A Prospective, Randomized, Parallel Study Comparing Transdermal, Continuous Oxygen Delivery to Standard of Care to Assess Postoperative Wound Infection Rate in Colon and Rectal Resections
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Number of patients with surgical site infections measured with the Southampton Scoring System. The number of subjects with infection of the surgical site will be compared using chi-square or Fisher Exact test.
研究概览
简要总结
EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site infections (SSI).
详细描述
Anorectal procedures more often lead to surgical site infections. Such infections are unfortunately frequent and can be difficult for the patient and the treating physician. Wound hypoxia has been identified as a pathogenic mechanism behind wound infection and poor healing. Transdermal oxygen delivery (EPIFLO) is intended to promote the healing process in chronic wounds as an adjunct to standard wound care in wound management and treatment
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective colo-rectal surgery with or without anastomosis and with or without stoma
- •Patient age: 18-80
排除标准
- •Pregnancy
- •Anesthesiology ASA score of 4 or above
- •fever or existing signs of infection at the time of surgery
- •Diabetes Mellitus type I or II with HbA1C level 12% or more
- •Persons with decubitus or diabetic ulcers
- •Subjects with peritoneal metastases
- •Patients with severe malnutrition as indicated by Prealbumin value of <20
研究组 & 干预措施
Transdermal Continuous Oxygen Therapy
EPIFLO® working study unit, all day, every day for 2 - 4 weeks + standard wound care
干预措施: Epiflo (Device)
Standard of care
standard wound care for 4 weeks
结局指标
主要结局
Number of patients with surgical site infections measured with the Southampton Scoring System. The number of subjects with infection of the surgical site will be compared using chi-square or Fisher Exact test.
时间窗: 30 days
The primary objective of this study is to assess surgical site infection within 30 days of surgery for "high risk" patients undergoing colo-rectal surgery in patients receiving adjunct Transdermal Continuous Oxygen therapy vs. standard of care control Measures as either yes infection or no infection
次要结局
- Resource utilization - cost of treatments, hospital stays, bandages, nursing care(30 days)
- Number of days until patients surgical site is healed(30 days)
- Severity of infection measured with the Southampton Scoring System(30 days)