Design
PROMPT is a multicentre, embedded multifactorial platform trial that uses a Bayesian adaptive design framework to reach conclusions regarding the effectiveness of multiple therapeutic treatments to reduce the incidence of surgical site infection and major complications after surgery.
Primary endpoint
Surgical site infection
Secondary endpoints
Incidence of a composite of all other HCAIs (pneumonia, blood stream infection and urinary tract infection), major postoperative complications, quality of recovery (QoR-15) at 3 and 30 days after surgery, days alive and at home at 30 days (DAH30) after index surgery (reflecting the patient’s primary aim of a healthy recovery, reduced hospital costs and the impact/severity of serious complications, and avoiding re-admission), all-cause mortality, and cost-effectiveness (EQ-5D-5L) at 30 days after index surgery.
Safety endpoints
Cardiovascular events, thromboembolism, respiratory and other adverse events.
Domain 02
In this domain of PROMPT, participants meeting the platform-entry criteria for PROMPT and additional eligibility criteria for this domain (PROMPT-O2) will be randomly assigned to receive one of three interventions:
- Liberal inspired oxygen during surgery (FiO2 0.8; i.e. 80%)
- Intermediate inspired oxygen during surgery (FiO2 0.5 [50%])
- Conservative inspired oxygen during surgery (FiO2 ≤0.3 [30%])
Entry criteria
Scheduled to undergo a surgical procedure with a skin incision, expected duration of at least 2 hours, and a planned overnight hospital stay of at least 1 night (including, but not limited to, cardiac surgery, orthopaedic surgery, obstetric, or gynaecological surgery). Aged 18 years or over.
For further information
Please contact Paige Druce: paige.druce@monash.edu or admin@promptssi.org.au