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Method of Exit Site Care in Chronic Peritoneal Dialysis Patients

This study has been 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.))
Sponsor:
ClinicalTrials.gov Identifier:
NCT00416338
First Posted: December 28, 2006
Last Update Posted: May 10, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Chinese University of Hong Kong
  Purpose

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 Intervention Phase
Chronic Peritoneal Dialysis Device: film dressing by adhesive Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Exit site infection.

Secondary Outcome Measures:
  • Patient satisfaction / quality of life.

Enrollment: 11
Study Start Date: January 2007
Study Completion Date: May 2007
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Hong Kong
Department of Medicine & Therapeutics, Prince of Wales Hospital
Shatin, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Man-Ching Law, BN Renal Unit, Department of Medicine & Therapeutics, Prince of Wales Hospital, Hong Kong
  More Information

ClinicalTrials.gov Identifier: NCT00416338     History of Changes
Other Study ID Numbers: CRE-2006.401-T
First Submitted: December 27, 2006
First Posted: December 28, 2006
Last Update Posted: May 10, 2007
Last Verified: April 2007

Keywords provided by Chinese University of Hong Kong:
renal failure
infection
peritonitis