Efficacy of Negative Pressure Wound Therapy (NPWT) for Prevention of Wound Infection and Improvement of Wound Healing After Stoma Reversal
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Surgical Site Infection (SSI) rate comparison
研究概览
简要总结
Stoma reversal is associated with high incidence of post-surgical complications, including Surgical Site Infections (SSI). Negative Pressure Wound Therapy (NPWT) has been successfully applied to surgical wound management, reducing the SSIs incidence. This is a randomized open-label trial to assess the efficacy of NPWT in decreasing the rate of SSI after stoma reversal.
详细描述
Stoma reversal after abdominal resection is associated with several complications, of which the most common is wound infection. Surgical Site Infections (SSI) usually result in increased long-term complications, such as incisional hernia, prolonged hospital stay, increased outpatients visits and medical costs. Negative-Pressure-Wound-Therapy (NPWT) is a technique using vacuum dressing, commonly used to promote surgical wound healing, but there is a significant lack of knowledge about its safety and efficacy in promoting wound healing after stoma closure. This is an interventional, randomized, open label trial to evaluate the safety and efficacy of the NPWT (PICO™ system, Smith&Nephew Healthcare, Hull, UK) on stoma wound compared to Standard of Care (SOC).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years, any sex;
- •Patients who underwent elective open or laparoscopic rectal resection ostomy construction (loop/end ileostomy; loop/end colostomy) for either oncological and Inflammatory Bowel Disease (IBD) indications;
- •Normal water contrast enema prior to surgery;
- •Both neo-adjuvant and adjuvant treatment are allowed for cancer patients;
- •Both immunosuppressant and biological medications are allowed for IBD patients.
排除标准
- •Patients age at screening < 18 years;
- •Pregnant or breastfeeding women;
- •Neurodegenerative disorders or psychiatric diseases;
- •Contraindications or hypersensitivity to the use of the investigational product or its components;
- •Patients with skin features (e.g., tattoos, pre-existing scarring) which could interfere with the study assessments;
- •Patients with post-operative bleeding (to be assessed 24 hours after surgery).
结局指标
主要结局
Surgical Site Infection (SSI) rate comparison
时间窗: Post-operative day 30
The rate of superficial (infections involving only the skin and subcutaneous tissue) or deep (infections involving the muscle and the fascia but not organ space) SSI will be assessed by medical examination
次要结局
- Wound healing timing comparison(Post-operative day 30)
- Quality of life assessment(Post-operative day 180)
- Pain assessment(Post-operative day 180)