Prospective Observational Study on the Safety and Efficacy of Cyanoacrylate Skin Glues to Reduce the Risk of Complications After Insertion of Totally Implantable Central Venous Catheters Port-a-Cath
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- visible presence of blood around the emergency site
研究概览
简要总结
The use of glue as a device in the implantation of central venous catheters has recently been introduced into European clinical practice, initially with the aim of blocking bleeding at the point of exit of the PICCs, but at the same time also to close the cutaneous incision practiced to create the PORT positioning pocket.
It is possible that the surgical incision created for the insertion of the PORT may undergo complications such as: local bleeding, infections or wounds of the surgical wound.
A solution to this problem could be the application of the cyanoacrylate dermal glue on the edges of the surgical wound, after intradermal suture. The glue would have the purpose of sealing the surgical wound so as to immediately seal the skin incision with hemostatic effect and create a potential barrier against infections.
详细描述
Patient's informed consent signature for adhesion at the study will be initially requested. With their acceptance, parameters will be recorded anonymously in the Case Report Form, identified by a numeric code, until hospital discharge.
The parameters analized will be related to:
- essential patient data (identification number, gender, age, height weight)
- basic diseases
- associated diseases and risk factors
- origin of the patient (department or home)
- reason for positioning
- hemorrhagic complications detected in the first 24 hours
- hemorrhagic complications detected in the first 7 days
- non-bleeding complications detected at 7 days (local and systemic infections, wound delescence)
The data wil be transferred to an Excel worksheet, in order to conduct a descriptive analysis related to every variable
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent signature
- •age > 18 years
排除标准
- •Age> 90 years
- •Cianoacrilate allergy
- •Presence of bacteraemia
- •Informed consent refusal
结局指标
主要结局
visible presence of blood around the emergency site
时间窗: 24 hours
Evaluate the effectiveness of cyanoacrylate glue in reducing / eliminating bleeding local from the insertion site after PORT implantation (evaluated as visible presence of blood around the emergency site.
次要结局
- Deischence of the surgical wound(15 days)
- Systemic infection(15 days)
- Early infection of the emergency site;(7 days)
研究者
Elena Giovanna Bignami
Professor
University of Parma