Status:
RECRUITING
The MANTRA Trial (MANdibular TRauma and Antibiotic Use)
Lead Sponsor:
East Lancashire Hospitals NHS Trust
Conditions:
Mandible Fracture
Post-operative Antibiotics
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 RESE...
Eligibility Criteria
Inclusion
- 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.
- Ability to provide written informed consent
- Age≥18 years
- Hospital episode of mandible fracture(s)
- Planned treatment is surgery - (ORIF with titanium miniplates)
Exclusion
- 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)
Key Trial Info
Start Date :
December 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
2841 Patients enrolled
Trial Details
Trial ID
NCT05964140
Start Date
December 6 2024
End Date
December 31 2027
Last Update
December 12 2024
Active Locations (2)
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1
East Lancashire Hospitals NHS Trust
Blackburn, Lancashire, United Kingdom, BB2 3HH
2
East Lancashire Hospitals NHS Trust
Blackburn, Lancashire, United Kingdom, BB2 3HH