MANTRA

• Research type

  Research Study

• Full title

  Should we use post-operative antibiotics following surgery for patients with mandible fractures? The MANTRA trial (MANdibular TRauma and Antibiotic use)

• IRAS ID

  338889

• Contact name

  Panayiotis Kyzas

• Contact email

  Panayiotis.Kyzas@elht.nhs.uk

• Sponsor organisation

  East Lancashire Hospitals NHS Trust

• Clinicaltrials.gov Identifier

  NCT05964140

• Duration of Study in the UK

  3 years, 7 months, 31 days

• Research summary

  CONTEXT
  Mandible fractures often need fixing with surgery. This puts patients at risk of infection (10%). Infection requires treatment with antibiotics and may need further surgery. There is wide variation in antibiotic use in these cases. Some surgeons give no antibiotics after surgery, others give few intravenous doses, and others give a few intravenous doses and an additional 5-7 days of oral antibiotics.

  Currently, we do not know which antibiotic approach is best. Optimising antibiotic use is critical to reducing antibiotic-related complications and antibiotic resistance.

  STUDY AIM:
  The aim of this study is to find out if patients having surgery for a mandible fracture are less likely to get an infection if given antibiotics after their surgery. This study will compare three different postoperative antibiotic approaches and will try to answer the following questions:
  1. Does reducing antibiotics after surgery change the risk of infection?
  2. Is there any difference in cost?
  3. How do patients and health professionals feel about changing current practice?
  4. How could we best communicate the findings of the study?

  WHERE WILL THIS STUDY OPEN?
  Multiple UK NHS Oral and Maxillofacial Surgery units

  STUDY PARTICIPANTS
  Adult patients with mandible fractures requiring surgery

  HOW WILL THE TRIAL WORK?
  Participants will be assigned randomly to one of three groups:
  Group A will receive no further antibiotics after surgery
  Group B will receive 2 further doses of intravenous antibiotics after surgery
  Group C will receive 2 further doses of intravenous antibiotics AND 5 days of oral antibiotics

  Otherwise, all three patient groups will follow the normal care pathway. Patients in all 3 groups will get one dose of intravenous antibiotics just before surgery. Information about antibiotic use in the run-up to surgery and overall antibiotic exposure will be collected. Patients will be followed up at 14, 30 and 180 days after surgery.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  24/EM/0074

• Date of REC Opinion

  10 May 2024

• REC opinion

  Further Information Favourable Opinion