Trials Sponsors Conditions Drugs Pricing

Brief Summary

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

Keywords

Mandible fracturesAntibioticsOpen Reduction and Internal FixationCo-amoxiclavAntibiotic ResistanceSurgical Site Infection

Outcome Measures

Primary Outcomes (1)

Surgical Site Infection
Incidence of Surgical Site Infection (CDC definition) following surgery for mandible fractures
30 days

Secondary Outcomes (11)

Return to theatre within 30 days
30 days
Length of hospital stay
14 days, 30 days, 180 days
Death and cause of death
14 days, 30 days, 180 days
Hospital readmission
30 days
Malunion: fracture non-healing
180 days
+6 more secondary outcomes

Study Arms (3)

Group A

EXPERIMENTAL

Group A: One induction IV dose

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

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

Interventions

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).

Group AGroup BGroup C

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ability to provide written informed consent
Age≥18 years

Sponsors & Collaborators

East Lancashire Hospitals NHS Trust
Otherlead

Study Sites (2)

East Lancashire Hospitals NHS Trust

Blackburn, Lancashire, BB2 3HH, United Kingdom

RECRUITING

Panayiotis KyzasCONTACT07505402640 Panayiotis.Kyzas@elht.nhs.uk

East Lancashire Hospitals NHS Trust

Blackburn, Lancashire, BB2 3HH, United Kingdom

NOT_YET_RECRUITING

Panayiotis KyzasCONTACT07505402640

MeSH Terms

Conditions

Mandibular FracturesSurgical Wound Infection

Condition Hierarchy (Ancestors)

Jaw FracturesMaxillofacial InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesSkull FracturesFractures, BoneWounds and InjuriesWound InfectionInfectionsPostoperative ComplicationsPathologic Processes

Study Officials

Panayiotis Kyzas, PhD
Consultant OMFS H&N Surgeon ELHT
PRINCIPAL INVESTIGATOR

Central Study Contacts

Panayiotis Kyzas

CONTACT

+447505402640 Panayiotis.Kyzas@elht.nhs.uk

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 11, 2023

First Posted

July 27, 2023

Study Start

December 6, 2024

Actual (reported)

Primary Completion

June 30, 2027

Estimated

The MANTRA Trial (MANdibular TRauma and Antibiotic Use)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (3)

Group A

Group B

Group C

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

The MANTRA Trial (MANdibular TRauma and Antibiotic Use)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (3)

Group A

Group B

Group C

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations