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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

P.Acnes Colony Count Following Subdermal Cefazolin

NCT03853096

Surgical Site Infection Microbial Colonization

UNKNOWN EARLY_PHASE1

Can Addition of Doxycycline Perioperatively Reduce Propionibacterium Acnes in Shoulder Arthroplasty?

NCT03115177

Osteoarthritis

COMPLETED NA

Antibiotic Prophylaxis in Clean Surgery. Impact on Surgical Site Infection

NCT03595852

Surgical Site Infection

COMPLETED NA

Antibiotic Prophylaxis in Orthopaedic Traumatology

NCT00610987

Fractures, Closed Wounds and Injuries

COMPLETED NA

Routine Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy

NCT01558986

Surgical Infection

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Propionibacterium Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Cefazolin

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Ceftriaxone

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cefazolin

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

Intervention Type DRUG

Ceftriaxone

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No