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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversité de Montréal

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years and older

Male or female

Presenting normal skin on the shoulder aria

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: CefazolinActive comparator 1 intervention
Group B: CeftriaxoneExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Skin Biopsy

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

Time frame
At the initial surgery

Secondary outcomes

1

MRSA observance

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

Time frame
1 year following the surgery
2

Infection

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

Time frame
1 year following the surgery
3

Infection #2

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

Time frame
1 year following the surgery
4

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

Time frame
1 year following the surgery

Other outcomes

Sponsors and contacts

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Université de Montréal

Lead sponsor

Stryker Trauma and Extremities

Collaborator

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Collaborator