Surgical Site InfectionPhase 4NCT04303390
24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis
A Phase 4 study testing Cefuroxime, Cefazolin and 24 hours in people with Surgical Site Infection, run by Saud Al Babtain Cardiac Center at 1 site in Saudi Arabia.
Trial summary
A randomized control trial studying the effect of prophylactic antibiotics to reduce surgical site infections following cardiac surgery in adults using 1st generation cephalosporin (Cefazolin) or 2nd generation cephalosporin (Cefuroxime). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Cefuroxime, Cefazolin and 24 hours
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 568 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 6 Feb 2018to 31 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide informed consent
- Planned to undergo a cardiac surgical procedure
Who cannot join
- Patients on antibiotics on the day of surgery or those who received any within 7 days for any reason
- Patients taken to operating room as salvage
- Patients who are allergic to either cefuroxime or cefazolin
- Patients for LVAD or ECMO
- Patients who are known MRSA carriers
- Patients receiving steroid therapy
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Saud AlBabtain Cardiac Center
Dammam, Eastern Province, 31463
About this study
Official title: 24 Versus 48 Hours of First Generation or Second Generation Cephalosporin as Prophylaxis to Reduce Surgical Site Infection in Adult Cardiac Surgery Patients: a Randomized Controlled Trial
A randomized control trial studying the effect of prophylactic antibiotics to reduce surgical site infections following cardiac surgery in adults using 1st generation cephalosporin (Cefazolin) or 2nd generation cephalosporin (Cefuroxime).
Read the detailed description
A prospective randomized controlled patient blinded study with 2x2 factional design. It aims to study optimal duration of antibiotic to reduce surgical site infections following cardiac surgery in adults 24 or 48 hours using 1st generation cephalosporin (Cefazolin) or 2nd generation cephalosporin (Cefuroxime). Patients shall remain on either medicines for 24 or 48 hours. The primary endpoints of the study are:(1) 48 hours antibiotic prophylaxis is superior to 24 hours in adult cardiac surgery (2) Cefuroxime is superior to Cafazolin as a prophylactic antibiotic in adult cardiac surgery. Secondary endpoints include; organisms causing surgical site infections, length of hospital and ICU stay, and worsening in renal function.
- Conditions
- Surgical Site Infection
- Being tested
- Cefuroxime, Cefazolin, 24 hours, 48 hours
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefuroximeDrug
second generation cephalosporin
CefazolinDrug
First generation cephalosporin
24 hoursOther
Duration of antibiotic therapy
48 hoursOther
Duration of antibiotic therapy
| Study group | Role | What they receive |
|---|---|---|
| 24 hour Cefuroxime arm | Active comparator | 25% of the entire study participants are assigned to 24 hours and second generation cephalosporin Receives: Drug: Cefuroxime; Other: 24 hours |
| 24 hour Cefazolin arm | Active comparator | 25% of the entire study participants are assigned to 24 hours and first generation cephalosporin Receives: Drug: Cefazolin; Other: 24 hours |
| 48 hour Cefuroxime arm | Active comparator | 25% of the entire study participants are assigned to 48 hours and second generation cephalosporin Receives: Drug: Cefuroxime; Other: 48 hours |
| 48 hour Cefazolin arm | Active comparator | 25% of the entire study participants are assigned to 48 hours and first generation cephalosporin Receives: Drug: Cefazolin; Other: 48 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical site infection rate is less with Cefuroxime than Cefazolin
that Second Generation Cefalosporin is superior to first generation
Measured: within 3 months from date of surgery
surgical site infection rate is less with 48 hours rather than 24 hours
That Longer duration of prophylaxis is better than shorter duration
Measured: within 3 months from date of surgery
Secondary outcomes (4)
Length of actual Hospital Stay in the group assigned to 48 hours of cefuroxime
that 48 hours of cefuroxime will reduce hospital stay
Measured: within 3 months from date of surgery
Length of ICU Stay will be shorter in the group assigned to 48 hours of cefuroxime
that 48 hours of cefuroxime will reduce ICU stay
Measured: within 3 months from date of surgery
rate of infection with a specific organism following each of the antibiotics used
type of organism following each type of antibiotic used
Measured: within 3 months from date of surgery
change from baseline of serum creatinine for each antibiotic used
that 48 hours of cefuroxime will not worsen renal function
Measured: within 3 months from date of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start6 Feb 2018
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 50% of study patients will be assigned to first generation cephalosporin while the other 50% will be assigned to the second generation cephalosporin. 50% of the entire study participants will be assigned to 24 hour therapy while the other 50% will be assigned to 48 hours
- Masking
- None (open label)
- Enrolment
- 568 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saud Al Babtain Cardiac Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mohammed S Koudieh, MD, Principal investigator, Saud AlBabtain Cardiac CenterShukri M AlSaif, MD, Principal investigator, Saud AlBabtain Cardiac Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303390
- Sponsor's protocol ID
- SBCC-2017-14
- Status last verified
- Apr 2023
- First submitted
- 3 Nov 2019
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 24 Versus 48 Hours of First Generation or Second Generation Cephalosporin as Prophylaxis to Reduce Surgical Site Infection in Adult Cardiac Surgery Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04303390
- Acronym / sponsor ID
- SBCC-2017-14
- Conditions
- Surgical Site Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 568 participants (actual)
- Lead sponsor
- Saud Al Babtain Cardiac CenterOther government
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized control trial studying the effect of prophylactic antibiotics to reduce surgical site infections following cardiac surgery in adults using 1st generation cephalosporin (Cefazolin) or 2nd generation cephalosporin (Cefuroxime).
