The Role of Oxidized Regenerated Cellulose in Preventing Infections at the Surgical Site: Prospective, Randomized Study in 98 Patients Affected by a Dirty Wound
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- to reduce the microbial load and, consequently, the infection rate as compared to conventional local wound treatment
研究概览
简要总结
The purpose of this study is to determine whether oxidized regenerated cellulose (ORC) is effective to reduce the risk of surgical site infections (SSI).
详细描述
Surgical site infections (SSI) have significant clinical and economic repercussions since they still are the most common cause of nosocomial infections in surgical patients. It is important to bear in mind the growing number of SSI due to antibiotic-resistant microorganisms.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have an ileostomy or a colostomy
- •are candidates for an elective surgical procedure of ostomy closure
排除标准
- •immunodeficiency
- •chronic use of corticosteroids or antibiotics
- •chemotherapy and/or radiotherapy in the last 30 days before closure of the stoma
- •concomitant foci of infection
研究组 & 干预措施
group A-the treatment group
Group A-patients have their wound, the site of the previous stoma, wad with ORC
干预措施: oxidized regenerated cellulose (Fibrillar SURGICEL) (Device)
group B-the control group
control group-patients have their wound wad with iodoform gauze
干预措施: iodoform gauze (Device)
结局指标
主要结局
to reduce the microbial load and, consequently, the infection rate as compared to conventional local wound treatment
时间窗: third post-operative day
次要结局
未报告次要终点