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NCT06780813Recruiting

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

Supplemental Administration of High Flow Oxygen to Enhance Postoperative Recovery and Reduce Infections in Obese Gynecological Cancer Patients

Source: ClinicalTrials.gov · Last updated 17 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
400 (estimated)
First submitted
9 Jan 2025
Start date
10 Jan 2025
Primary completion date
1 Jan 2026
Lead sponsor
National and Kapodistrian University of Athens
Diseases
Obesity
NCT number
NCT06780813

What you commit to

  • Study type: Interventional
  • Planned participants: 400
  • From 10 Jan 2025 to the primary completion date, 1 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Preexisting infection of the abdominal wall

Other

  • Active immunosuppresion
  • Preexisting sepsis

Who the study is looking for

  • 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

Age in the registry: 18 years to 85 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
First department of Obstetrics and Gynecology
Coordinator of this site? Confirm its status
AthensGreeceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.