Antibiotic Prophylaxis for Shoulder Surgery Infection

(PAPA Trial)

Recruiting at 1 trial location

Overseen By Dominique Rouleau, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Montréal

Must not be taking: Antibiotics, Acne treatments

Disqualifiers: Active infection, Liver failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: At the time of surgery

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the antibiotic Ceftriaxone is more effective than Cefazolin at preventing infections during shoulder surgeries. It targets infections caused by P. acnes, a skin bacteria that can lead to post-surgical complications. The trial includes two groups: one receiving Cefazolin, a common antibiotic for these procedures, and the other receiving Ceftriaxone, which may offer greater effectiveness. Candidates for this trial should have healthy skin on their shoulders and should not have used antibiotics or certain skin treatments in the past three months. As an unphased trial, it provides participants the chance to contribute to valuable research that could enhance surgical outcomes.

Do I need to stop my current medications to join the trial?

The trial requires that you have not used antibiotics or treated your skin with antibiotic gel, alcohol gel, cream, or acne treatment in the last three months. If you are currently using these, you would need to stop before joining.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have linked Cefazolin to fewer shoulder joint infections compared to some other antibiotics. Surgeons often use it during procedures to prevent infections, and it is generally well-tolerated. Patients taking Cefazolin experienced fewer infections than those who did not use it or used other antibiotics.

Similarly, Ceftriaxone has shown positive results. Research indicates that patients who received Ceftriaxone had lower infection rates compared to those who didn't receive any antibiotic, suggesting its effectiveness in preventing infections.

Both antibiotics have been used safely in patients, demonstrating they are generally well-tolerated. However, side effects can occur, so discussing any concerns with the medical team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer new approaches to preventing infections during shoulder surgery. Cefazolin, a first-generation cephalosporin, is already a standard option, targeting gram-positive bacteria and some gram-negative ones. However, Ceftriaxone is making waves as it's a third-generation cephalosporin with a broader range, tackling more types of bacteria, including anaerobes like P. acnes. This makes it a promising alternative, potentially reducing postoperative infections without the need for repeated doses during surgery.

What evidence suggests that this trial's treatments could be effective for preventing shoulder surgery infections?

Research has shown that Cefazolin, which participants in this trial may receive, is commonly used to prevent infections during surgery. One study found that patients who received Cefazolin before surgery did not develop infections at the incision site. However, the study also indicated that the risk of needing another surgery due to infection was low regardless of the antibiotic used, suggesting that different antibiotics might be similarly effective.

Ceftriaxone is another antibiotic option in this trial that can combat a wide range of bacteria, including those often causing infections in shoulder surgeries. Some studies suggest it works well when combined with other antibiotics, like vancomycin, to prevent infections in high-risk patients. Although direct comparisons for shoulder surgeries are limited, its broad antibacterial capability makes it a promising option. ^{1 3 4 6 7}

Who Is on the Research Team?

Dominique Rouleau, MD

Principal Investigator

Université de Montréal

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am either male or female.

My shoulder skin is healthy and normal.

Exclusion Criteria

I do not have any infections, including at surgery sites.

My shoulder has been treated with radiation before.

I have not used antibiotics or treated my skin with antibiotic or acne treatments in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Cefazolin or Ceftriaxone as prophylactic antibiotics during open shoulder surgery

At the time of surgery

1 visit (in-person)

Follow-up

Participants are monitored for infection and other outcomes for one year following surgery

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Cefazolin
• Ceftriaxone

Trial Overview 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.

How Is the Trial Designed?

Group I: Ceftriaxone Experimental Treatment 1 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: Cefazolin Active Control 1 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.

Who Is Running the Clinical Trial?

Université de Montréal

Lead Sponsor

Trials

223

Recruited

104,000+

Stryker Trauma and Extremities

Industry Sponsor

Trials

57

Recruited

14,900+

Hopital du Sacre-Coeur de Montreal

Collaborator

Trials

52

Recruited

12,100+

Stryker Trauma GmbH

Industry Sponsor

Trials

56

Recruited

14,800+

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

Collaborator

Trials

17

Recruited

4,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12558903/

Infection prevention strategies in shoulder surgery For prophylaxis, 89% used cefazolin and 10% used clindamycin pre-arthroscopy, versus 84% who used cefazolin and 60% vancomycin pre-arthroplasty; ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666638325002270

Preoperative antibiotic prophylaxis in primary shoulder ... The present data suggests that vancomycin is likely superior to clindamycin for prevention of PJI in patients who cannot receive cefazolin due ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2301401

Trial of Vancomycin and Cefazolin as Surgical Prophylaxis ... The addition of vancomycin to cefazolin prophylaxis was not superior to placebo for the prevention of surgical-site infections in arthroplasty.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10512619/

Incidence of Surgical Site Infection Despite Preoperative ... In this study, none of the patients who were administered cefazolin (N=195) before surgery developed any surgical infection at the incision site ...

5. injuryjournal.com injuryjournal.com/article/S0020-1383(25)00075-0/fulltext

Cefazolin vs. alternative beta-lactams for prophylaxis in ... Risk of reoperation for SSI within 30 days was low and similar between cefazolin (0.31 %) and alternatives (0.37 %). •. The results remained ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35188900/

Antibiotic Prophylaxis with Cefazolin Is Associated ... Cefazolin administration was associated with a significantly lower rate of PJI compared with non-cefazolin alternatives, including both vancomycin and ...

7. jsesinternational.org jsesinternational.org/article/S2666-6383(25)00227-0/fulltext

Preoperative Antibiotic Prophylaxis in Primary Shoulder ... Antibiotic prophylaxis with cefazolin is associated with lower shoulder periprosthetic joint infection rates than non-cefazolin alternatives.