A Prospective Randomized Controlled Trial Comparing Cyanoacrylate Skin Adhesive With Staple for Surgical Incision Closure After Laparoscopic / Robotic Bowel Resection
试验速览
- 阶段
- 不适用
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Total management time of surgical wound
研究概览
简要总结
INTRODUCTION
Liquid skin adhesive (LSA) has benefits over other closure methods. Especially it is less invasive, quicker to apply, and better in cosmesis. Also LSA applied wounds need no post-care and its water-proof nature allows patients to take a shower immediate postoperative periods. While traditional sutures and skin staples are invasive and have infection chance requiring regular wound dressings, LSA is resistant against both water and microbial infection without need for postoperative dressings. Thus LSA-applied wounds need no professional care saving wound management cost.
This study investigated not only the safety and efficacy of LSA, but also the cost-effectiveness in the context of total wound management resources including man-power, time, and cost.
STUDY OBJECTIVE
Primary end point of this study is time requiring to manage surgical wound calculated as man hour. Secondary end points are wound related complication and cost for management of surgical wound.
STATISTICAL ANALYSIS
The target number of the enrollment were calculated under the hypothesis that the wound management time for stapler group would be 1560 sec and that for LSA group be 264 sec with 10% drop-out rate. The sample number calculation formula of the t-test for independent 2 groups were used. For two-sided validation with the significance level of 0.05, and the power of 0.8, 29 patients for each group were estimated.
详细描述
STUDY DESIGN
- Screening: replaced with preoperative examination
- chest X-ray, CBC, CEA, BUN/Cr, OT/PT, glucose, EKG, abdominopelvic CT (optional), chest CT (optional), PET-CT(optional), MRI(optional)
- Subject
- Experimental group: surgical wound closure with liquid skin adhesive
- Control group: surgical wound closure with stapler
- Randomization The patients were randomized just before surgery after anesthesia and were randomly assigned to either experimental or control group as to computer-generated random number in 1:1 manner.
- Study schedule
- The enrolled patients received an elective surgery within 30 days after screening.
- Surgical wound managers checked every enrolled patient from immediate postoperative period until discharge at least 1 time per day. Surgical wound managers were either surgical hospitalists (general surgery boards), surgical residents, or wound care specialist nurses. Incompletely healed wounds until discharge were managed regularly in out-patient clinics additionally. If wound complications were noted at any time point, standard treatment was given according to the patient's status regardless of assigned groups
- Wound management
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
- 否
入选标准
- •A. 19-year-old or older adults B. elective laparoscopic or robotic colorectal resection C. clean-contaminated surgery without any intraoperative contamination D. The longest incision should be 15cm or shorter E. participant should voluntarily sign inform consent form
排除标准
- •A. emergency surgery or conversion-to-open surgery B. the longest skin incision longer than 15cm C. intraoperative contamination due to intestinal perforation or any other reason D. ECOG grade 3 or higher E. patients who are not be able to receive surgery within 30 days after screening F. patients who are refused to sign the informed consent form voluntarily
结局指标
主要结局
Total management time of surgical wound
时间窗: postoperative day 60
Wound management time was defined as the time period from the moment of skin closure to the point when the wound was healed either during admission or in out-patient clinic. For LSA group, skin closure time was measured in second starting from when LiquiBand® was applied to the first skin incision to when LiquiBand® was completely dried up in all skin incisions. For stapler group, it was measured as the whole time in second spent to apply skin staplers to all skin incisions in about 1cm interval. Wound management was performed at least once a day in all patients. Time was measured when surgical wound manager inspected and performed wound dressing as required. It was defined as time in second starting from the moment a patient completely took off tops to the moment a surgical wound manager took off gloves on the completion of dressing.
次要结局
- Total management costs of surgical wound(postoperative day 60)
- Surgical wound related complication(postoperative day 60)