Chronic Peritoneal DialysisPhase 4NCT00416338
Method of Exit Site Care in Chronic Peritoneal Dialysis Patients
A Phase 4 study testing film dressing by adhesive in people with Chronic Peritoneal Dialysis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Peritoneal Dialysis
- What is being tested?
- film dressing by adhesive
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2007to May 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic renal failure patients with peritoneal catheter newly inserted
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Medicine & Therapeutics, Prince of Wales Hospital
Shatin
About this study
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.
- Conditions
- Chronic Peritoneal Dialysis
- Being tested
- film dressing by adhesive
- Keywords
- renal failure, infection, peritonitis
- Medical subject headings
- Renal Insufficiency, Infections, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
film dressing by adhesiveDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Exit site infection.
Secondary outcomes (1)
Patient satisfaction / quality of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study startJan 2007
- Study completionMay 2007
Why it stopped: We encounter technical problems to continue with the study. (Notably difficulty in teaching the patients to use the dressing set involved in the study.)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Peritoneal DialysisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Man-Ching Law, BN, Principal investigator, Renal Unit, Department of Medicine & Therapeutics, Prince of Wales Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416338
- Sponsor's protocol ID
- CRE-2006.401-T
- Status last verified
- Apr 2007
- First submitted
- 27 Dec 2006
- Last updated
- 10 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00416338
- Acronym / sponsor ID
- CRE-2006.401-T
- Conditions
- Chronic Peritoneal Dialysis
- Keywords
- renal failure, infection, peritonitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We encounter technical problems to continue with the study. (Notably difficulty in teaching the patients to use the dressing set involved in the study.)
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- May 2007 (actual)
- First posted
- 28 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic renal failure patients with peritoneal catheter newly inserted
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| film dressing by adhesive | Device | – |
Primary outcome
Exit site infection.
1 secondary outcome
Patient satisfaction / quality of life.
Results and safety
The study was stopped early (reason given: We encounter technical problems to continue with the study. (Notably difficulty in teaching the patients to use the dressing set involved in the study.)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2007.
Related trials for Chronic Peritoneal Dialysis
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
RecruitingObservational study
Continuous Glucose Monitoring in Patients With Diabetes on Peritoneal Dialysis
Kidney Disease, Chronic, Peritoneal Dialysis
RecruitingPhase 4
Bisacodyl Oral for Lowering Dysfunction (of Tenckhoff Catheter)
Renal Failure Chronic Requiring Dialysis, Peritoneal Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Man-Ching Law, BN principal investigator
Renal Unit, Department of Medicine & Therapeutics, Prince of Wales Hospital, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing film dressing by adhesive in people with Chronic Peritoneal Dialysis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: We encounter technical problems to continue with the study. (Notably difficulty in teaching the patients to use the dressing set involved in the study.)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exit site infection.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2007.