Effects by Omission of Bandage Over Exit Site at Patients in Peritoneal Dialysis (PD).Randomized Controlled Cross-over Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Healthy unbroken skin
研究概览
简要总结
Peritoneal dialysis, known as p- dialysis (PD), is a dialysis form in which the blood is purified by using the body's peritoneum. PD dependents on good access to peritoneum. For this, a catheter is implanted in the peritoneum and tunneled 2-3 cm below the skin. The way out is called exit site and is close to the navel.
Patients are selected at random to use bandage or not use bandage for three months, then cross-over. The overall objective of the research is that the patient in PD maintains a complete and healthy skin without signs of infection around the exit site. In the study effects by omission of bandage over exit site at patients in PD are examined when the patients are in a stable process with PD. The patient's exit site is assessed according to skin character and examined for infection.
The hypothesis is that there is no greater rate of infection in patients without bandage than in patients with bandage over the exit site, and that patients without bandage will have stronger skin around exit site.
详细描述
Background: For a patient in a stable (PD) there is no evidence for using bandage over exit site. Guidelines refer to this as an unsolved question.
An exit site infection can lead to tunnel infection and to peritonitis, which can be fatal. For this reason it is very important to prevent exit site infections and at the same time it is very important to reduce antibiotic which is a general problem in health care. (In Denmark, the patient does not use antibiotic cream around exit site, preventive.) Few years back, the care of the exit site was associated with sterile techniques, and the use of bandage was an obligatory procedure. The risk of infection appears now to be much less than first thought, but it is unclear what procedures are best: bandage or no bandage.
At present, most patients use bandage, but some patients drop it when bandage leads to maceration of the skin, allergy or wetness around the exit site. Other patients simply do not want to use bandage with subjective reasons. A dialysis catheter interferes with the patient's bodily life, integrity, autonomy and with the social sphere.
The nurses in the PD clinic at Aalborg University Hospital might have observed that patients without bandage do not get more infections around the exit site in relation to the patients using bandage. However, the study should develop evidence guidelines.
Objective: The aim of the study is to study the effects by omission of bandage over exit site at patient in PD when the patient is in a stable course. The purpose is that the patient maintains an unbroken skin without signs of infection around the exit site.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
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
- •Patients with uraemia chronic classified by ICD10 kode DN
- •The patients are in stable PD. Talk og understand Danish.
排除标准
- •Special reasons for protection of the exit site (- eg. critical illness, stay in areas with high risk of infection or body movements that require special fixation of the exit site) Mental impairment.
- •Symptoms of eczema around the exit site.
结局指标
主要结局
Healthy unbroken skin
时间窗: The patient is assessed after 6 months.
The primary endpoint is the condition of the skin around the exit site as measured by Sunnybrook PD Catheter Exit Site Assessment Tool prepared by Patsy Cho and colleagues. Following parameters are recorded: Redness, crust, swelling, pain, secretion.
次要结局
- Infection(The patient is assessed efter 6 months)
研究者
Edith Mark
Postdoc in Clinical Nursing
Aalborg University Hospital