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

NCT06780813 | Recruiting DMC

• 1 other identifier: 834/24
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Supplemental Oxygen; Gynecological Cancer; Surgical Site Infections

Keywords

Supplemental oxygen; Surgical site infections; Gynecological cancer

Outcome Measures

Primary Outcomes (2)

• Surgical site infections

  Surgical site infections will be evaluated using the Southampton wound scoring system

  Within 30 days from the operation

• Systemic inflammatory response syndrome

  The proportion of patients developing SSI-related systemic inflammatory response will be documented

  Within 30 days from the operation

Secondary Outcomes (9)

• Need for surgical debridement

  Within 30 days from the operation

• Seroma formation

  Within 30 days from the operation

• Wound hematoma

  Within 30 days from the operation

• Uncomplicated wound healing

  Within 30 days from the operation

• Additional wound assisting devices

  Within 30 days from the operation

Other Outcomes (3)

• Infectious morbidity

  Within 30 days from the operation

• Postoperative morbidity

  Within 30 days from the operation

• Non-SSI related hospital readmissions

  Within 30 days from the operation

Study Arms (2)

Supplemental oxygen

ACTIVE COMPARATOR

This group 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 case of normal oxygen saturation) for the first 2 postoperative days

Behavioral: Supplemental oxygen therapy

Control group

NO INTERVENTION

This group will not receive supplemental oxygen during the first two days of hospitalization

Interventions

Supplemental oxygen therapy BEHAVIORAL

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

Supplemental oxygen

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active immunosuppresion
• Preexisting infection of the abdominal wall
• Preexisting sepsis

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

First department of Obstetrics and Gynecology

Athens, 11528, Greece

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Nikolaos Thomakos, Associate Professor

  National and Kapodistrian University of Athens

  STUDY DIRECTOR

Central Study Contacts

Vasilios Pergialiotis, Assistant Professor

CONTACT

+302132162291; pergialiotis@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Patients will be assigned with computer-generated randomization in two groups: i) the group receiving 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 (phase of hemostasis and inflammation of the surgical wound as well as ii) the control group in which supplemental oxygen will not be administered beyond the basic indications (low saturation, respiratory dysfunction).

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 17, 2025
• Study Start: January 10, 2025
• Primary Completion: January 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)