- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07655596
Continuous Infusion Versus Intermittent IV Bolus of Cefazolin: Prevention of Surgical Site Infection During Orthopedic Surgeries in Egyptian Patients.
A randomozed control trial on adults who underwent orthopaedic surgery. To evaluate the effectiveness of intraoperative continuous infusion (CI) of cefazolin compared with intermittent (INT) cefazolin administration in preventing SSIs in the orthopaedic surgical population.
Eligible patients will be randomized using block randomization into 2 groups: intervention group and control group. 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:
- Orthopaedic surgical ward patients who underwent major surgery.
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.
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: Continuous infusion of cefazolin
|
Intraoperative continuous infusion (CI) of cefazolin
|
|
Active Comparator: Intermittent cefazolin injection
|
Administration of cefazolin 2 gm 30 minutes pre-surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of surgical site infection
Time Frame: within 90 days after surgery.
|
To evaluate the effectiveness of intraoperative continuous infusion (CI) of cefazolin compared with intermittent (INT) cefazolin administration in preventing SSIs in the orthopedic surgical population.
|
within 90 days 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
- 1803062025
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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