Evaluating the need for antibiotics after mandible fracture surgery

Should we Use Post-operative Antibiotics Following Surgery for Patients With Mandible Fractures? The MANTRA Trial (MANdibular TRauma and Antibiotic Use)

This study is testing if giving antibiotics after surgery for jaw fractures is really needed to help prevent infections in adults.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 2841 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: East Lancashire Hospitals NHS Trust (other)
• Locations: 2 sites (Blackburn, Lancashire and 1 other locations)
• Trial ID: NCT05964140 on ClinicalTrials.gov

What this trial studies

This trial investigates whether post-operative antibiotics are necessary for patients undergoing surgery for mandible fractures. It aims to determine the effectiveness of different antibiotic regimens in preventing surgical site infections, which are a concern due to the proximity of the oral cavity microbes to the surgical site. The study will involve adult patients who require surgical intervention for mandible fractures, with eligibility determined through emergency departments and specialized trauma clinics. The findings could help refine antibiotic use in this common surgical procedure.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and over with mandible fractures requiring surgical treatment.

Not a fit: Patients with isolated mandibular condylar fractures or existing infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could reduce unnecessary antibiotic use and associated resistance in patients undergoing mandible fracture surgery.

How similar studies have performed: Previous studies have explored antibiotic use in surgical settings, but this specific approach to mandible fractures is novel.

Eligibility criteria

All adult patients aged 18 years or over with mandible fractures requiring surgery. Most of these patients will be identified from the A\&E department via the on-call OMFS team or seen in dedicated OMFS trauma clinics. A small proportion of our study population will be seen in an OMFS clinic following referral from GP/GDP.

Inclusion Criteria:

* Ability to provide written informed consent
* Age≥18 years
* Hospital episode of mandible fracture(s)
* Planned treatment is surgery - (ORIF with titanium miniplates)

Exclusion Criteria:

* Isolated mandibular condylar fractures
* Existing fracture site infection
* Immunocompromised (transplant patients, haematological malignancies, HIV/AIDS) - a clear definition will be provided in the protocol
* Pathological fracture (e.g., malignancy, osteoradionecrosis, cysts, Medication-Related Osteonecrosis of the Jaws \[MRONJ\])
* Fractures open to skin
* Inability to provide written informed consent
* Other injuries or infections mandating ongoing post-operative antibiotics (e.g., panfacial fractures with mandible fracture component)
* Patients allergic to first and second-line antibiotic prophylaxis (as outlined above)

Where this trial is running

Blackburn, Lancashire and 1 other locations

• East Lancashire Hospitals NHS Trust — Blackburn, Lancashire, United Kingdom (RECRUITING)
• East Lancashire Hospitals NHS Trust — Blackburn, Lancashire, United Kingdom (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Panayiotis Kyzas, PhD — Consultant OMFS H&N Surgeon ELHT
• Study coordinator: Panayiotis Kyzas

Conditions: Mandible Fracture, Post-operative Antibiotics, Mandible fractures, Antibiotics, Open Reduction and Internal Fixation, Co-amoxiclav, Antibiotic Resistance, Surgical Site Infection