Mandible FracturePhase 3MANTRANCT05964140
The MANTRA Trial (MANdibular TRauma and Antibiotic Use)
A Phase 3 study testing Different post-operative antibiotic regimens following surgical treatment of mandible fractures in people with Mandible Fracture and Post-operative Antibiotics, run by East Lancashire Hospitals NHS Trust at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandible Fracture, Post-operative Antibiotics
- What is being tested?
- Different post-operative antibiotic regimens following surgical treatment of mandible fractures
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,841 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 6 Dec 2024to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide written informed consent
- Age≥18 years
- Hospital episode of mandible fracture(s)
- Planned treatment is surgery - (ORIF with titanium miniplates)
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
East Lancashire Hospitals NHS Trust
Blackburn, Lancashire, BB2 3HH
Panayiotis Kyzas, 07505402640, Panayiotis.Kyzas@elht.nhs.uk
- Not yet recruiting
East Lancashire Hospitals NHS Trust
Blackburn, Lancashire, BB2 3HH
Panayiotis Kyzas, 07505402640, Panayiotis.Kyzas@elht.nhs.uk
About this study
Official title: Should we Use Post-operative Antibiotics Following Surgery for Patients With Mandible Fractures? The MANTRA Trial (MANdibular TRauma and Antibiotic Use)
- 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)
- 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 risk of infection. Previous systematic reviews and a multicentre cohort study performed by this team, revealed significant clinical variation in post-operative antibiotic prescription amongst UK OMFS clinicians and the presence of clinical equipoise. Antibiotic overuse can lead to antibiotic resistance and other antibiotic-related side effects; judicious antibiotic use and stewardship is of paramount importance.
Aim: To determine whether post-operative antibiotics are required at all, following surgery for mandible fractures, and, if so, what is the most clinically- and cost-effective regimen
Read more
Objectives:
Primary Objective To conduct a Randomized Controlled Trial (MANTRA) in order to establish the non-inferiority (or not) of not giving post-operative antibiotics versus 2 other post-operative antibiotic regimens. An internal pilot phase will optimise recruitment and retention.
Secondary Objectives
- Measure the cost-effectiveness of the proposed antibiotic pathways
- Assess patient and clinician acceptability to change clinical practice
- Process evaluation to inform dissemination and implementation Methods: The investigators designed and propose the MANTRA RCT to compare 3 post-operative antibiotic approaches to prevent Surgical Site Infections (SSIs) following surgery for mandible fractures. The MANTRA trial is a large open label, multicentre study in NHS OMFS units. The 3 study arms represent the most common clinical pathways in the UK based on previous work; the control group is the approach prescribed by most UK OMFS clinicians. All patients will receive 1 dose of IV antibiotics (co-amoxiclav 1.2g, if no penicillin allergy, which is the most commonly used prophylactic antibiotic currently) on induction of anaesthesia, prior to their surgery.
The participants will be randomised to the following (1:1:1):
Group A: No further antibiotics Group B: 2 further postoperative IV doses of co-amoxiclav 1.2g Group C: 2 further postoperative IV doses (as above), followed by a 5-day course of oral co-amoxiclav 625mg every 8 hours if no penicillin allergy (Control).
Trial processes will be optimised by an internal pilot phase ensuring we recruit, randomise, and retain participants with clear progression criteria. We will also conduct cost-effectiveness analyses and process evaluation for dissemination and implementation
Timeline:
Start of grant: 1st July 2023 Start of RCT / pilot: 1st January 2024 End of pilot: 30th June 2024 End of recruitment: 31st December 2026 End of follow-up: 30th June 2027 Completion: 31st December 2027
Impact and dissemination:
- Practice changing outputs that standardise the use of antibiotics in mandible fractures in the NHS and provide a framework for other surgical prophylaxis research
- A bespoke clinical dissemination plan via an engagement and training legacy
- Cost-effectiveness data to inform policy making
- A research legacy and change of culture in the specialty of OMFS
- Conditions
- Mandible Fracture, Post-operative Antibiotics
- Being tested
- Different post-operative antibiotic regimens following surgical treatment of mandible fractures
- Keywords
- Mandible fractures, Antibiotics, Open Reduction and Internal Fixation, Co-amoxiclav, Antibiotic Resistance, Surgical Site Infection
- Medical subject headings
- Mandibular Fractures, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different post-operative antibiotic regimens following surgical treatment of mandible fracturesDrug
The 3 study arms represent the most common antibiotic regimens used in current clinical practice following surgery for mandible fractures. The control group is the most common approach.
