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临床试验/NCT03677063
NCT03677063已完成不适用

Usefulness of Sterile Adhesive Dressing at the Exit-site of Peritoneal Dialysis Catheter: a Pilot Study

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Infectious event

研究概览

简要总结

Infection of peritoneal dialysis fluid is a major complication in patients treated with peritoneal dialysis (PD). The aim of catheter emergence care is to reduce bacterial contamination of the peritoneum. The recommendations of the International Society of Peritoneal Dialysis do not provide information on the frequency of care delivery or the usefulness of a sterile adhesive dressing. Thus each treatment center applies a protocol of its own. Dressing is common practice although its safety and interest are not demonstrated.

The usefulness of dressing is still to be demonstrated. On the other hand, the efficacy of the application in prevention of a cream of mupirocin at emergence on the reduction of the risk of infection with staphylococcus aureus (SA), the most frequent germ found in peritonitis, has been demonstrated. A Spanish study showed that during a peritoneal infection at SA the site most frequently colonized by a similar strain of SA was the emergence of the catheter.

It can be considered that an infection of the dialysis liquid in PD is not only related to the quality of emergency care but also to manipulations during exchanges.

Given the number of patients involved in PD in France, it is difficult to obtain sufficient power to formally demonstrate the non-inferiority of the absence of dressing.

Therefore, the investigators propose a descriptive, exploratory study of events that may occur in PD when a dressing is not applied. This is a step prior to performing a multicenter randomized comparative study that will aim to show the non-inferiority of the absence of dressing compared to the application of a dressing on the incidence of fluid infection. peritoneal dialysis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • •patient who has been informed and has given free and informed consent
  • •patient affiliated to a social security scheme

排除标准

  • •inclusion of the patient in another biomedical research protocol that influences the risk of infection
  • •burial of the catheter before the initiation of dialysis treatment second attempt at treatment with peritoneal dialysis following catheter removal and resection
  • •patient under curatorq
  • •pregnant woman

研究组 & 干预措施

Dressing

No Intervention

It is the historical cohort which is composed of patients over 18 years of age treated by peritoneal dialysis in the nephrology department of Universty Hospital of Caen Normandie. Patients with the same non-inclusion criteria as the experimental group will not be included. The data will be extracted from the Registry of Peritoneal Dialysis of French Language. The number of patients included from the register can not be fixed in advance; this number will correspond to the 4-year follow-up at the start date of the study to ensure at least two years of patient follow-up

Usually care

First dressing 5 or 10 days after the pose of the catheter :

  • Cleaning emergence with antiseptic soap
  • Rinsing with saline
  • Drying
  • Application of a hazelnut mupirocin on the exit-site
  • Application of an occlusive dressing on the exit-site Then, care is the same. Exit-site care is performed daily if the patient takes a shower or twice a week.

No dressing

Experimental

No application of sterile dressing at the exit-site of periotoneal dialysis catheter for all patients (30 days after the placement of the peritoneal dialysis catheter)

干预措施: No dressing (Other)

结局指标

主要结局

Infectious event

时间窗: 24 months

Time until the occurrence of an infectious event: * Infection of Staphylococcus aureus peritoneal dialysis fluid (SA) within 24 months of follow-up * Infection of peritoneal dialysis fluid other than AS within 24 months of follow-up * Emergence infection during 24 months of follow-up * Peritonitis at SA and simultaneous presence of SA at emergence within 24 months of follow-up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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