# The MANTRA Trial (MANdibular TRauma and Antibiotic Use)

Clinical trial · East Lancashire Hospitals NHS Trust

- Archive id: nct:NCT05964140
- Published: 2023-07-27
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT05964140
- Source URL: https://clinicaltrials.gov/study/NCT05964140
- Provenance: clinicaltrials

## Abstract

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 i…

_Abstract reproduced under ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters._

## Trial details

- acronym: MANTRA
- status: RECRUITING
- phase: PHASE3
- study type: INTERVENTIONAL
- enrollment: 2841
- sponsor: East Lancashire Hospitals NHS Trust
- conditions: Mandible Fracture; Post-operative Antibiotics
- interventions: DRUG: Different post-operative antibiotic regimens following surgical treatment of mandible fractures
- start date: 2024-12-06
- start date type: ACTUAL
- primary completion date: 2027-06-30
- has results: false
- data source: ClinicalTrials.gov
- data processed: 2026-10-29T09:00:05
- modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters

Topics: [Infectious Disease, Vaccines & Antimicrobial Resistance](https://space-kitty.com/topics/infectious-disease-amr)

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