NCT06780813

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Supplemental Oxygen
• Gynecological Cancer
• Surgical Site Infections

Interventions

Type	Name	Description
BEHAVIORAL	Supplemental oxygen therapy	In this grou participants will receive supplemental oxygen in the form of a Venturi mask upon low oxygen saturation in oximetry (SaO2\<95%) and a nasal oxygen mask in all other cases during the first 2 postoperative days

Timeline

• Start date: 2025-01-10
• Primary completion: 2026-01-01
• Completion: 2026-05-01
• First posted: 2025-01-17
• Last updated: 2025-01-17

Locations

1 site across 1 country: Greece