Recruiting PHASE4 Surgical Site Infection After Major Surgery

New treatment option for Surgical Site Infection After Major Surgery

Official title PeRiOperative Medicine Platform Trial

ClinicalTrials.gov ID: NCT07186634

What this study is testing

What is Liberal inspired oxygen?

Liberal inspired oxygen is an investigational medicine, being studied as a potential treatment for surgical site infection after major surgery.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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).
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • PROMPT -
  • 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...

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • PROMPT -
  • 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...
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Melbourne, Victoria, Australia
  • Wellington, NZ, New Zealand

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Melbourne, Victoria, Australia; Wellington, NZ, New Zealand. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.