Surgical Site Infection (SSI)Phase 4NCT07655596
Continuous Infusion Versus Intermittent IV Bolus of Cefazolin: Prevention of Surgical Site Infection During Orthopedic Surgeries in Egyptian Patients.
A Phase 4 study testing Cefazolin 2 g Infusion and Cefazolin 2 GM Injection in people with Surgical Site Infection (SSI), run by Helwan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection (SSI)
- What is being tested?
- Cefazolin 2 g Infusion and Cefazolin 2 GM Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Orthopaedic surgical ward patients who underwent major surgery.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
- Being tested
- Cefazolin 2 g Infusion, Cefazolin 2 GM Injection
- Keywords
- cefazolin, orthopedic surgery
- 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.
Cefazolin 2 g InfusionDrug
Intraoperative continuous infusion (CI) of cefazolin
Cefazolin 2 GM InjectionDrug
Administration of cefazolin 2 gm 30 minutes pre-surgery
| Study group | Role | What they receive |
|---|---|---|
| Continuous infusion of cefazolin | Experimental | Not described Receives: Drug: Cefazolin 2 g Infusion |
| Intermittent cefazolin injection | Active comparator | Not described Receives: Drug: Cefazolin 2 GM Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 90 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site Infection (SSI)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebatallah Ali Abdeen, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655596
- Sponsor's protocol ID
- 1803062025
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Infusion Versus Intermittent IV Bolus of Cefazolin: Prevention of Surgical Site Infection During Orthopedic Surgeries in Egyptian Patients.
- ClinicalTrials.gov ID
- NCT07655596
- Acronym / sponsor ID
- 1803062025
- Conditions
- Surgical Site Infection (SSI)
- Keywords
- cefazolin, orthopedic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Jun 2026 (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 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous infusion of cefazolin | Experimental | Drug: Cefazolin 2 g Infusion |
| Intermittent cefazolin injection | Active comparator | Drug: Cefazolin 2 GM Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Orthopaedic surgical ward patients who underwent major surgery.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Cefazolin 2 g InfusionIntraoperative continuous infusion (CI) of cefazolin | Drug | Continuous infusion of cefazolin |
| Cefazolin 2 GM InjectionAdministration of cefazolin 2 gm 30 minutes pre-surgery | Drug | Intermittent cefazolin injection |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefazolin 2 g Infusion and Cefazolin 2 GM Injection in people with Surgical Site Infection (SSI), run by Helwan University.
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 1 inclusion and 4 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: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heba A Abdeen (0201003403231, hebabdeen89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of surgical site infection (time frame: within 90 days after surgery.). 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 24 Jun 2026.