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

Not Applicable

Recruiting

• Conditions: Supplemental Oxygen; Gynecological Cancer; Surgical Site Infections

• Registration Number: NCT06780813
• Lead Sponsor: National and Kapodistrian University of Athens

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.

Detailed Description

This study aims to investigate the prophylactic value of postoperative oxygen administration against the development of wound infections in obese gynecological oncology patients undergoing laparotomy for the treatment of endometrial or ovarian cancer. At the same time, the factors that lead to an increase in this risk will be outlined.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-09
• Study Start: 2025-01-10
• Study First Submitted QC: 2025-01-15
• Last Update Submitted: 2025-01-15
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Primary Completion: 2026-01-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Surgical site infections	Within 30 days from the operation	Surgical site infections will be evaluated using the Southampton wound scoring system
Systemic inflammatory response syndrome	Within 30 days from the operation	The proportion of patients developing SSI-related systemic inflammatory response will be documented

Secondary Outcome Measures

Name	Time	Method
Need for surgical debridement	Within 30 days from the operation	Need for surgical debridement (bedside or on the operation theatre)
Seroma formation	Within 30 days from the operation	The development of wound seroma will be recorded
Wound hematoma	Within 30 days from the operation	The formation of wound hematoma will be evaluated
Uncomplicated wound healing	Within 30 days from the operation	The proportion of patients with no apparent wound healing problems will be documented
Additional wound assisting devices	Within 30 days from the operation	The need for vacuum assisted wound healing will be documented
Antibiotic coverage	Within 30 days from the operation	The need for supplemental antibiotic coverage will be documented
Multidrug resistant pathogens	Within 30 days from the operation	The proportion of patients with multidrug-resistant pathogens involving SSI will be documented
Duration of hospitalization	Within 30 days from the operation	The total duration of hospitalization will be documented
Hospital readmissions related to SSI	Within 30 days from the operation	Readmissions related to SSIs will be documented

Trial Locations

Locations (1)

First department of Obstetrics and Gynecology; 🇬🇷 Athens, Greece