Comparison of Topical Skin Adhesive to Subcuticular Suture Closure of Implantable Port Incisions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Number of Participants With Complication of Wound Dehiscence
研究概览
简要总结
Hypothesis is that incision closure with octylcyanoacrylate is inferior to closure with stitches in Port a Cath patients, who, as a population, are at increased risk for complications. All adult patients who present for initial Port a Cath placement during the recruitment period will be eligible to participate in the study. Subjects will be randomized to either skin incision closure with standard stitches or closure with skin glue. Time to complete skin closure and costs of closure will be compared. Patients will be evaluated approximately one month and three months from the procedure to assess for complications of wound breakdown or infection, as well as for the appearance of the Port a Cath incision.
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
- Single (Outcomes Assessor)
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
- •All adult patients (≥18 years) who present for initial implantable port placement during the recruitment period will be eligible to participate in the study
排除标准
- •Patients who cannot provide informed consent for the procedure will be excluded from the study.
结局指标
主要结局
Number of Participants With Complication of Wound Dehiscence
时间窗: 3 months
To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.
Number of Participants With Complication of Infection
时间窗: 3 months
To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.
次要结局
- Healing-incision Cosmesis Score by Visual Analogue Scale(3 months)
- Closure Time(Baseline)
- Closure Materials Cost(Baseline)