Идёт набор NCT06780813

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

Без фазы С лечением Supplemental Oxygen Gynecological Cancer Surgical Site Infections

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Supplemental oxygen therapy.
Кому может быть актуально: Состояния в реестре: Supplemental Oxygen, Gynecological Cancer, Surgical Site Infections. Базовые параметры: 18 лет — 85 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Греция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Поведенческое 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

Первичные конечные точки

Surgical site infections [Срок оценки: Within 30 days from the operation]
Systemic inflammatory response syndrome [Срок оценки: Within 30 days from the operation]

Вторичные конечные точки (9)

Need for surgical debridement [Срок оценки: Within 30 days from the operation]
Seroma formation [Срок оценки: Within 30 days from the operation]
Wound hematoma [Срок оценки: Within 30 days from the operation]
Uncomplicated wound healing [Срок оценки: Within 30 days from the operation]
Additional wound assisting devices [Срок оценки: Within 30 days from the operation]
Antibiotic coverage [Срок оценки: Within 30 days from the operation]
Multidrug resistant pathogens [Срок оценки: Within 30 days from the operation]
Duration of hospitalization [Срок оценки: Within 30 days from the operation]
Hospital readmissions related to SSI [Срок оценки: Within 30 days from the operation]

Критерии участия

Критерии включения

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