A Phase 4 interventional study of Liberal inspired oxygen and Conservative inspired oxygen in Surgical Site Infection After Major Surgery, Anaesthesia and Major Complications, sponsored by Monash University. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Monash University · Phase 4, Interventional, and Treatment
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.
www.promptssi.org.au
745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.
This study's planned enrollment of 7,800 is above the median of 200 across 581 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Monash University is the lead sponsor of 83 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
PROMPT - Inclusion Criteria:
PROMPT - Exclusion Criteria:
DSA 02 - PROMPT - Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FiO2 0.8; i.e. 80%
Drug: Liberal inspired oxygen
FiO2 ≤0.3 \[30%\]
Drug: Conservative inspired oxygen
FiO2 0.5 \[50%\]
Drug: Intermediate inspired oxygen
The concentration of Oxygen will differ according to the randomisation
Conservative inspired oxygen
Intermediate inspired oxygen
Surgical Site Infection
A post operative infection that develops at the site of an operation, caused by bacteria entering the body through the surgical incision
Time frame: 30 days
Health Care Associated Infections
pneumonia, blood stream infection and urinary tract infection
Time frame: 30 days
Quality of recovery
Quality of the individual's recovery post surgery - PROM. The scores of all 15 questions, with each item rated on a scale that results in a total score ranging from 0 (very poor recovery) to 150 (excellent recovery)
Time frame: 3 and 30 days after surgery
major postoperative complications
Description: A composite (and individually): Cardiovascular events (myocardial infarction, arterial or venous thrombosis, stroke, acute pulmonary edema, cardiogenic shock, new cardiac arrhythmia requiring treatment) Sepsis or septic shock (defined according to the Sepsis-3 definition)25 Respiratory complications - (i) pneumonia using US Centers for Disease Control criteria, (ii) Acute Respiratory Distress Syndrome using Berlin consensus definition, or (iii) the need for tracheal re-intubation and mechanical ventilation after extubation, and within 30 days after surgery OR mechanical ventilation for more than 24 h after surgery26 Unplanned intensive care unit (ICU) admission or readmission, defined as not anticipated preoperatively Acute kidney injury (based on the serum creatinine item of the Kidney Disease Improving Global Outcome criteria) Need for surgical re-intervention within 30 days after surgery Death within 30 days after surgery. Time Frame: 30 days
Time frame: 30 days
Mortality
All cause
Time frame: 30 days
EQ-5D-5L
Quality of life (EQ-5D-5L) at 30 days after index surgery. The resulting EQ-5D index score is a numerical value, with 1 representing full health, and scores less than 1 representing poorer health states, including negative values that indicate health states worse than death.
Time frame: 30 days
DAH 30
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 (often due to SSI).
Time frame: 30 days
Cost Analysis
Direct health care costs at 30 days after index surgery Number of quality-adjusted life years (QALYs) at 30 days after index surgery Cost effectiveness measured as a cost per QALY.
Time frame: 30 days
Plan to share: No — Dependent on Ethics Committee (IRB) approval, a clinically important hypothesis and valid protocol
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Monash University