ThePerioperative ADministration of Dexamethasone and Infection trial

Phase 4

Withdrawn

• Conditions: surgical site infections; wound infections; 10004018

• Registration Number: NL-OMON47052
• Lead Sponsor: Alfred Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 125

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

* Poorly controlled type 1 diabetes (HbA1c > 9.0%)
* Endovascular procedure with a small (< 5 cm length) skin incision
* Ophthalmic surgery
* Planned dexamethasone (or other corticosteroid) therapy ( e.g. history of intractable PONV, maxillofacial surgery, intracranial neurosurgery)
* Recent (< 2 weeks since end of treatment) infective episode requiring treatment with antibiotics
* Chronic antibiotic therapy (e.g. for bronchiectasis, cystic fibrosis etc)
* When surgery is indicated for an infective process (e.g. infected joint prosthesis)
* A history of allergy or adverse reaction to glucocorticoids
* Planned postoperative intubation or ventilation
* Concurrent immunosuppressive therapies
* Current or recent (within preceding 1 month) systemic use of glucocorticoids
* Surgical procedures within the preceding 2 months
* Known immunosuppressed state
* Known moderate or severe liver disease (Hepatitis A, B, C, with cirrhotic liver states, primary biliary cirrhosis, sclerosing cholangitis - any of these with portal hypertension and/or variceal bleeding)
* Dialysis-dependent renal failure
* When the index surgical procedure is expected to require a further surgical procedure within the subsequent 30 days.
* Metastatic cancer

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Surgical Site Infection at 30 days</p><br>