surgical site infections wound infections
Conditions
Interventions
Patients will be randomised to receive dexamethasone 8 mg or saline placebo,
administered intravenously within 5 minutes after induction of anaesthesia.
dexamethasone
infection
surgery
Sponsors
Alfred Health
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Adult patients *18 years of age * American Society of Anesthesiologists (ASA) physical status 1-4 * Elective or Expedited non-cardiac surgery of at least 2 hours duration under general anaesthesia (± regional block) * At least two hours* duration * Requiring a hospital stay of at least one postoperative night * A surgical skin incision > 5 cm in length or multiple incisions with a total incision length of 5 cm.
Exclusion criteria
Exclusion criteria: * Poorly controlled type 1 diabetes (HbA1c > 9.0%) * Endovascular procedure with a small (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical Site Infection at 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| PONV OUTCOMES 1. Nausea (0-24 hours)- Nausea as measured on a numerical rating scale (NRS) in the first 24 hours following surgery 2. Vomiting (0-24 hours)- Vomiting (occurrence and number of events) within first 24hours following surgery PAIN OUTCOMES 3. Highest pain score (NRS) at rest and on movement in the first 24 hours 4. Chronic Post-Surgical Pain (at 6 months)- defined as pain over the surgical site, for at least three months after surgery, that cannot be explained by other causes, such as disease recurrence or a pre-existing pain syndrome. OTHER OUTCOMES 5. Hospital stay: from the start (date, time) of surgery until actual hospital discharge. 6. Quality of recovery: QoR-15 score on days 1, and 30 7. C-reactive protein (CRP) concentration- Days 1 and 2 postop. 8. Proportion of patients requiring insulin 9. Hypoglycaemia rates 10. Hyperglycaemic rates 11. Other infections (i.e. non-SSI) at 30 days - see *Infections Diagnostic Definitions* 12. Sepsis- see *Infections Diagnostic Definitions* 13. Wound Dehiscence- partial or total disruption of any or all layers of the operative wound. 14. The relationship between diabetic status, glycaemic parameters (preoperative blood glucose, glycated haemoglobin (HbA1c)) and infective outcomes | — |
Countries
Australia, Hong Kong, Italy, Netherlands, New Zealand, United Kingdom
Outcome results
None listed