Antibiotics for Prevention of Infection Following Orthognathic Surgery

NCT05852158 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 1028749
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Orthognathic surgery describes a group of procedures aimed at correcting developmental or acquired deformities of the jaws and facial skeleton. The goal of these procedures is to improve speech, jaw and dental function, aesthetics, and symptoms of sleep apnea. This is accomplished by surgical repositioning of the upper jaw (maxilla) and lower jaw (mandible). The most common procedures are lefort I osteotomies (upper jaw repositioning) and bilateral sagittal split osteotomies (lower jaw repositioning). At our institution, almost all cases include one or both of these two procedures. The majority of cases include bilateral sagittal split osteotomies (BSSO). As access to the jaws is through the oral cavity, these procedures are considered to be clean-contaminated surgeries due to the high intra-oral bacterial load. The result is that surgical site infections (SSIs) occur in 10-15% of cases. Studies show that the vast majority of these infections occur in the lower jaw (BSSO sites), presumably due to pooling of saliva and debris. SSIs are associated with patient discomfort, prolonged hospital stays, increased morbidity, and increased cost to healthcare systems. The use of peri-operative antibiotics has been shown to significantly reduce the incidence of SSI following orthognathic surgery. There is currently no consensus on the dosing or specific antibiotic to be used. There is strong evidence that pre-operative antibiotics significantly decrease SSI compared to no antibiotics. However, to date, there is no good evidence to support the use of post-operative antibiotics to further decrease the rate of infection. Several studies have examined the use of post-operative antibiotics ranging between 1-7 days. The majority of studies were not able to demonstrate a statistically significant difference to justify the use of post-operative antibiotics. A systematic review by Danda and Ravi in 2011 suggested that there likely is a benefit to the use of post-operative antibiotics. Danda and colleagues in 2017 later conducted a trial comparing pre-operative antibiotics alone compared to pre-operative combined with post-operative antibiotics. A statistically significant difference was not found, however, they felt that this was due to a limited sample size. Overall, there is no robust data that supports the use of post-operative antibiotics. The World Health Organization guidelines currently recommend against the use of post-operative antibiotics in orthognathic surgery. However, they do comment that there is some weak evidence that suggests its use. It was deemed that this low quality evidence did not outweigh the potential harm of antimicrobial resistance, which results from inappropriate overuse of antibiotics. Antimicrobial resistance is a serious, growing problem which has deadly consequences. Our current protocol at the QEII Health Sciences Center for peri-operative antibiotic administration is a single pre-operative dose of 2g cefazolin IV, followed by further doses every 8 hours post-operatively for a total of 24 hours (3 post-operative doses). Our study aims to investigate whether there is a need for these additional post-operative doses. If there is a benefit to these additional doses, the research team aims to investigate whether this benefit outweighs the risks. This question is of great importance in order to avoid an unnecessary contribution to antibiotic resistance and unnecessary potential adverse effects. Participants will be assigned a study number and randomly allocated to one of two groups. Group A will receive a single pre-operative dose of 2g IV cefazolin. Group B will receive a pre-operative dose of 2g IV cefazolin, followed by an additional three doses post-operatively every 8 hours for a total of 24 hours. Informed consent will be obtained at each participant's pre-operative assessment in the days leading up to the procedure. The participant will then select a group designation from a sufficiently mixed jar, and group A or B will be assigned to their study number. For each patient, completed procedures will be documented, along with age, sex, smoking status, length of procedures, and complications. Complications including medication adverse reaction (allergy, toxicity, side effects), surgical complications, and any other significant complications related to the medications or deemed to be relevant to infection risk will be documented. Procedures will be carried out in the standard fashion. Patients will receive the same post-operative instructions and will be discharged with a chlorhexidine mouth rinse to be used for two weeks. Patients will return for follow-up at 2 weeks, 4 weeks, and 6 weeks post-operatively. Surgical site infection diagnosis will be made according to the CDC criteria and will be reported as either superficial, deep, or organ/space infections. Date of occurrence, location of infection, and treatment provided will be recorded on a standard form provided to surgeons.

