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

Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery: A Double Blinded Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Propionibacterium Infection
• Intervention / Treatment: Drug: Cefazolin; Drug: Ceftriaxone

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.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominique Rouleau, MD; Phone Number: 3427 514-338-2222; Email: dominique_rouleau@yahoo.ca
• Study Contact Backup: Name: Karine Tardif; Phone Number: 3465 514-338-2222; Email: karinetardif2@gmail.com

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • Recruiting
      • Hopital du Sacre-Coeur de Montreal
      • Contact: Karine Tardif; Phone Number: 3465 514-338-2222; Email: karinetardif2@gmail.com
      • Contact: Dominique Rouleau; Phone Number: 2050 514-338-2222; Email: dominique_rouleau@yahoo.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Cefazolin; Antibiotic that will be give before a Trauma or elective open shoulder surgery
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.	Drug: Ceftriaxone; Antibiotic that will be give before a Trauma or elective open shoulder surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Biopsy	Number of bacteria identified in five skin biopsies taken at the surgical site	At the initial surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRSA observance	Observe the patients from de MRSA group which will be receiving Vancomycin as prophylactic antibiotics.	1 year following the surgery
Infection	Assessing the appearance of C Difficile infection at 1 year post-op	1 year following the surgery
Infection #2	Assessing the appearance of resistant pathogens colonization (MRSA, VRE, Multiresistant Gram negative Bacillus) 1 year post-op	1 year following the surgery
Infection #3	Follow all the participants for one year to observe superficial tissue infection (as defined by the infection prevention team of Montreal Sacre-Coeur Hospital	1 year following the surgery
Infection #4	Follow all the participants for one year to observe deep tissue infection (as defined by the infection prevention team of Montreal Sacre-Coeur Hospital)	1 year following the surgery

Collaborators and Investigators

• Sponsor: Université de Montréal
• Collaborators: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal; Stryker Trauma and Extremities
• Investigators: Principal Investigator: Dominique Rouleau, MD, Université de Montréal

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 25, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (Estimated): December 19, 2016

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amides; beta-Lactams; Lactams; Cephalosporins; Thiazines; Cefotaxime; Cephacetrile; Ceftriaxone; Cefazolin
• Other Study ID Numbers: PAPA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED