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Supplemental High Flow Oxygen to Reduce Infections in Obese Gynecological Cancer Patients

Study acronym: SAFE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 17, 2025 (before its estimated January 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The incidence of surgical-site infection (SSI) and complications related to wound healing reaches 10-20% of gynecological cancer patients. Each complication may dramatically prolong the hospitalization period and increase the economic burden of hospital care. Appropriate wound care and tissue oxygenation are of special importance for wound healing. Assuming adequate perfusion, the easiest, safest, and most effective way to improve tissue oxygenation is to increase the fraction of inspired oxygen. However, there is considerable controversy as to whether supplemental oxygen actually reduces SSI and healing-related complications as to date, there is absence of relevant data.
Trial Details
NCT Number NCT06780813
Lead Sponsor National and Kapodistrian University of Athens
Conditions Supplemental Oxygen, Gynecological Cancer, Surgical Site Infections
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov