Secondary Versus Tertiary Wound Closure in High Risk Gynecologic Abdominal Surgical Incisions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Percentage Comparisons of Tertiary Wound Closure Versus Historical Controls Postoperative Day 30
研究概览
简要总结
The purpose of this research study is to determine if closing a surgical wound differently is better than the procedure that is currently used. The wound will be closed with what is considered "tertiary intent." This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery. The investigators also want to see how this new wound closure process affects your quality of life.
详细描述
Primary Objective
To compare the percentage of patients whose wound remained closed on postoperative day #30 after tertiary closure compared to historical controls who underwent secondary would closure. We are primarily looking at time to wound closure. We will be able to abstract this information from the postoperative clinic visit notes from patients in the "historical control" cohort. We will identify 20 patients with characteristics described in the inclusion criteria of this study who underwent laparotomy with secondary would closure during the calendar year 2018.
Secondary Objectives
To compare the proportion of acute and chronic wound infection in wounds closed with a tertiary closure technique to historical controls receiving a secondary wound closure.
To compare the length of stay of patients receiving a tertiary wound closure to historical controls receiving a secondary wound closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with high risk class II, class III, class IV abdominal wounds
- •Undergoing laparotomy for gynecologic related disorders
- •Patients undergoing laparotomy for both benign and malignant diagnoses will be included in this study
排除标准
- •Pregnancy
- •Allergy to triclosan
- •Patients undergoing HIPEC
研究组 & 干预措施
Tertiary Wound Closure
In the alternative tertiary wound closure, the wound will be partially closed rather than being left open. Sutures in the skin will be placed but not closed. A vacuum assisted closure device will be placed over the wound to help healing. After 4-7 days, the vacuum device will be removed, and the participant's doctor will close the wound.
干预措施: Tertiary Wound Closure (Procedure)
Historical Wound Closure
The standard approach to your wound would be to leave it partially open and let it heal over a period of 3-6 months ("secondary closure").
干预措施: Historical Wound Closure (Procedure)
结局指标
主要结局
Percentage Comparisons of Tertiary Wound Closure Versus Historical Controls Postoperative Day 30
时间窗: 30 days after tertiary wound closure
The percent of wound closure that occurs postoperative day #30 after tertiary wound closure as compared to historical controls receiving a secondary wound closure.
Number of Participants With Wound Closures Comparing Tertiary Wound Closure Versus Historical Controls Postoperative Day 30
时间窗: 30 days after tertiary wound closure
The number of surgical wounds that remained closed at postoperative day #30 after tertiary wound closure as compared to historical controls receiving a secondary wound closure.
次要结局
- Proportion of Patients Returning after Surgery(Up to 30 days after surgery)
- Proportions of Tertiary Technique Versus Historical Controls(30 days after tertiary wound closure)
- Length of Hospital Stay(Up to 3 months after surgery)
- Change of Quality of Life Questionnaire SF-36(Up to 3 months after tertiary wound closure)
- Number of Participants With Surgical Site Infections (SSI) for Tertiary Technique Versus Historical Controls(30 days after tertiary wound closure)
- Proportion of Patients Returning After Surgery(Up to 30 days after surgery)
- Quality of Life Questionnaire SF-36 (Version 1)(Up to 3 months after tertiary wound closure)