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New treatment option for Mandible Fracture
Official title The MANTRA Trial (MANdibular TRauma and Antibiotic Use)
ClinicalTrials.gov ID: NCT05964140
What this study is testing
What is Different post-operative antibiotic regimens following surgical treatment of mandible fractures?
Different post-operative antibiotic regimens following surgical treatment of mandible fractures is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for mandible fracture.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 1. FULL TITLE OF THE PROJECT Should we use post-operative antibiotics following surgery for patients with mandible fractures?
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All adult patients aged 18 years or over with mandible fractures requiring surgery. Most of these patients will be identified from the A\&E...
- Ability to provide written informed consent
- Age≥18 years
- Hospital episode of mandible fracture(s)
- Planned treatment is surgery - (ORIF with titanium miniplates)
You likely can't join if
- 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
See the full 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...
- Ability to provide written informed consent
- Age≥18 years
- Hospital episode of mandible fracture(s)
- Planned treatment is surgery - (ORIF with titanium miniplates)
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Blackburn, Lancashire, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Blackburn, Lancashire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.