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Cephalosporin Antibiotic
Antibiotic Prophylaxis for Shoulder Surgery Infection (PAPA Trial)
N/A
Recruiting
Led By Dominique Rouleau, MD
Research Sponsored by Université de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years and older
Presenting normal skin on the shoulder aria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year following the surgery
Awards & highlights
PAPA Trial Summary
This trial will compare the effectiveness of two different antibiotics for preventing infection in shoulder surgery.
Who is the study for?
This trial is for adults with normal skin on the shoulder area who need primary open shoulder surgery. It's not for those who've used antibiotics or acne treatments in the last three months, have active infections, prior radiotherapy to the shoulder, allergies to study drugs, open fractures, or severe liver or kidney issues.Check my eligibility
What is being tested?
The study aims to find out if Ceftriaxone is better than Cefazolin at preventing P. acnes infection during primary shoulder surgery. Participants will receive one of these antibiotics as a preventive measure before their surgery.See study design
What are the potential side effects?
Possible side effects from Cefazolin and Ceftriaxone include allergic reactions, gastrointestinal upset like diarrhea or nausea, blood clotting problems, and rarely serious skin reactions.
PAPA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My shoulder skin is healthy and normal.
PAPA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year following the surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year following the surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Skin Biopsy
Secondary outcome measures
Infection
Infection #2
Infection #3
+2 moreSide effects data
From 2021 Phase 4 trial • 32 Patients • NCT0421869512%
Decompensated cirrhosis
6%
Rectus sheath hematoma
6%
hyperkalemia
6%
Possible gastrointestinal bleed
6%
Hepatic Failure
6%
Pruritus with rash
6%
Hepatic Encephalopathy
6%
Nausea
6%
UTI
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Treatment
PAPA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CeftriaxoneExperimental Treatment1 Intervention
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 II: CefazolinActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceftriaxone
2019
Completed Phase 4
~5020
Find a Location
Who is running the clinical trial?
Hopital du Sacre-Coeur de MontrealOTHER
51 Previous Clinical Trials
12,181 Total Patients Enrolled
Stryker Trauma GmbHIndustry Sponsor
55 Previous Clinical Trials
15,119 Total Patients Enrolled
Université de MontréalLead Sponsor
214 Previous Clinical Trials
102,683 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any infections, including at surgery sites.My shoulder has been treated with radiation before.I am 18 years old or older.I have not used antibiotics or treated my skin with antibiotic or acne treatments in the last 3 months.I am either male or female.My condition is life-threatening or could cause me to lose a limb.I have a broken bone that is exposed through my skin.I do not have liver or kidney failure.My shoulder skin is healthy and normal.
Research Study Groups:
This trial has the following groups:- Group 1: Cefazolin
- Group 2: Ceftriaxone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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