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

Propionibacterium Infection Clinical Trial

— PAPA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02996656
• Other study ID #: PAPA
• Status: Recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Université de Montréal
• Contact: Dominique Rouleau, MD
• Phone: 514-338-2222
• Email: dominique_rouleau[@]yahoo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Propionibacterium Infection

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	Hôpital du Sacré-Cœur de Montréal	Montréal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Université de Montréal	Hopital du Sacre-Coeur de Montreal, Stryker Trauma GmbH

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin Biopsy	Number of bacteria identified in five skin biopsies taken at the surgical site	At the initial surgery
Secondary	MRSA observance	Observe the patients from de MRSA group which will be receiving Vancomycin as prophylactic antibiotics.	1 year following the surgery
Secondary	Infection	Assessing the appearance of C Difficile infection at 1 year post-op	1 year following the surgery
Secondary	Infection #2	Assessing the appearance of resistant pathogens colonization (MRSA, VRE, Multiresistant Gram negative Bacillus) 1 year post-op	1 year following the surgery
Secondary	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
Secondary	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