Detailed description
A prospective randomized controlled patient blinded study with 2x2 factional design. It aims to study optimal duration of antibiotic to reduce surgical site infections following cardiac surgery in adults 24 or 48 hours using 1st generation cephalosporin (Cefazolin) or 2nd generation cephalosporin (Cefuroxime). Patients shall remain on either medicines for 24 or 48 hours. The primary endpoints of the study are:(1) 48 hours antibiotic prophylaxis is superior to 24 hours in adult cardiac surgery (2) Cefuroxime is superior to Cafazolin as a prophylactic antibiotic in adult cardiac surgery. Secondary endpoints include; organisms causing surgical site infections, length of hospital and ICU stay, and worsening in renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 50% of study patients will be assigned to first generation cephalosporin while the other 50% will be assigned to the second generation cephalosporin. 50% of the entire study participants will be assigned to 24 hour therapy while the other 50% will be assigned to 48 hours
| Arm | Type | Receives |
|---|---|---|
| 24 hour Cefuroxime arm | Active comparator | Drug: Cefuroxime, Other: 24 hours25% of the entire study participants are assigned to 24 hours and second generation cephalosporin |
| 24 hour Cefazolin arm | Active comparator | Drug: Cefazolin, Other: 24 hours25% of the entire study participants are assigned to 24 hours and first generation cephalosporin |
| 48 hour Cefuroxime arm | Active comparator | Drug: Cefuroxime, Other: 48 hours25% of the entire study participants are assigned to 48 hours and second generation cephalosporin |
| 48 hour Cefazolin arm | Active comparator | Drug: Cefazolin, Other: 48 hours25% of the entire study participants are assigned to 48 hours and first generation cephalosporin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ability to provide informed consent
- Planned to undergo a cardiac surgical procedure
Key exclusion criteria (6 listed)
- Patients on antibiotics on the day of surgery or those who received any within 7 days for any reason
- Patients taken to operating room as salvage
- Patients who are allergic to either cefuroxime or cefazolin
- Patients for LVAD or ECMO
- Patients who are known MRSA carriers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cefuroximesecond generation cephalosporin | Drug | 24 hour Cefuroxime arm, 48 hour Cefuroxime arm |
| CefazolinFirst generation cephalosporin | Drug | 24 hour Cefazolin arm, 48 hour Cefazolin arm |
| 24 hoursDuration of antibiotic therapy | Other | 24 hour Cefazolin arm, 24 hour Cefuroxime arm |
| 48 hoursDuration of antibiotic therapy | Other | 48 hour Cefazolin arm, 48 hour Cefuroxime arm |
Primary outcome
surgical site infection rate is less with Cefuroxime than Cefazolin
Time frame: within 3 months from date of surgery
that Second Generation Cefalosporin is superior to first generation
surgical site infection rate is less with 48 hours rather than 24 hours
Time frame: within 3 months from date of surgery
That Longer duration of prophylaxis is better than shorter duration
4 secondary outcomes
Length of actual Hospital Stay in the group assigned to 48 hours of cefuroxime
Time frame: within 3 months from date of surgery
Length of ICU Stay will be shorter in the group assigned to 48 hours of cefuroxime
Time frame: within 3 months from date of surgery
rate of infection with a specific organism following each of the antibiotics used
Time frame: within 3 months from date of surgery
change from baseline of serum creatinine for each antibiotic used
Time frame: within 3 months from date of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed S Koudieh, MD principal investigator
Saud AlBabtain Cardiac Center
Shukri M AlSaif, MD principal investigator
Saud AlBabtain Cardiac Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefuroxime, Cefazolin and 24 hours in people with Surgical Site Infection, run by Saud Al Babtain Cardiac Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical site infection rate is less with Cefuroxime than Cefazolin (time frame: within 3 months from date of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.