Should we prescribe postoperative antibiotics to patients with mandibular fractures?

Title  Should we prescribe postoperative antibiotics to patients with mandibular fractures?
Acronym  SAM
Study Type Clinical Trial
Status  In development
Funding  TBC
Ethics TBC

NFORC has collaborated with Oral and Maxillofacial surgeons and Barts Clinical Trial Unit to design a study in response to a National Institute for Health and Care Research (NIHR) commissioned funding opportunity. The funding opportunity wants researchers to investigate the use of postoperative antibiotics in patients with facial fractures.

The study proposal has been submitted to NIHR and we are now awaiting the result of being shortlisted to the next stage of the application process.


Background

10,000 people a year suffer fractured mandibles (jaws). About 7% get postoperative infections requiring further treatment with antibiotics. Some require operations to correct complications that are associated with their infections resulting in:
a) cost to the NHS
b) morbidity to the patient
c) economic loss to the patient

The prescription of antibiotics may be central to these issues. There is neither consensus nor evidence to suggest a protocol which is of most benefit to the patient.

The proposed study is a double-blinded placebo-controlled cluster randomised study into the effectiveness of postoperative antibiotics in patients with mandibular fractures.

Aims and objections

  • To determine whether the omission of post-operative antibiotics in patients who have had surgery for mandibular fractures results in a clinically significant increase in infections that require further treatment.
  • To determine how fracture, medical and socio-economic factors affect infection and return-to-theatre rates.
  • To determine whether there is a difference in quality of life between patients who receive post-operative antibiotics and patients who receive placebo.

Who manages the trial?

Chief Investigator
Professor Simon Holmes

Co-lead investigator 
Mr Douglas Hammond

NFORC Director
Prof Iain Hutchison

Barts Clinical Trial Unit Director
Professor Rhian Gabe

Saving Faces Clinical Research Manager
Fran Ridout

The project will be co-ordinated by Barts Clinical Trial Unit and the National Facial and Oral Research Centre (NFORC), a branch of Saving Faces.

For further information, please contact NFORC
Email: info@nforc.co.uk