Incisional Negative Pressure Wound Therapy Following Colorectal Resection: a Single Site, Prospective, Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 主要终点
- Superficial Surgical Site Infection (SSI)
研究概览
简要总结
Surgical Site Infections (SSIs) and wound complications are common occurrences following colorectal resection surgery. Incisional Negative Pressure Wound Therapy (iNPWT) has developing evidence for improving wound complication rates in certain populations. However, there have been no RCTs to date that have looked at iNPWT use after colorectal surgery. We propose a study in which patients are randomized into one of two treatment arms: 1) incisional NPWT, and 2) standard sterile gauze dressings. Patients will be followed for 30 days for diagnosis of infection or wound complication. We will compare primary outcomes in each group using Chi-Squared statistical testing in order to report a Absolute Risk Reduction and Number Needed to Treat
详细描述
Purpose: To evaluate if incisional Negative Pressure Wound Therapy (iNPWT) confers a lower rate of Surgical Site Infection (SSI) or wound complication compared to standard treatment of elective colorectal resection laparotomies.
Justification: Colorectal resection with bowel anastomosis is a clean-contaminated procedure known to have increased rates wound complication. Techniques like the use of incisional wound barriers, antimicrobial eluding dressings or iodine washout have been assessed in an attempt to reduce occurrence. However, evidence for their efficacy is not compelling for surgeons to universally adapt. Meanwhile, negative pressure wound therapy has demonstrated impressive efficacy in the management of complex and non-healing wounds. And recently, NPWT has become an area of interest in managing, not only open wounds, but closed wounds as well. The benefit of this therapy is yet to be clearly defined in the elective colorectal resection patient population, however.
Null hypothesis: There is no difference in SSI or wound complication rate in standard and iNPWT groups.
Design: Single-institution, prospective, randomized, open-label, superiority trial
Statistical Analysis
Assuming a complication rate of 20-30% and a relative risk reduction of 50%, we will recruit 400 patients (200 in each group) to achieve a power of 80% and type 1 error of 0.05. Primary endpoints will be: Wound Complication - defined as presence of seroma, hematoma, dehiscence, SSI - and SSI reported independently. Secondary endpoints will include: Length of Stay, ER visits related to SSI, Complications (according to Clavien-Dindo classification), need for and duration of home care related to wound care, and wound VAC specific complications (local reaction to adhesive dressing, blisters, failure of vacuum, need for early removal). Primary endpoints will be assessed according to intention-to-treat principle using Pearson's chi-squared test. In the event that baseline characteristics are significantly different, a secondary analysis using multivariable logistic regression will adjust for the effect of the difference. A p value of < 0.05 will be used to determine significance. Results will be presented as an absolute risk reduction as well as number needed to treat to prevent one wound complication. Secondary outcomes will be compared using a Mann-Whitney U-test for non-normally distributed continuous variables and chi-squared for categorical data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •elective colorectal resection for benign or malignant disease
- •surgery involves an anastomosis
- •open or minimally invasive technique
- •midline laparotomy used for specimen extraction
排除标准
- •allergy/sensitivity to adhesives
- •immunocompromised
- •emergency surgery
- •elective surgery
- •additional procedures performed at time of surgery
结局指标
主要结局
Superficial Surgical Site Infection (SSI)
时间窗: 30 days post op
Infection occurring within the first thirty days after surgery with at least one of the following: 1) purulent drainage from the superficial incision; 2) organisms obtained from an aseptically obtained culture of tissue or fluid from the superficial incision; 3) at least one of the local signs of infection; 4) superficial incision deliberately opened by the surgeon (unless the culture is negative)
Wound Complication
时间窗: 30 days post op
At least one of the following: 1) seroma; 2) hematoma; 3) SSI; 4) wound dehiscence/disruption
次要结局
- Post Op Complications(30 days post op)
- Need for and duration of home care(30 days post op)
- Blistering/reaction to wound dressings(3 days post op)
- Length of stay(approximately 5-10 days on average)
- Wound-related visits post surgery(30 days post op)