NCT07186634 PeRiOperative Medicine Platform Trial
| NCT ID | NCT07186634 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Monash University |
| Condition | Surgical Site Infection After Major Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 7,800 participants |
| Start Date | 2026-04-06 |
| Primary Completion | 2035-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 7,800 participants in total. It began in 2026-04-06 with a primary completion date of 2035-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Our specific aims are to investigate whether conservative (≤30%), intermediate (50%), or liberal (80%) inspired oxygen during and immediately after surgery: Aim 1: Reduces surgical site infections (SSIs or "wound infections") and other healthcare-associated infections (pneumonia and sepsis). Aim 2: Reduces a pooled composite of serious postoperative complications, leading to a faster and more complete recovery after surgery, and thus increases "days alive and at home up to 30 days after surgery" (DAH30). Primary hypothesis: Liberal (80%) oxygen concentration delivered with anesthesia in patients undergoing major surgery reduces the incidence of SSIs after surgery compared to conservative (≤30%) or intermediate (50%) oxygen concentration. Secondary hypothesis: Hyperoxia (50-80%) delivered with anesthesia in patients undergoing major surgery increases the incidence of pulmonary and other complications after surgery compared to conservative (≤30%) oxygen concentration, resulting in fewer Days At Home (DAH). PROMPT enrolls patients undergoing elective or semi-elective surgery.
Eligibility Criteria
PROMPT - Inclusion Criteria: * Adult patient (≥18 years of age at time of admission) * Scheduled to undergo a surgical procedure involving a skin incision, with an 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, orthopedic surgery, obstetric, or gynecological surgery). PROMPT - Exclusion Criteria: * ASA physical status 5 (moribund, not expected to survive with or without an operation) * Inability to provide informed consent * Previous participation in PROMPT within the prior 30 days. DSA 02 - PROMPT - Exclusion Criteria: * ASA physical status 1 or 2 * Undergoing cardiac surgery * Undergoing thoracic surgery if one-lung ventilation is required * Currently suspected or proven infection * Advanced lung disease requiring home oxygen therapy * Previous bleomycin therapy * Known or suspected pregnancy
Contact & Investigator
Paul s Myles, DSc
PRINCIPAL INVESTIGATOR
Monash University
Frequently Asked Questions
Who can join the NCT07186634 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Surgical Site Infection After Major Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07186634 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07186634 currently recruiting?
Yes, NCT07186634 is actively recruiting participants. Contact the research team at p.myles@alfred.org.au for enrollment information.
Where is the NCT07186634 trial being conducted?
This trial is being conducted at Melbourne, Australia, Wellington, New Zealand.
Who is sponsoring the NCT07186634 clinical trial?
NCT07186634 is sponsored by Monash University. The principal investigator is Paul s Myles, DSc at Monash University. The trial plans to enroll 7,800 participants.