Method of Exit Site Care in Chronic Peritoneal Dialysis Patients
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|ClinicalTrials.gov Identifier: NCT00416338|
Recruitment Status : Terminated (We encounter technical problems to continue with the study. (Notably difficulty in teaching the patients to use the dressing set involved in the study.))
First Posted : December 28, 2006
Last Update Posted : May 10, 2007
Peritoneal dialysis accounts for more than 70% of the dialysis modality in Hong Kong. Exit site infection (ESI) is one of the causes leading to peritoneal catheter removal. Appropriate exit-site care can prevent ESI. As the presence of a causative organism is essential in ESI, eliminating organism invasion may be useful in preventing ESI. In the present study, an exit site care method aiming at preventing organism invasion is developed to investigate its effectiveness in reducing ESI. It is also hoped the present study can help to develop an exit site care method that can reduce the frequency of exit site dressing so as to reduce the burden of patients and to improve their quality of life.
We’ll recruit one hundred new chronic peritoneal dialysis patients into the study. The patients will be divided into two groups. One group of the patients will use film-dressing method (F) and the other group will use simple gauze dressing method (G). F group patients will have the exit site covered with a dressing film and keep it intact for 7 days after having the exit site cleaned with antiseptic solution. G group patients will clean the exit site with antiseptic solution and change the simple gauze dressing daily.
The outcomes of the two groups will be compared. The outcome will be expressed in terms of exit site infection free period, peritonitis free period and exit site condition classification. Patient subjective quality of life will also be compared at first and twelfth month.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Peritoneal Dialysis||Device: film dressing by adhesive||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Two Exit-Site Care Methods, Film Dressing (F) Method and Simple Gauze Dressing (G) Method, in Chronic Peritoneal Dialysis (CPD) Patients|
|Study Start Date :||January 2007|
|Actual Study Completion Date :||May 2007|
- Exit site infection.
- Patient satisfaction / quality of life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416338
|Department of Medicine & Therapeutics, Prince of Wales Hospital|
|Shatin, Hong Kong|
|Principal Investigator:||Man-Ching Law, BN||Renal Unit, Department of Medicine & Therapeutics, Prince of Wales Hospital, Hong Kong|