Chronic Peritoneal Dialysis Clinical Trial
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
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.
| Status | Terminated |
| Enrollment | 11 |
| Est. completion date | May 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - chronic renal failure patients with peritoneal catheter newly inserted Exclusion Criteria: - Patients have exit-site infection before stitches removal or presence of signs and symptoms of exit-site infection at the time of remove stitches. - Patients plan to move out of PWH or transplant soon after catheter insertion. - Patients have known history of allergy to adhesives / tapes. - Extremely non-compliant patients. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | Department of Medicine & Therapeutics, Prince of Wales Hospital | Shatin |
| Lead Sponsor | Collaborator |
|---|---|
| Chinese University of Hong Kong |
Hong Kong,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Exit site infection. | |||
| Secondary | Patient satisfaction / quality of life. |