Method of Exit Site Care in Chronic Peritoneal Dialysis Patients

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Peritoneal Dialysis
• Intervention / Treatment: Device: film dressing by adhesive

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Department of Medicine & Therapeutics, Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Exit site infection.

Secondary Outcome Measures

Outcome Measure
Patient satisfaction / quality of life.

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Man-Ching Law, BN, Renal Unit, Department of Medicine & Therapeutics, Prince of Wales Hospital, Hong Kong

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: December 27, 2006
• First Submitted That Met QC Criteria: December 27, 2006
• First Posted (Estimate): December 28, 2006

Study Record Updates

• Last Update Posted (Estimate): May 10, 2007
• Last Update Submitted That Met QC Criteria: May 9, 2007
• Last Verified: April 1, 2007

More Information

Terms related to this study

• Keywords: infection; peritonitis; renal failure
• Other Study ID Numbers: CRE-2006.401-T