A perioperative medicine platform trial (PROMPT) evaluating interventions to reduce the risk of infection and other major complications after surgery: rationale and design.

BACKGROUND: Platform trials are an extremely powerful, cost-effective innovation in clinical trial design and evidence-to-practice translation. As questions are answered progressively, additional new interventions, within the same or new domains, are substituted into the platform. This design is ideal for evaluation of interventions aiming to reduce surgical site infection, which remains the most common serious complication after surgery. OBJECTIVE: To efficiently identify effective, ineffective, or harmful treatments to reduce the incidence of perioperative infections and other major complications after surgery. STUDY DESIGN: Perioperative medicine adaptive platform trial (PROMPT) is a multicentre, Bayesian adaptive platform trial designed to reach conclusions regarding superiority, efficacy, equivalence, inferiority, harm, or futility. Modules within the protocol include the master protocol, multiple domain-specific appendices, and a statistical appendix. STUDY POPULATION: Adult patients undergoing a broad range of surgical procedures in participating hospitals. INTERVENTIONS: Specific interventions under study will be described in domain-specific appendices. The first intervention under study is liberal inspired oxygen concentrations during surgery. OUTCOMES: The primary outcome is the incidence of surgical site infection up to 30 days after index surgery; this will apply to all domains unless otherwise specified in a domain-specific appendix. Secondary outcomes include other health care-associated infections and major postoperative complications up to 30 days after surgery, quality of recovery (QoR-15) at 3 and 30 days after surgery, and days alive and at home up to 30 days after surgery (DAH30). CONCLUSIONS: PROMPT is designed to efficiently evaluate interventions aiming to reduce surgical site infection and other major complications after surgery. CLINICAL TRIAL REGISTRATION: NCT07186634. PROTOCOL VERSION NUMBER AND DATE: 1.1, December 4, 2025.