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

National and Kapodistrian University of Athens

Status: Enrolling

Conditions: Gynecological Cancer; Supplemental Oxygen; Surgical Site Infections

Treatments: Behavioral: Supplemental oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06780813

834/24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Supplemental oxygen

Active Comparator group

Description:

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

Treatment:

Behavioral: Supplemental oxygen therapy

Control group

No Intervention group

Description:

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