NCT06780813 Supplemental High Flow Oxygen to Reduce Infections in Obese Gynecological Cancer Patients
| NCT ID | NCT06780813 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National and Kapodistrian University of Athens |
| Condition | Supplemental Oxygen |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2025-01-10 with a primary completion date of 2026-01-01.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: * Obese (BMI\>30kg/m2) gynecological cancer patients * Optimized preoperative CBC values (hemoglobin \>11g/dl, WBC 4.000-11.000 X 109/L, platelets 150,000 to 400,000 X 109/L) * In the case of neoadjuvant therapy an interval longer than three weeks between the last cycle and the operation Exclusion Criteria: * Active immunosuppresion * Preexisting infection of the abdominal wall * Preexisting sepsis
Contact & Investigator
Nikolaos Thomakos, Associate Professor
STUDY DIRECTOR
National and Kapodistrian University of Athens
Frequently Asked Questions
Who can join the NCT06780813 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 85 Years, studying Supplemental Oxygen. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06780813 currently recruiting?
Yes, NCT06780813 is actively recruiting participants. Contact the research team at pergialiotis@yahoo.com for enrollment information.
Where is the NCT06780813 trial being conducted?
This trial is being conducted at Athens, Greece.
Who is sponsoring the NCT06780813 clinical trial?
NCT06780813 is sponsored by National and Kapodistrian University of Athens. The principal investigator is Nikolaos Thomakos, Associate Professor at National and Kapodistrian University of Athens. The trial plans to enroll 400 participants.