Prospective Randomized Study to Evaluate the Use of DERMABOND ProPen (2-octylcyanoacrylate) in the Closure of Abdominal Wounds Versus Closure With Skin Staples in Patients Undergoing Elective Colectomy.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Wound healing
研究概览
简要总结
2-octylcyanoacrylate (2-OCA) has been used extensively in clinical practice in trauma, plastic surgery, orthopaedic surgery, emergency medicine and paediatrics. Most studies on 2-OCA to date have focused on closure of short wounds, and only one has included closure of abdominal wounds in the context of general surgery. Here, the investigators will look at the results of closure of abdominal wounds in patients undergoing elective colectomies with 2-OCA, which is commercially available to us, versus closure with skin staples, which is the current standard technique of skin closure employed in the Department of Colorectal Surgery, Singapore General Hospital. The primary objective was to measure effectiveness of 2-OCA in 2 respects - the adequacy of wound healing and cosmesis, and the incidence of superficial wound infection.
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
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing elective colectomies for benign or malignant conditions
- •Midline vertical incisions or skin crease incisions
- •Above the age of 21 years old
- •Able to make own valid informed decisions
排除标准
- •Patients undergoing surgery for recurrent or metastatic disease
- •Surgery for surgical emergencies such as acute abdomen or bleeding
- •Known allergy to DERMABOND ProPen Tissue Adhesive or any of its constituents (cyanoacrylate or formaldehyde)
- •Patients on immunosuppression
结局指标
主要结局
Wound healing
时间窗: 3 months
Patient satisfaction
时间窗: 3 months
次要结局
- Time taken for wound closure(Intraoperative)
- Superficial surgical site infections(3 months)
