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Jaw surgery antibiotics under scrutiny: MANTRA trial seeks answers

NCT ID NCT05964140

Disease control Sponsor: East Lancashire Hospitals NHS Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether antibiotics are needed after surgery for a broken jaw. Many doctors prescribe them to prevent infection, but overuse can lead to antibiotic resistance. The trial will compare three approaches: no antibiotics after surgery, a short course, or a longer course, to see which works best for preventing infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 2,841 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

jaw fracture Mandibular Fractures Surgical Wound Infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mandible fracture Post-operative antibiotics

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • East Lancashire Hospitals NHS Trust

    RECRUITING

    Blackburn, Lancashire, BB2 3HH, United Kingdom

  • East Lancashire Hospitals NHS Trust

    NOT_YET_RECRUITING

    Blackburn, Lancashire, BB2 3HH, United Kingdom

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