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

National and Kapodistrian University of Athens400 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

400

Conditions

Supplemental Oxygen Gynecological Cancer Surgical Site Infections

Interventions

Supplemental oxygen therapyBEHAVIORAL

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

First department of Obstetrics and Gynecology

Athens, Greece

RECRUITING