Cefazolin for Surgical Site Infection
(CALIPSO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of cefazolin, an antibiotic, in preventing infections after heart surgery. Researchers will compare three approaches: administering cefazolin only during surgery, continuing it for 24 hours afterward, or extending it to 48 hours. The goal is to determine which method best prevents surgical site infections and related issues while minimizing unnecessary medication use. Participants should be adults undergoing heart surgery that involves opening the chest, known as a median sternotomy. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand its benefits for a broader patient population.
What is the safety track record for cefazolin?
Research has shown that cefazolin is generally safe for preventing infections after surgery. In one study, patients who received cefazolin experienced fewer surgical site infections compared to those who received other treatments. Specifically, only 0.9% of patients in the cefazolin group developed infections, significantly lower than the 3.8% in another treatment group. Another study found that cefazolin, used as a preventive antibiotic in various surgeries, was well-tolerated by patients.
These studies suggest that cefazolin is well-tolerated and can effectively reduce the risk of infections after surgery. While some studies did not find a significant benefit for certain types of surgeries, the overall evidence supports its safety. Since the FDA has already approved cefazolin for other uses, its safety in humans is well-documented.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the use of cefazolin for surgical site infections because it offers a precise approach to antimicrobial prophylaxis. Unlike standard treatments that often involve a one-size-fits-all dosing schedule, this trial explores varying durations of cefazolin administration to optimize protection against infections. By tailoring the dosing schedule, researchers aim to maximize efficacy while potentially reducing unnecessary antibiotic exposure. This could lead to a more personalized and effective method for preventing infections after surgery.
What evidence suggests that this trial's treatments could be effective for preventing surgical site infections?
Studies have shown that cefazolin reduces infections at surgical sites in various operations. Specifically, it significantly lowered infection risk in planned spine surgeries. Research indicates that cefazolin is often recommended during surgery due to its effectiveness against common bacteria. However, some studies suggest that a single dose before surgery might not suffice, depending on the surgery type. This trial will compare different cefazolin dosing regimens: intraoperative only, intraoperative with 24-hour postoperative, and intraoperative with 48-hour postoperative administration, to evaluate its effectiveness in preventing surgical site infections. Overall, cefazolin is generally considered safe and effective for this purpose.46789
Who Is on the Research Team?
Trisha Peel, MBBS GradCertRes FRACP PhD
Principal Investigator
Monash University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intraoperative and postoperative antimicrobial prophylaxis with cefazolin or placebo for up to 48 hours
Follow-up
Participants are monitored for surgical site infections and other health outcomes
Extended Follow-up
Participants are monitored for all-cause mortality and other long-term outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Cefazolin
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Placebo Group
Cefazolin (2g) administered 8-hourly following the preoperative dose (time=0) for two doses then placebo 8-hourly for three doses (total of 5 postoperative doses of cefazolin/placebo)
Cefazolin (2g) administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses
Placebo administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses
Find a Clinic Near You
Who Is Running the Clinical Trial?
Monash University
Lead Sponsor
The Australian and New Zealand College of Anaesthetists (ANZCA)
Collaborator
ANZCA CTN
Collaborator
The Alfred
Collaborator
Citations
Incidence of Surgical Site Infection Despite Preoperative ...
These results are significant because they indicate the effectiveness of cefazolin in preventing surgical infection. In comparison ...
Cefazolin prophylaxis is associated with lower surgical site ...
Cefazolin prophylaxis is associated with significantly lower SSI risk in elective spine procedures. These findings support cefazolin as the preferred ...
3.
contemporaryobgyn.net
contemporaryobgyn.net/view/study-reports-reduced-ssi-odds-after-gynecologic-surgery-from-metronidazole-and-cefazolinStudy reports reduced SSI odds after gynecologic surgery ...
A recent study shows that adding metronidazole to cefazolin significantly lowers the risk of surgical site infections in gynecologic cancer surgeries.
The efficacy of cefazolin in reducing surgical site infection ...
Conclusions: A single dose of preoperative prophylactic cefazolin has no significant benefit in reducing the incidence of SSI in laparoscopic cholecystectomy.
Incidence of surgical infection in cefazolin 3 g versus 2 ...
Overall, these findings suggest that cefazolin 3 g surgical prophylaxis does not have an added benefit over 2 g dosing within obese populations ...
Cefazolin prophylaxis is associated with lower surgical site ...
In the present study, cefazolin-based perioperative antibiotic selection was associated with a 50% to 65% relative reduction in 90-day SSI risk ...
Surgical site infection rate is higher following hip and knee ...
Purpose: While many guidelines recommend higher doses of cefazolin for patients with higher body weights, there are scant outcome data showing ...
1663. Risk-benefit assessment of cefazolin use for surgical ...
The frequency of SSI was lower in the cefazolin group compared to the C/V group (0.9% vs. 3.8%, p < .01). The cefazolin group included 7 SSI, ...
Effect of Antibiotic Prophylaxis on Surgical Site Infections ...
A single preoperative dose of intravenous cefazolin did not reduce the risk of surgical site infection within 30 days following removal of orthopedic implants.
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