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临床试验/NCT04822467
NCT04822467已完成不适用

SQ53 Disinfectant Wipes for Prevention of Catheter Related Blood Stream Infection in Patients Receiving Home Parenteral Nutrition: A Single Blind Randomized Placebo-controlled Clinical Trial

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2021年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
2
主要终点
Number of Catheter-Related Blood Stream Infections (CRBSI) at 6 Months

研究概览

简要总结

SQ53 is a novel antimicrobial, sporicidal solution that is based on a platform of quaternary ammonium chloride compounds. It has been tested against a wide range of bacteria, viruses, spores and fungal pathogens. Extensive laboratory testing has demonstrated the effectiveness of SQ53 impregnated wipes in cleaning surfaces including catheters over a 24 hour plus time period. SQ53 also received an in vitro evaluation of the irritancy potential using a tissue engineered human skin model and was found to have no potential for skin irritation. SQ53 is available as a sterilized pack with a single wipe inside. The pack is easy to open by tearing off the top end and presenting the contents to the operator to remove under sterile conditions.

The current study will be a randomized single-blinded placebo-controlled clinical trial for SQ53 wipes intended for catheter cleaning in patients receiving home parenteral nutrition.

详细描述

Parenteral nutrition (PN) therapy is an essential component of medical management of patients suffering from intestinal failure. Depending on the underlying etiology and the type of intestinal failure, the duration of parenteral nutrition therapy could range from several weeks to several years, although a substantial proportion of these patients also require lifelong parenteral nutrition support. These patients continue the infusion of PN at their homes and are managed by the Cleveland Clinic's Home PN support team. These patients require Central Venous Catheters (CVC) for prolonged period of time for infusion of parenteral nutrition. The two most commonly used central catheters for TPN infusion are the Peripherally Inserted Central Catheter (PICC) and Tunneled CVCs. Catheter related blood stream infection (CRBSI) is a major complication of long-term CVCs. CRBSI is associated with high morbidity, mortality and healthcare cost. Additionally, CRBSI can also lead to an interruption in nutrient delivery, loss of work and productivity, premature vascular access device removal, and poor quality of life.

Prevention of CRBSI is an important component of clinical management of patients receiving home PN therapy. Several strategies have been adopted to reduce the incidence of CRBSI. A heparin lock solution was used in the past for many years; however, current nutrition society guidelines recommend normal saline locks instead of heparin locks. Published data has suggested that heparin locks have not proven to have a substantial effect on CRBSI prevention, and it paradoxically increases the infection risk due to biofilm production. Antibiotic locks have also been used, although this practice is largely not preferred due to increased risk of infections with resistant microorganisms. Taurolidine is another lock solution which has been studied in the countries outside the United States such as Canada; however, it has not been approved for the use in the U.S. yet.1

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients requiring home parenteral nutrition support via PICC line or tunneled CVC.

排除标准

  • Age less than 18 years
  • Women known to be pregnant
  • Women of childbearing age who are planning a pregnancy
  • Women who are breastfeeding
  • Patients who will not be managed by Cleveland Clinic HPN service
  • Patients who refuse to use disinfectant wipes daily.

结局指标

主要结局

Number of Catheter-Related Blood Stream Infections (CRBSI) at 6 Months

时间窗: 6 months

Reduction in the number of CRBSI experienced by participants over a six month period (1000 days)

次要结局

  • Catheter Exchange Rates(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Donald Kirby

Principal Investigator

The Cleveland Clinic

研究点 (2)

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