Continuous Infusion Versus Intermittent IV Bolus of Cefazolin: Prevention of Surgical Site Infection During Orthopedic Surgeries in Egyptian Patients.

NCT07655596 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 1803062025
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

A randomized controlled trial on adults who underwent orthopedic 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. Eligible patients will be randomized in 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).

Conditions

Surgical Site Infection (SSI)

Keywords

cefazolin; orthopedic surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of surgical site infection

  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.

Study Arms (2)

Continuous infusion of cefazolin

EXPERIMENTAL

Drug: Cefazolin 2 g Infusion

Intermittent cefazolin injection

ACTIVE COMPARATOR

Drug: Cefazolin 2 GM Injection

Interventions

Cefazolin 2 g Infusion DRUG

Intraoperative continuous infusion (CI) of cefazolin

Continuous infusion of cefazolin

Cefazolin 2 GM Injection DRUG

Administration of cefazolin 2 gm 30 minutes pre-surgery

Intermittent cefazolin injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Orthopaedic surgical ward patients who underwent major surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helwan University: lead

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Heba A Abdeen

CONTACT

0201003403231; hebabdeen89@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 18, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06