Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06780813

Recruiting nowNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 85 Years

SexFemale

Healthy volunteersNot accepted

ConditionSupplemental Oxygen, Gynecological Cancer, Surgical Site Infections

Full registry criteria

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

Treatments and study arms

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

Primary outcomes

Surgical site infectionsWithin 30 days from the operation

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

Systemic inflammatory response syndromeWithin 30 days from the operation

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

First department of Obstetrics and Gynecology🇬🇷 Athens, Greece

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Vasilios Pergialiotis, Assistant ProfessorContact

Email · Call +302132162291