Utility of 2- Octyl Cyanoacrylate (2-OCA) Skin Adhesive for Prevention of Fluid Leaks Following Therapeutic Paracentesis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Incidence of bleeding from site
研究概览
简要总结
Paracentesis is a commonly performed procedure in the inpatient and outpatient settings for treatment of ascites. The most frequent complication of paracentesis is fluid leak. Risk for this complication can be reduced by following the Z-track technique; however, fluid leaks still occur causing significant morbidity. 2-Octyl cyanoacrylate (2-OCA, Dermabond manufactured by Ethicon Inc) skin adhesive has been used for years for skin closure for wounds from surgical incisions including punctures from minimally invasive surgery and simple trauma lacerations.
详细描述
Paracentesis is a commonly performed procedure in the inpatient and outpatient settings for treatment of ascites. The most frequent complication of paracentesis is fluid leak. Risk for this complication can be reduced by following the Z-track technique; however, fluid leaks still occur causing significant morbidity. 2-Octyl cyanoacrylate (2-OCA, Dermabond manufactured by Ethicon Inc) skin adhesive has been used for years for skin closure for wounds from surgical incisions including punctures from minimally invasive surgery and simple trauma lacerations. It has also been used for treatment of ascites fluid leaks following paracentesis with success in case reports. While the initial FDA approval included a contraindication for use on mucosal surfaces, some evidence in literature suggests that use on mucosal surfaces might warrant further investigation. For example, 2-OCA has been used for repair of a lacerated tongue of a pediatric patient and for closure of congenital cleft lips
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients at Methodist Dallas Medical Center (MDMC) ≥18 years of age with ascites requiring therapeutic paracentesis performed by the procedure team at the bedside.
排除标准
- •Paracentesis procedures performed in the interventional radiology department or by physicians outside of the procedure team.
- •Patients who undergo a liver transplant surgery or other abdominal surgeries within 48 hours from the paracentesis procedure.
- •Patients that undergo paracentesis using a device or kit other than the 18 gauge Safe-T-Centesis kit
结局指标
主要结局
Incidence of bleeding from site
时间窗: up to 1 year.
local irritation/burning, infections, and/or perforation within 48 hours post-procedure and topical 2-OCA application.
Number of participants with Evidence of Skin Reactions
时间窗: up to 1 year
itching, burning, sensation, redness, dermatitis
Access the rate of complications
时间窗: up to 1 year
Assess the rate of complications after topical 2-OCA application post-paracentesis such as skin infections, peritonitis, perforation of viscus, and bleeding.
Access post-paracentesis fluid leaks
时间窗: up to 1 year
Incidence of post-paracentesis fluid leaks within 48 hours of paracentesis and topical 2-OCA application
Access topical 2-OCA application
时间窗: up to 1 year
To assess if topical 2-OCA application for skin closure would prevent post-paracentesis fluid leaks.
Number of participants with complications from paracentesis procedure
时间窗: up to 1 year
Cellulitis, peritonitis, bleeding, perforated viscus
次要结局
未报告次要终点