Open, Randomized, Controlled Non-inferiority Trial to Compare Synthetic Tissue Adhesive and Skin Suture After Port Catheter Implantation With Reference to Cosmetic Result and Economy of Time at Equal Risk for Wound Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Cosmetic outcome after wound healing
研究概览
简要总结
Port Wound Closure compares synthetic tissue adhesives with seam for cutaneous wound closure to port plant in terms of cosmetic results and time savings at comparable risk for wound infection.
详细描述
Study patients who undergo a subcutaneous venous port implant procedure are randomized into control group (conventional sutures) or into interventional group (synthetic tissue adhesive). The intervention time is documented. Follow-up visit is performed 8 weeks after port implantation. It includes a photo documentation, quality of life questionnaire (EQ5D) and pain scala questionnaire (POSAS) by patient and by 3 independent observers as well as the documentation of complications.
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 (Participant)
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
- •Medical indication for port catheter implantation because of chemotherapy or parenteral nutrition
排除标准
- •Children and adolescents < 18 years
- •Thrombocytes < 50/nl
- •PTT <50%
- •INR >1.5
- •Systemic or local infection of the interventional location
- •Known allergy to used material
- •Known allergy to Histoacryl, Cyanoacrylate, D&C Violett or Formaldehyd
- •General contraindication of port catheter implantation
研究组 & 干预措施
Suture
Skin incision closure with standard subcuticular technique
干预措施: Suture (Procedure)
Experimental: Histoacryl®
Skin incision closure with topic skin adhesive Histoacryl®
干预措施: Experimental: Histoacryl® (Device)
结局指标
主要结局
Cosmetic outcome after wound healing
时间窗: 8 weeks
Wound assessment by 3 independent evaluators (surgeons) and patient himself based on photo documentation
次要结局
- Infection rate(8 weeks)
- Economy of time for wound closure(10 minutes)
研究者
Ulf Teichgräber
Prof. Dr. med.
Jena University Hospital