Surgical Site Infection After Major SurgeryPhase 4PROMPTNCT07186634
PeRiOperative Medicine Platform Trial
A Phase 4 study testing Liberal inspired oxygen, Conservative inspired oxygen and Intermediate inspired oxygen in people with Surgical Site Infection After Major Surgery and Anaesthesia, run by Monash University at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection After Major Surgery, Anaesthesia, Major Complications
- What is being tested?
- Liberal inspired oxygen, Conservative inspired oxygen and Intermediate inspired oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,800 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Apr 2026to Dec 2035
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Australia1 site, 1 recruiting
- Recruiting
The Alfred
Melbourne, Victoria, 3004
Paul S Myles, DSc, 61390762000 ext. 63176, p.myles@alfred.org.au
Sophie Wallace K, PhD, +61390762651, s.wallace@alfred.org.au
New Zealand1 site, 1 recruiting
- Recruiting
Wellington Hospital
Wellington, NZ, 6012
About this study
Official title: Domain-Specific Appendix: OXYGEN
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.
Read the detailed description
www.promptssi.org.au
- Conditions
- Surgical Site Infection After Major Surgery, Anaesthesia, Major Complications, Quality of Recovery (QoR-15), Quality of Life
- Being tested
- Liberal inspired oxygen, Conservative inspired oxygen, Intermediate inspired oxygen
- Keywords
- Anaesthesiology, complications, oxygen, surgery, platform trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberal inspired oxygenDrug
The concentration of Oxygen will differ according to the randomisation
Conservative inspired oxygenDrug
Conservative inspired oxygen
Intermediate inspired oxygenDrug
Intermediate inspired oxygen
| Study group | Role | What they receive |
|---|---|---|
| Liberal inspired oxygen | Active comparator | FiO2 0.8; i.e. 80% Receives: Drug: Liberal inspired oxygen |
| Conservative inspired oxygen | Active comparator | FiO2 ≤0.3 [30%] Receives: Drug: Conservative inspired oxygen |
| Intermediate inspired oxygen | Active comparator | FiO2 0.5 [50%] Receives: Drug: Intermediate inspired oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (6)
Health Care Associated Infections
pneumonia, blood stream infection and urinary tract infection
Measured: 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)
Measured: 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
Measured: 30 days
Mortality
All cause
Measured: 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.
Measured: 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).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start6 Apr 2026
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Site Infection After Major SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- conservative (≤30%), intermediate (50%), or liberal (80%) inspired oxygen concentration
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 7,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- The Alfred, Wellington Hospital
- Responsible party
- Sponsor
- Investigators
- Paul s Myles, DSc, Principal investigator, Monash UniversityTrisha Peel, PhD, Principal investigator, Monash UniversityDaniel Frei, PhD, Principal investigator, Wellington Reginal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186634
- Sponsor's protocol ID
- 2025-49324-130781
- Other IDs
- 2025
- Acronym
- PROMPT
- Status last verified
- Apr 2026
- First submitted
- 15 Sep 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Dependent on Ethics Committee (IRB) approval, a clinically important hypothesis and valid protocol
Publications
Myles PS, Peel TN, Webb S, Wallace SK, Brown WA, Corcoran T, Bucknall T, Coulson T, Frei D, Mitchell B, Ayton D, Higgins AM, Forbes A, Spencer R, Ryan EG. A perioperative medicine platform trial (PROMPT) evaluating interventions to reduce the risk of infection and other major complications after surgery: rationale and design. BJA Open. 2026 Aug 28;19:100855. doi: 10.1016/j.bjao.2026.100855. eCollection 2026 Sep.
PubMed 42701421
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Domain-Specific Appendix: OXYGEN
- ClinicalTrials.gov ID
- NCT07186634
- Acronym / sponsor ID
- PROMPT / 2025-49324-130781
- Conditions
- Surgical Site Infection After Major Surgery, Anaesthesia, Major Complications, Quality of Recovery (QoR-15), Quality of Life
- Keywords
- Anaesthesiology, complications, oxygen, surgery, platform trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7,800 participants (estimated)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- The Alfred, Wellington Hospital
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
www.promptssi.org.au
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- conservative (≤30%), intermediate (50%), or liberal (80%) inspired oxygen concentration
| Arm | Type | Receives |
|---|---|---|
| Liberal inspired oxygen | Active comparator | Drug: Liberal inspired oxygenFiO2 0.8; i.e. 80% |
| Conservative inspired oxygen | Active comparator | Drug: Conservative inspired oxygenFiO2 ≤0.3 [30%] |
| Intermediate inspired oxygen | Active comparator | Drug: Intermediate inspired oxygenFiO2 0.5 [50%] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liberal inspired oxygenThe concentration of Oxygen will differ according to the randomisation | Drug | Liberal inspired oxygen |
| Conservative inspired oxygenConservative inspired oxygen | Drug | Conservative inspired oxygen |
| Intermediate inspired oxygenIntermediate inspired oxygen | Drug | Intermediate inspired oxygen |
Primary outcome
Surgical Site Infection
Time frame: 30 days
A post operative infection that develops at the site of an operation, caused by bacteria entering the body through the surgical incision
6 secondary outcomes
Health Care Associated Infections
Time frame: 30 days
Quality of recovery
Time frame: 3 and 30 days after surgery
major postoperative complications
Time frame: 30 days
Mortality
Time frame: 30 days
EQ-5D-5L
Time frame: 30 days
DAH 30
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Derived from this study: PubMed 42701421Myles PS, Peel TN, Webb S, Wallace SK, Brown WA, Corcoran T, Bucknall T, Coulson T, Frei D, Mitchell B, Ayton D, Higgins AM, Forbes A, Spencer R, Ryan EG. A perioperative medicine platform trial (PROMPT) evaluating interventions to reduce the risk of infection and other major complications after surgery: rationale and design. BJA Open. 2026 Aug 28;19:100855. doi: 10.1016/j.bjao.2026.100855. eCollection 2026 Sep.
- Individual participant dataSharing planned: No. Dependent on Ethics Committee (IRB) approval, a clinically important hypothesis and valid protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul s Myles, DSc principal investigator
Monash University
Trisha Peel, PhD principal investigator
Monash University
Daniel Frei, PhD principal investigator
Wellington Reginal Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liberal inspired oxygen, Conservative inspired oxygen and Intermediate inspired oxygen in people with Surgical Site Infection After Major Surgery and Anaesthesia, run by Monash University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul S Myles, DSc (+6190762000 ext. 63176, p.myles@alfred.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07186634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.