Supplemental Administration of High Flow Oxygen to Enhance Postoperative Recovery and Reduce Infections in Obese Gynecological Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Surgical site infections
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Active immunosuppresion
- •Preexisting infection of the abdominal wall
- •Preexisting sepsis
研究组 & 干预措施
Control group
This group will not receive supplemental oxygen during the first two days of hospitalization
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
干预措施: Supplemental oxygen therapy (Behavioral)
结局指标
主要结局
Surgical site infections
时间窗: Within 30 days from the operation
Surgical site infections will be evaluated using the Southampton wound scoring system
Systemic inflammatory response syndrome
时间窗: Within 30 days from the operation
The proportion of patients developing SSI-related systemic inflammatory response will be documented
次要结局
- Seroma formation(Within 30 days from the operation)
- Uncomplicated wound healing(Within 30 days from the operation)
- Need for surgical debridement(Within 30 days from the operation)
- Wound hematoma(Within 30 days from the operation)
- Additional wound assisting devices(Within 30 days from the operation)
- Antibiotic coverage(Within 30 days from the operation)
- Multidrug resistant pathogens(Within 30 days from the operation)
- Duration of hospitalization(Within 30 days from the operation)
- Hospital readmissions related to SSI(Within 30 days from the operation)
研究者
Vasilios Pergialiotis
Assistant Professor
National and Kapodistrian University of Athens