Continuous Infusion Versus Intermittent IV Bolus of Cefazolin: Prevention of Surgical Site Infection During CABG Surgeries in Egyptian Patients.
A randomized controlled trial on adults who underwent coronary artery bypass grafting (CABG) surgery. To evaluate the effectiveness of intraoperative continuous infusion (CI) of cefazolin compared with intermittent (INT) cefazolin administration in preventing surgical site infection in the CABG population.
Eligible patients will be randomized using a block design into 2 groups: intervention and control. The intervention group will use continuous infusion of cefazolin (CI), while the control group will follow the traditional presurgical prophylaxis protocol of intermittent cefazolin doses (INT).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Heba A Abdeen
- Phone Number: 0201003403231
- Email: hebabdeen89@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Cardiothoracic ICU-admitted patients who underwent CABG on CPB.
Exclusion Criteria:
- Patients who require reoperation within 30 days.
- Immunosuppressant patients.
- Patients who are not adherent to the protocol time or dosing, either preoperatively, during, or postoperatively.
- Pregnancy or breastfeeding.
- Patients who refused to sign the informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intraoperative continuous infusion (CI) of cefazolin
|
To evaluate the effectiveness of intraoperative continuous infusion (CI) of cefazolin compared with intermittent (INT) cefazolin administration in preventing SSIs in a CABG (coronary artery bypass grafting) population.
|
|
Active Comparator: Intermittent (INT) cefazolin
|
To evaluate the effectiveness of intermittent (INT) cefazolin administration in preventing SSIs in a CABG (coronary artery bypass grafting) population.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of SSI
Time Frame: Within 3 months after surgery
|
Within 3 months after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Postoperative Complications
- Pathologic Processes
- Infections
- Wound Infection
- Pathological Conditions, Signs and Symptoms
- Surgical Wound Infection
- Sulfur Compounds
- Organic Chemicals
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Amides
- beta-Lactams
- Lactams
- Cephalosporins
- Thiazines
- Cefazolin
Other Study ID Numbers
- 08112025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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