All patients will receive 1 dose of IV antibiotics (co-amoxiclav 1.2g), if no penicillin allergy, on induction of anaesthesia, prior to their surgery.
The participants will be randomised to the following (1:1:1):
Group A: No further antibiotics Group B: 2 further postoperative IV doses of co-amoxiclav 1.2g Group C: 2 further postoperative IV doses (as above), followed by a 5-day course of oral co-amoxiclav 625mg every 8 hours if no penicillin allergy (Control).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A: One induction IV dose Receives: Drug: Different post-operative antibiotic regimens following surgical treatment of mandible fractures |
| Group B | Experimental | Group B: One induction IV dose and 2 further postoperative IV doses Receives: Drug: Different post-operative antibiotic regimens following surgical treatment of mandible fractures |
| Group C | Active comparator | Group C: One IV dose of antibiotics on induction and 2 further postoperative IV doses (as above), followed by a 5-day course of oral co-amoxiclav 625mg every 8 hours if no penicillin allergy Receives: Drug: Different post-operative antibiotic regimens following surgical treatment of mandible fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection
Incidence of Surgical Site Infection (CDC definition) following surgery for mandible fractures
Measured: 30 days
Secondary outcomes (11)
Return to theatre within 30 days
Measured: 30 days
Length of hospital stay
Measured: 14 days, 30 days, 180 days
Death and cause of death
Measured: 14 days, 30 days, 180 days
Hospital readmission
Measured: 30 days
Malunion: fracture non-healing
Fibrous union, fracture mobility, absence of callus formation
Measured: 180 days
Malocclusion: teeth not meeting as they should
When the fracture reduction failed to restore the dental occlusion
Measured: 180 days
Metalwork removal
When the fixation titanium miniplates need to be removed at any point and for any reason
Measured: 14 days, 30 days, 180 days
Overall antibiotic exposure
Measured: 14 days, 30 days, 180 days
Antibiotic related adverse events/serious adverse events
Measured: 14 days, 30 days, 180 days
Cost
Measured: 14 days, 30 days, 180 days
HRQoL (EQ-5D-5L)
Health Related Quality of Life
Measured: 14 days, 30 days, 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start6 Dec 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandible FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Non-inferiority RCT
- Masking
- None (open label)
- Enrolment
- 2,841 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Lancashire Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Panayiotis Kyzas, PhD, Principal investigator, Consultant OMFS H&N Surgeon ELHT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964140
- Sponsor's protocol ID
- DEV008
- Acronym
- MANTRA
- Status last verified
- Jan 2026
- First submitted
- 11 Jul 2023
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should we Use Post-operative Antibiotics Following Surgery for Patients With Mandible Fractures? The MANTRA Trial (MANdibular TRauma and Antibiotic Use)
- ClinicalTrials.gov ID
- NCT05964140
- Acronym / sponsor ID
- MANTRA / DEV008
- Conditions
- Mandible Fracture, Post-operative Antibiotics
- Keywords
- Mandible fractures, Antibiotics, Open Reduction and Internal Fixation, Co-amoxiclav, Antibiotic Resistance, Surgical Site Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,841 participants (estimated)
- Lead sponsor
- East Lancashire Hospitals NHS TrustUniversity, hospital or other
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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)
- 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 risk of infection. Previous systematic reviews and a multicentre cohort study performed by this team, revealed significant clinical variation in post-operative antibiotic prescription amongst UK OMFS clinicians and the presence of clinical equipoise. Antibiotic overuse can lead to antibiotic resistance and other antibiotic-related side effects; judicious antibiotic use and stewardship is of paramount importance.
Aim: To determine whether post-operative antibiotics are required at all, following surgery for mandible fractures, and, if so, what is the most clinically- and cost-effective regimen
Objectives:
Primary Objective To conduct a Randomized Controlled Trial (MANTRA) in order to establish the non-inferiority (or not) of not giving post-operative antibiotics versus 2 other post-operative antibiotic regimens. An internal pilot phase will optimise recruitment and retention.
