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21/587 Should we prescribe postoperative antibiotics to patients with facial fracture? commissioning brief

Contents

Introduction

The aim of the HTA Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests is produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.

Research question

Should we prescribe postoperative antibiotics to patients with facial fracture?

  1. Intervention: Postoperative antibiotic treatment (Applicants to specify and justify their choice of post-operative drug/s and regimen). 
  2. Patient group: Patients with facial fracture(s) who are having surgery (Applicants to specify and justify).   Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
  3. Setting: Secondary care. 
  4. Control: No postoperative antibiotics.          
  5. Study design: A randomised controlled trial with an internal pilot phase to test key trial processes such as recruitment and adherence. Clear stop/go criteria should be provided to inform progression from pilot to full trial.
  6. Important outcomes: Return to theatre (e.g. wound complications); infection; revision surgery.  Other outcomes: Adverse events, including (but not limited to) antibiotic-related adverse events; antibiotic usage; patient and clinician acceptability. Subgroup analyses should be considered as appropriate (e.g. by fracture type, type of surgery; confounding factors, etc.). Applicants should specify and justify their approach to masking, e.g. in the assessment of patient outcomes. Existing Core Outcomes should be included amongst the list of outcomes unless a good rationale is provided to do otherwise.
  7. Minimum duration of follow-up: 6 months.
  8. Longer-term follow up: If appropriate, researchers should consider obtaining consent to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study.

Rationale

Every year, in the UK, several thousand patients require surgery for facial fractures, usually caused by accidents, falls, or assault. Infection of the surgical site is of great concern, as this may lead to impaired repair and post-operative complications.

While there is consensus over the pre-operative use of one prophylactic dose of antibiotic in higher-risk fractures (e.g. mandibular or maxillary fractures because of their exposure to the oral cavity and flora), opinions differ about the post-operative antimicrobial cover for these patients, and there is great variation in the use of post-operative antibiotics across the UK. Currently, three different approaches are in use: (i) Antibiotics at induction only; (ii) Antibiotics at induction and post-operative intravenous doses whilst an inpatient; (iii) Antibiotics at induction, post-operative intravenous doses, followed by a 5-7 day oral course.

Observational studies and expert opinion suggest no significant difference exists in the rate of post-operative complications, regardless of which antibiotic regimen was used. There is concern among surgeons about potential overuse of antibiotics and potential contribution to antibiotic resistance.

To date, no sufficiently powered randomised study was undertaken to explore the effectiveness of pre-operative antibiotics only, compared with an antibiotic regimen that includes both pre- and post-operative antibiotics.

The HTA programme wishes to fund the study outlined above to inform clinical practice and future guidance, and to potentially reduce the use of antibiotics in this patient group.

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the funding opportunities page. To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted on-line no later than 1pm on the 30 March 2022. Applications will be considered by the HTA Funding Committee at its meeting in May 2022.

Guidance notes and supporting information for HTA Programme applications are available.

Important: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in September 2022.

Applications received electronically after 1300 hours on the due date will not be considered.

For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition.

For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared.

Should you have any queries please contact us by email: htacommissioning@nihr.ac.uk