None listed
Conditions
Brief summary
Background The tissue trauma of burn injury incites a unique cascade of inflammatory cytokines that leads to acute local and systemic complications. Chronic inflammation contributes to increased morbidity and mortality that persists for more than 20 years after injury. Scar quality is a global indicator of acute recovery and predictor of long term complications. Despite receiving optimal surgical management, almost half of injuries result in hypertrophic scarring. Adjunctive therapies to complement contemporary surgical burns management are urgently needed and non-steroidal anti-inflammatory drugs (NSAIDs) are prime candidates. Despite extensive and promising pre-clinical data, there have been no clinical trials. Aims By conducting a randomised controlled trial, we aim to answer the important, original research questions: (1) Does early and sustained use of the non-steroidal anti-inflammatory drug, celecoxib, following acute burn injury improve recovery as measured by scar quality at six weeks? (2) Does the use of celecoxib attenuate the persistent aberrant inflammatory response? Significance Scar quality is an important, patient centred outcome that reflects every intervention from the time of injury and is associated with long term quality of life. Annual costs of burn injury to WA Health are $11m with individual costs correlated with time to healing. Improving quality of recovery will facilitate return of physical and psychological wellness for the patients and reduce their need for ongoing healthcare.
Interventions
Celecoxib 200mg twice a day as oral capsules for six weeks in addition to standard care.
Adherence to allocated status will be in two phases. In hospital, administration will be recorded by nursing staff. At hospital discharge, participants will be provided with sufficient study medication to day 42. Participants will also be asked to complete a paper record of daily study drug administration. Study drug pill counts will be collected at the 42 day follow up.
Participants will receive routine c
Celecoxib 200mg twice a day as oral capsules for six weeks in addition to standard care. Adherence to allocated status will be in two phases. In hospital, administration will be recorded by nursing staff. At hospital discharge, participants will be provided with sufficient study medication to day 42. Participants will also be asked to complete a paper record of daily study drug administration. Study drug pill counts will be collected at the 42 day follow up. Participants will receive routine care at the discretion of the treating team. They will be permitted to have analgesia prescribed as per the departmental analgesia protocol and at discretion of anaesthetists, with the only exception being that participants will be prohibited from receiving any additional NSAID including aspirin.
Sponsors
Fiona Stanley Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Less than 48 hours from admission to the burns unit with acute burn injury OR Outpatient booked for day of surgery admission for management of acute burn injury
Exclusion criteria
i. Regular NSAID use prior to injury (including any dose aspirin) ii. Major burn with TBSA>20% or requiring admission to the intensive care unit iii. Enrolment not considered in the patient’s best interest iv. Previously enrolled in the CABIN Fever study v. Participating in a competing interventional study vi. Pregnancy or breast feeding vii. NSAID or sulphonamide allergy viii. Renal dysfunction (eGFR <60) ix. Angina, myocardial infarction, heart failure (NYHA class II or greater: ordinary physical activity results in fatigue, palpitations or dyspnoea) x. Previous history of peripheral arterial disease or stroke xi. Current use of angiotensin converting enzyme inhibitor or angiotensin II receptor blocker xii. Suspected or confirmed hepatic cirrhosis, portal hypertension or variceal bleeding xiii. Current ALT 3x upper limit of normal or Bilirubin 2x upper limit of normal xiv. Previous history of gastric ulcer or gastrointestinal bleeding xv. Current systemic corticosteroid use xvi. Suspected or confirmed haemophilia xvii. Current use of anticoagulant medications including warfarin, new oral anticoagulants (NOACs) such as apixaban, dabigatran and rivaroxaban and treatment dose heparin xviii. Suspected or confirmed thrombophilia or previous history of thromboembolism
Outcome results
None listed