Method of Exit Site Care in Chronic Peritoneal Dialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Peritoneal Dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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film dressing by adhesive

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Man-Ching Law, BN

Role: PRINCIPAL_INVESTIGATOR

Renal Unit, Department of Medicine & Therapeutics, Prince of Wales Hospital, Hong Kong

Locations

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Department of Medicine & Therapeutics, Prince of Wales Hospital

Shatin, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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CRE-2006.401-T

Identifier Type: -

Identifier Source: org_study_id