Evaluating the need for antibiotics after mandible fracture surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: Panayiotis.Kyzas@elht.nhs.uk
• Phone: +447505402640

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.