Using extra oxygen to prevent infections in obese women with gynecological cancer
Supplemental Administration of High Flow Oxygen to Enhance Postoperative Recovery and Reduce Infections in Obese Gynecological Cancer Patients
This study tests if giving extra oxygen after surgery can help prevent infections in obese women with gynecological cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | National and Kapodistrian University of Athens Academic / other |
| Locations | 1 site (Athens) |
| Trial ID | NCT06780813 on ClinicalTrials.gov |
What this trial studies
This study investigates whether providing supplemental oxygen after surgery can reduce the risk of surgical site infections in obese women undergoing laparotomy for gynecological cancers such as endometrial or ovarian cancer. The research focuses on patients with a body mass index (BMI) over 30 and aims to identify factors that contribute to increased infection risk. By improving tissue oxygenation, the study seeks to enhance wound healing and minimize complications that can prolong hospital stays and increase healthcare costs.
Who should consider this trial
Good fit: Ideal candidates for this study are obese women with gynecological cancer who are scheduled for laparotomy and meet specific preoperative health criteria.
Not a fit: Patients with active immunosuppression, preexisting infections, or sepsis are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of surgical site infections and improve recovery outcomes for obese gynecological cancer patients.
How similar studies have performed: While there is ongoing debate regarding the efficacy of supplemental oxygen in reducing infections, this study aims to fill a gap in the existing literature, as relevant data is currently lacking.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Athens
- First department of Obstetrics and Gynecology — Athens, Greece (Recruiting)
Study contacts
- Study coordinator: Vasilios Pergialiotis, Assistant Professor
- Email: pergialiotis@yahoo.com
- Phone: +302132162291
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.