Actively Recruiting
Supplemental Administration of High Flow Oxygen to Enhance Postoperative Recovery and Reduce Infections in Obese Gynecological Cancer Patients
Led by National and Kapodistrian University of Athens · Updated on 2025-01-17
400
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the impact of supplemental oxygen after surgery on wound infections and healing in obese women with gynecological cancers such as endometrial or ovarian cancer. The study focuses on whether giving extra oxygen after surgery can reduce surgical-site infections and related complications, which affect 10-20% of these patients and can extend hospital stays and costs. This research will also examine factors that increase infection risk in this group. Participants are randomly assigned to one of two groups. One group receives supplemental oxygen via a Venturi mask if their oxygen saturation is low (below 95%) or a nasal oxygen mask if normal, for the first two days after surgery. The other group does not receive supplemental oxygen during these first two postoperative days. This approach is being assessed for its ability to help wound healing and reduce infections. During the study, participants will be monitored for up to 30 days after surgery for surgical site infections and systemic inflammatory response syndrome, which are the main outcomes. Additional assessments include the need for surgical cleaning, fluid or blood collections in wounds, wound healing quality, use of wound devices, antibiotic use, presence of resistant bacteria, length of hospital stay, and readmissions due to infections. Researchers will track these outcomes closely to evaluate the effects of supplemental oxygen on recovery and safety.
CONDITIONS
Brief Title
Supplemental High Flow Oxygen to Reduce Infections in Obese Gynecological Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients with obesity (BMI >30 kg/m2) diagnosed with gynecological cancer
- Optimized preoperative blood counts (hemoglobin >11 g/dl, white blood cells 4,000-11,000 X 10^9/L, platelets 150,000-400,000 X 10^9/L)
- If receiving neoadjuvant therapy, at least three weeks have passed since the last treatment cycle
- Age between 18 and 85 years
You will not qualify if you...
- Active immunosuppression
- Existing infection of the abdominal wall
- Preexisting sepsis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 days
Participants undergo laparotomy surgery for gynecological cancer followed by supplemental oxygen therapy or no oxygen during the first 2 postoperative days.
Hospital stay including surgery and oxygen administration period
Duration - Up to 30 days
Participants are monitored for surgical site infections, wound healing, and other complications for up to 30 days after surgery.
Approximately 2 to 3 visits within 30 days post-operation
Trial Site Locations
Total: 1 location
1
First department of Obstetrics and Gynecology
Athens, Greece, 11528
Actively Recruiting
Research Team
V
Vasilios Pergialiotis, Assistant Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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