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

Supplemental Administration of High Flow Oxygen to Enhance Postoperative Recovery and Reduce Infections in Obese Gynecological Cancer Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Surgical Site Infections; Gynecological Cancer; Supplemental Oxygen
• Intervention / Treatment: Behavioral: Supplemental oxygen therapy

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 Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vasilios Pergialiotis, Assistant Professor; Phone Number: +302132162291; Email: pergialiotis@yahoo.com

Study Locations

• Greece
  • Athens, Greece, 11528
    • Recruiting
    • First department of Obstetrics and Gynecology
    • Contact: Vasilios Pergialiotis, Assistant Professor; Phone Number: +302132162291; Email: pergialiotis@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Supplemental oxygen; 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; 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
No Intervention: Control group; This group will not receive supplemental oxygen during the first two days of hospitalization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infectious morbidity	Other infectious morbidity, including urinary tract, pulmonary and gastrointestinal infections will be recorded	Within 30 days from the operation
Postoperative morbidity	Postoperative morbidity non-related to SSI will be documented using the Clavien-Dindo scaling score	Within 30 days from the operation
Non-SSI related hospital readmissions	Hospital readmission rates that are not attributed to SSIs will be documented	Within 30 days from the operation

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens
• Investigators: Study Director: Nikolaos Thomakos, Associate Professor, National and Kapodistrian University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Surgical site infections; Gynecological cancer; Supplemental oxygen
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection
• Other Study ID Numbers: 834/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared for this study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No