Conditions

Orthognathic Surgical Site Infection

Keywords

Orthognathic Surgery; Surgical Site Infection; Peri-Operative Antibiotics; Post-Operative Antibiotics; Pre-Operative Antibiotics; Antibiotic Prophylaxis; Cefazolin

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection Rate

  Patients will be evaluated at 2, 4, and 6 weeks post-surgery. Surgical sites will be evaluated for presence of infection. Infections will be classified as superficial, deep, or space infection. This information, along with the location of the infection, will be recorded on a standardized form provided to surgeons. Presence of infection will be reported as "yes" or "no". Type of infection will be reported as "superficial", "deep" or "space". Location will be reported as "right maxilla", "left maxilla", "right mandible", or "left mandible".

  6 weeks

Secondary Outcomes (7)

• Rate of Medication Adverse Effects

  6 weeks

• Impact of sex on surgical site infection rate

  6 weeks

• Impact of smoking status on surgical site infection rate

  6 weeks

• Impact of surgery type on surgical site infection rate

  6 weeks

• Impact of surgical complications on surgical site infection rate

  6 weeks

Study Arms (2)

Single Dose

EXPERIMENTAL

Single pre-operative dose of 2g IV Cefazolin given prior to first incision for orthognathic surgical procedure

Drug: Cefazolin 2 GM Injection

24-Hour Dosing

ACTIVE COMPARATOR

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)

Drug: Cefazolin Injection

Interventions

Cefazolin 2 GM Injection DRUG

Single pre-op dose of 2g IV cefazolin

Also known as: Single Dose IV Cefazolin

Single Dose

Cefazolin Injection DRUG

Pre-op dose of 2g IV cefazolin along with 3 post-op doses of 2g IV cefazolin every 8 hours

Also known as: Four Doses IV Cefazolin

24-Hour Dosing

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients ASA 1 and 2 over the age of 16 undergoing orthognathic surgery will be offered participation in this study

You may not qualify if:

• Patients ASA 3 and higher, use of antibiotics in the preceding 2 weeks, presence of systemic, oral, or odontogenic infections, patients in a state of immunosuppression as a result of medications or systemic disease, patients with allergies to penicillins or cephalosporins, and patients who lack capacity for informed consent.

Sponsors & Collaborators

• Abdul El-Rabbany: lead

Study Sites (1)

Victoria General Hospital

Halifax, Nova Scotia, B3H2Y9, Canada

RECRUITING

Related Publications (31)

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  BACKGROUND

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

Abdul El-Rabbany, DMD, BSc

CONTACT

1-902-473-2070; abdul.elrabbany@dal.ca

Curtis Gregoire, MD, DDS, MSc

CONTACT

1-902-473-2070; cgregoire@dal.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Surgeons assessing for the presence of surgical site infection will be blinded to the antibiotic regimen that the patient received.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Oral and Maxillofacial Surgery Resident

Model Details: Our plan is to conduct a prospective, randomized controlled trial evaluating patients undergoing orthognathic surgery including bilateral sagittal split osteotomies with or without concomitant maxillary and/or chin surgery, with or without wisdom teeth extraction. All patients meeting the inclusion criteria will be offered participation, and informed consent will be obtained at the pre-operative appointment following surgical consent. The patients will then be assigned a study number and randomly allocated to one of two groups as follows: A) Single pre-operative dose of 2g IV Cefazolin B) Single pre-operative dose of 2g IV Cefazolin followed by a 24-hour course of 2g IV Cefazolin every 8 hours All patients will receive the same post-operative instructions and will be discharged with 0.12% chlorhexidine mouth rinse to be used for 2 weeks following discharge. Patients will return for follow-up at 2 weeks, 4 weeks, and 6 weeks following discharge.

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 10, 2023
• Study Start: January 9, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)