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The MANTRA Trial (MANdibular TRauma and Antibiotic Use)

RecruitingPhase 3Ages 18 Years - anyAllEast Lancashire Hospitals NHS Trust
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In plain words

What the trial is, and whether it could suit you

1. FULL TITLE OF THE PROJECT Should we use post-operative antibiotics following surgery for patients with mandible fractures? The MANTRA trial (MANdibular TRauma and Antibiotic use) 2. SUMMARY OF RESEARCH (ABSTRACT) Research Question: Are post-operative antibiotics required following surgery for patients with mandible fractures? Background: Mandible fractures are the commonest facial fractures needing surgery and account for a significant percentage of the acute workload in Oral \& Maxillofacial Surgery (OMFS) units. The UK records over 6000 new cases per year. Patients having surgery for mandible fractures have a theoretical risk of developing surgical site infection, due to the proximity of the fracture lines to the oral cavity microbes and the presence of foreign body (titanium fixation miniplates). For this reason, clinicians often prescribe antibiotics after surgery, to reduce the r

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๐Ÿ“‹ Eligibility rules (as published)
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 * Ageโ‰ฅ18 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)
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What it tests

  • Different post-operative antibiotic regimens following surgical treatment of mandible fractures
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Where

2 sites
East Lancashire Hospitals NHS Trust
Blackburn, United Kingdom
East Lancashire Hospitals NHS Trust
Blackburn, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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