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