study Sites (1)

Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, H4J 1C5, Canada

RECRUITING

MeSH Terms

Interventions

Cefazolin; Ceftriaxone

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cefotaxime; Cephacetrile

Study Officials

• Dominique Rouleau, MD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique Rouleau, MD

CONTACT

514-338-2222; dominique_rouleau@yahoo.ca

Karine Tardif

CONTACT

514-338-2222; karinetardif2@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic surgeon

Study Record Dates

• First Submitted: November 25, 2016
• First Posted: December 19, 2016
• Study Start: December 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CA (1)