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NCT Number: NCT02996656

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cefazolin

Drug

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

Ceftriaxone

Drug

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

Primary outcomes

  1. Skin Biopsy

    Time frame: At the initial surgery

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

Secondary outcomes

  1. MRSA observance

    Time frame: 1 year following the surgery

    Observe the patients from de MRSA group which will be receiving Vancomycin as prophylactic antibiotics.

  2. Infection

    Time frame: 1 year following the surgery

    Assessing the appearance of C Difficile infection at 1 year post-op

  3. Infection #2

    Time frame: 1 year following the surgery

    Assessing the appearance of resistant pathogens colonization (MRSA, VRE, Multiresistant Gram negative Bacillus) 1 year post-op

  4. Infection #3

    Time frame: 1 year following the surgery

    Follow all the participants for one year to observe superficial tissue infection (as defined by the infection prevention team of Montreal Sacre-Coeur Hospital

  5. Infection #4

    Time frame: 1 year following the surgery

    Follow all the participants for one year to observe deep tissue infection (as defined by the infection prevention team of Montreal Sacre-Coeur Hospital)

Study contacts

Contact information is provided by the study sponsor or research team.

Dominique Rouleau, MD

CONTACT

[email protected]

514-338-2222 ext. 3427

Karine Tardif

CONTACT

[email protected]

514-338-2222 ext. 3465

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Collaborators

  • Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
  • Stryker Trauma and Extremities

Registry information

Official study title

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

Acronym: PAPA

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2016
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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