Tegaderm(TM) Chlorhexidine Gluconate-gel (CHG) Dressing for the Prevention of Exit Site Infection in Patients Receiving Peritoneal Dialysis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The incidence rate of exit site infection
研究概览
简要总结
Exit site infection (ESI) is one of the major predisposing factors to peritoneal dialysis (PD) related peritonitis. Chlorhexidine Gluconate (CHG) has been widely used for cutaneous disinfection for half a century. TegadermTM CHG is a water-proof dressing with gel pads that provide 2% CHG to the skin surface and effectively prevents catheter-related infections for intravascular catheters. However, its use has not been accessed in patients with PD catheters. We aim to evaluate the effectiveness of TegadermTM CHG dressing in preventing ESI in PD patients.
详细描述
Peritoneal Dialysis (PD) is one of the common therapies for patients with End Stage Renal Failure (ESRF). As the global burden of chronic kidney disease continues to increase, so does the need for a cost-effective renal replacement therapy (1). Patient outcomes with peritoneal dialysis are comparable to or better than those with haemodialysis, and peritoneal dialysis is also more cost-effective (1). It is reported that PD improves patient's well-being and has greater personal freedom as compared to Hemodialysis through less restrictive life-style changes (2). All dialysis treatments include a certain risk of infection because of the decreased immune defenses of patients in established renal failure (ERF) and because dialysis techniques increase the potential of microbial contamination (3).
PD is associated with a high risk of infection of the peritoneum, subcutaneous tunnel and catheter exit site (4). ESI is diagnosed by the presence of purulent drainage, with or without erythema of the skin at the catheter-epidermal interface (5). Exit site infection (ESI) increases the possibility of developing PD peritonitis which demands careful attendance to these problems. It is estimated that 12% of cases of ESI results in PD peritonitis (6). As many as 15%-50% of ESRF patients are on PD, but recurrent or prolonged peritonitis may causes technique failure in PD (3). The majority of catheter related problems are of an infection nature - mainly represented by peritonitis (61%); ESI (23%); catheter obstruction, dislocation and leakage making up the rest (3). Peritonitis can be associated with severe pain leading to hospitalisation, catheter loss, and a risk of death; and it therefore continues to be a serious complication for PD patients (7).
There are no recommendations what topical care of the PD catheter exit site is optimal. Several methods including Povidone-Iodine, hydrogen peroxide, chlorhexidine, soap and water, and topical creams such as gentamicin or mupirocin cream have been studied for exit site care (8,9).
A number of topical cleansing agents have been studied for prevention of catheter-related infections however no cleansing agent has shown to be superior with respect to preventing catheter-related infections (5). The International Society for Peritoneal Dialysis (ISPD) recommends the use of daily topical application of antibiotic cream or ointment to the catheter exit site to prevent infection and exit site be cleansed at least twice weekly and every time after a shower (5).
Appropriate care of the exit site will avoid loss of catheter and unnecessary dialysis modality change. PD-related infection is the most common cause of technique failure. Prevention and treatment of PD catheter related infection such as peritonitis and exit site infections are important to maintain on PD therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All incident PD patients
排除标准
- •Patients allergic to chlorhexidine and Tegaderm dressing
结局指标
主要结局
The incidence rate of exit site infection
时间窗: 12 weeks
the rate in patient months and by percentage
次要结局
- PD-associated peritonitis(12 weeks)
- PD-related hospitalisation rate(12 weeks)
- time to first ESI and PD-associated peritonitis(12 weeks)
研究者
Allen Liu Yan Lun
Senior Consultant
National Healthcare Group, Singapore