Secondary Objectives
- Measure the cost-effectiveness of the proposed antibiotic pathways
- Assess patient and clinician acceptability to change clinical practice
- Process evaluation to inform dissemination and implementation Methods: The investigators designed and propose the MANTRA RCT to compare 3 post-operative antibiotic approaches to prevent Surgical Site Infections (SSIs) following surgery for mandible fractures. The MANTRA trial is a large open label, multicentre study in NHS OMFS units. The 3 study arms represent the most common clinical pathways in the UK based on previous work; the control group is the approach prescribed by most UK OMFS clinicians. All patients will receive 1 dose of IV antibiotics (co-amoxiclav 1.2g, if no penicillin allergy, which is the most commonly used prophylactic antibiotic currently) on induction of anaesthesia, prior to their surgery.
The participants will be randomised to the following (1:1:1):
Group A: No further antibiotics Group B: 2 further postoperative IV doses of co-amoxiclav 1.2g Group C: 2 further postoperative IV doses (as above), followed by a 5-day course of oral co-amoxiclav 625mg every 8 hours if no penicillin allergy (Control).
Trial processes will be optimised by an internal pilot phase ensuring we recruit, randomise, and retain participants with clear progression criteria. We will also conduct cost-effectiveness analyses and process evaluation for dissemination and implementation
Timeline:
Start of grant: 1st July 2023 Start of RCT / pilot: 1st January 2024 End of pilot: 30th June 2024 End of recruitment: 31st December 2026 End of follow-up: 30th June 2027 Completion: 31st December 2027
Impact and dissemination:
- Practice changing outputs that standardise the use of antibiotics in mandible fractures in the NHS and provide a framework for other surgical prophylaxis research
- A bespoke clinical dissemination plan via an engagement and training legacy
- Cost-effectiveness data to inform policy making
- A research legacy and change of culture in the specialty of OMFS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Non-inferiority RCT
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Different post-operative antibiotic regimens following surgical treatment of mandible fracturesGroup A: One induction IV dose |
| Group B | Experimental | Drug: Different post-operative antibiotic regimens following surgical treatment of mandible fracturesGroup B: One induction IV dose and 2 further postoperative IV doses |
| Group C | Active comparator | Drug: Different post-operative antibiotic regimens following surgical treatment of mandible fracturesGroup C: One IV dose of antibiotics on induction and 2 further postoperative IV doses (as above), followed by a 5-day course of oral co-amoxiclav 625mg every 8 hours if no penicillin allergy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to provide written informed consent
- Age≥18 years
- Hospital episode of mandible fracture(s)
- Planned treatment is surgery - (ORIF with titanium miniplates)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Different post-operative antibiotic regimens following surgical treatment of mandible fracturesThe 3 study arms represent the most common antibiotic regimens used in current clinical practice following surgery for mandible fractures. The control group is the most common approach. All patients will receive 1 dose of IV antibiotics (co-amoxiclav 1.2g), if no penicillin allergy, on induction of anaesthesia, prior to their surgery. The participants will be randomised to the following (1:1:1): Group A: No further antibiotics Group B: 2 further postoperative IV doses of co-amoxiclav 1.2g Group C: 2 further postoperative IV doses (as above), followed by a 5-day course of oral co-amoxiclav 625mg every 8 hours if no penicillin allergy (Control). | Drug | Group A, Group B, Group C |
Primary outcome
Surgical Site Infection
Time frame: 30 days
Incidence of Surgical Site Infection (CDC definition) following surgery for mandible fractures
11 secondary outcomes
Return to theatre within 30 days
Time frame: 30 days
Length of hospital stay
Time frame: 14 days, 30 days, 180 days
Death and cause of death
Time frame: 14 days, 30 days, 180 days
Hospital readmission
Time frame: 30 days
Malunion: fracture non-healing
Time frame: 180 days
Malocclusion: teeth not meeting as they should
Time frame: 180 days
Metalwork removal
Time frame: 14 days, 30 days, 180 days
Overall antibiotic exposure
Time frame: 14 days, 30 days, 180 days
Antibiotic related adverse events/serious adverse events
Time frame: 14 days, 30 days, 180 days
Cost
Time frame: 14 days, 30 days, 180 days
HRQoL (EQ-5D-5L)
Time frame: 14 days, 30 days, 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Panayiotis Kyzas, PhD principal investigator
Consultant OMFS H&N Surgeon ELHT
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Different post-operative antibiotic regimens following surgical treatment of mandible fractures in people with Mandible Fracture and Post-operative Antibiotics, run by East Lancashire Hospitals NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Panayiotis Kyzas (+447505402640, Panayiotis.Kyzas@elht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.