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Antibiotics for Preventing Surgical Infections

Phase 4
Recruiting
Research Sponsored by Abdul El-Rabbany
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* All patients ASA 1 and 2 over the age of 16 undergoing orthognathic surgery will be offered participation in this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial focuses on orthognathic surgery, which is a group of procedures to fix jaw and facial deformities. The surgeries aim to improve speech, jaw function, aesthetics, and sleep apnea

Who is the study for?
This trial is for patients over the age of 16 who are healthy or have mild systemic disease (ASA 1 and 2) and are scheduled for orthognathic surgery to correct jaw deformities. It aims to determine if additional post-operative antibiotics reduce infection risk without contributing significantly to antibiotic resistance.
What is being tested?
The study compares two groups: Group A receives a single pre-operative dose of cefazolin, while Group B gets the same plus three more doses after surgery. The goal is to see if more antibiotics post-surgery prevent infections better than just one dose before surgery.
What are the potential side effects?
Possible side effects from cefazolin may include allergic reactions, toxicity, or other medication-related issues. These will be monitored along with any surgical complications that could relate to infection risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Surgical Site Infection Rate
Secondary study objectives
Impact of medication adverse effects on surgical site infection rate
Impact of sex on surgical site infection rate
Impact of smoking status on surgical site infection rate
+4 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Single DoseExperimental Treatment1 Intervention
Single pre-operative dose of 2g IV Cefazolin given prior to first incision for orthognathic surgical procedure
Group II: 24-Hour DosingActive Control1 Intervention
Single pre-operative dose of 2g IV Cefazolin given prior to first incision for orthognathic surgical procedure, as well as 2g IV Cefazolin q8h post-operatively for 24 hours (3 total doses)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cefazolin 2 GM Injection
2013
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Abdul El-RabbanyLead Sponsor
~262 spots leftby Jul 2026
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