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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02996656
Acronym
PAPA
Enrollment
88
Registered
2016-12-19
Start date
2016-12-01
Completion date
2026-12-01
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Propionibacterium Infection

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

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.

Interventions

DRUGCefazolin

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

DRUGCeftriaxone

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

Sponsors

Université de Montréal
Lead SponsorOTHER
Stryker Trauma and Extremities
CollaboratorINDUSTRY
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Skin BiopsyAt the initial surgeryNumber of bacteria identified in five skin biopsies taken at the surgical site

Secondary

MeasureTime frameDescription
MRSA observance1 year following the surgeryObserve the patients from de MRSA group which will be receiving Vancomycin as prophylactic antibiotics.
Infection1 year following the surgeryAssessing the appearance of C Difficile infection at 1 year post-op
Infection #21 year following the surgeryAssessing the appearance of resistant pathogens colonization (MRSA, VRE, Multiresistant Gram negative Bacillus) 1 year post-op
Infection #31 year following the surgeryFollow all the participants for one year to observe superficial tissue infection (as defined by the infection prevention team of Montreal Sacre-Coeur Hospital
Infection #41 year following the surgeryFollow all the participants for one year to observe deep tissue infection (as defined by the infection prevention team of Montreal Sacre-Coeur Hospital)

Countries

Canada

Contacts

CONTACTDominique Rouleau, MD
dominique_rouleau@yahoo.ca514-338-2222
CONTACTKarine Tardif
karinetardif2@gmail.com514-338-2222
PRINCIPAL_INVESTIGATORDominique Rouleau, MD

Université de Montréal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026