Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964140
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2023-07-11
Brief Title:
The MANTRA Trial MANdibular TRauma and Antibiotic Use
Sponsor:
East Lancashire Hospitals NHS Trust
Organization:
East Lancashire Hospitals NHS Trust
Study Overview
Official Title:
Should we Use Post-operative Antibiotics Following Surgery for Patients With Mandible Fractures The MANTRA Trial MANdibular TRauma and Antibiotic Use
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MANTRA
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 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 12g 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 111
Group A No further antibiotics Group B 2 further postoperative IV doses of co-amoxiclav 12g 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
2 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 12g 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 111
Group A No further antibiotics Group B 2 further postoperative IV doses of co-amoxiclav 12g 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None