Peritoneal Dialysis Catheter Exit Site InfectionNCT05143164
Hydrocolloid Dressing for Catheter Exit Site Care in Peritoneal Dialysis Patients
A study testing hydrocolloid dressing and Gentamicin Sulfate, Topical in people with Peritoneal Dialysis Catheter Exit Site Infection, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The study aims to examine the use of hydrocolloid dressing for catheter exit-site care in peritoneal dialysis patients. It is a pilot study, and participants will be randomized to either receiving weekly hydrocolloid dressing or daily topical gentamicin cream for exit-site care in peritoneal dialysis patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Peritoneal Dialysis Catheter Exit Site Infection
- What is being tested?
- hydrocolloid dressing and Gentamicin Sulfate, Topical
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 11 Mar 2022to 30 Dec 2025
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult peritoneal dialysis patients (≥ 21 years old) and are followed up at Singapore General Hospital (SGH)
Who cannot join
- Patients who are unable to provide valid consent, patients who have known allergy to hydrocolloid dressing, patients who have peritoneal dialysis catheter exit site infection or peritonitis within the past 3 months, patients who have dialysate leak at PD catheter exit site, pregnant women, patients with life-expectancy of < 1 year or patients who are currently involved in another study for peritoneal dialysis catheter exit site care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Hydrocolloid Dressing for Peritoneal Dialysis Catheter Exit Site Care in Peritoneal Dialysis Patients - a Pilot Study
The study aims to examine the use of hydrocolloid dressing for catheter exit-site care in peritoneal dialysis patients. It is a pilot study, and participants will be randomized to either receiving weekly hydrocolloid dressing or daily topical gentamicin cream for exit-site care in peritoneal dialysis patients.
Read the detailed description
Peritoneal dialysis (PD) related infection is one of the main reasons for patients to discontinue PD therapy. Routine exit-site care is crucial for the prevention of infections, however, daily antibiotics use has been associated with the risk of developing drug-resistant bacteria. Moreover, the burden of daily exit-site care can lead to non-compliance with treatment. Hydrocolloid dressing has been used in the management of acute and chronic wounds and is required to change once weekly, but its use has not been examined in the exit-site wound in PD patients.
The study primarily aims to examine PD-related infection (exit site infection or peritonitis rates) between patients using weekly hydrocolloid dressing (experimental group) and those using daily topical application of gentamicin (control group) for exit-site care in PD patients. Secondary aims include time to the first episode of PD-related infection, technique failure, PD infection-related hospitalization, and adverse events. The study will also assess the acceptability of dressing and quality of life between the two groups.
A total of 60 adult peritoneal dialysis patients will be recruited for the study. Patients will be randomly assigned to either the experimental group or the control group. Participants will be followed up at the 4th, 12th, and 24th week of study. The acceptability of the dressing will be assessed using the treatment acceptability questionnaires. The quality of life will be assessed using the ED 5D-5L questionnaires.
- Being tested
- hydrocolloid dressing, Gentamicin Sulfate, Topical
- Keywords
- peritoneal dialysis, exit-site care, exit-site dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocolloid dressingDevice
Duoderm Extra Thin hydrocolloid dressing will be used to cover the catheter exit-site of participants in the intervention group. The dressing will be changed every 7 days or early if the dressing is no longer adhesive.
Gentamicin Sulfate, TopicalDrug
Application of gentamicin to exit site daily
| Study group | Role | What they receive |
|---|---|---|
| Hydrocolloid dressing | Experimental | The intervention group will use the weekly hydrocolloid dressing (Duoderm Extra Thin CGF dressing,10 x 10 cm) for peritoneal dialysis exit-site care Receives: Device: hydrocolloid dressing |
| Gentamicin cream | Active comparator | The control group will apply topical gentamicin cream to catheter exit site daily and cover with normal dressing Receives: Drug: Gentamicin Sulfate, Topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritoneal dialysis (PD)-related infection rate
PD-related infection (exit-site /tunnel infection or peritonitis) (episode per patient-year)
Measured: 24 weeks
Secondary outcomes (6)
Time to the first episode of exit-site/tunnel infection or peritonitis
Time to first episode of exit-site/tunnel infection or peritonitis (days)
Measured: 24 weeks
Peritoneal dialysis infection-related hospitalization rate
Hospitalization due to peritoneal dialysis-related infection (episode per patient-year)
Measured: 24 weeks
Technique failure rate
Technique failure is defined as transfer to hemodialysis for >= 30 days (episode per patient-year)
Measured: 24 weeks
Adverse events
Adverse events related to the dressing (local or systemic effects)
Measured: 24 weeks
Quality of life score using ED 5D 5L questionnaire
Quality of life score using ED 5D 5L questionnaire (numerical scores)
Measured: at 12th week of study
Treatment acceptability
Acceptability of dressing will be measured by treatment acceptability questionnaire
Measured: at 12th week of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start11 Mar 2022
- Primary completion30 Jul 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis Catheter Exit Site InfectionStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143164
- Sponsor's protocol ID
- 2021/2434
- Status last verified
- May 2026
- First submitted
- 22 Nov 2021
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Hydrocolloid Dressing for Peritoneal Dialysis Catheter Exit Site Care in Peritoneal Dialysis Patients - a Pilot Study
- ClinicalTrials.gov ID
- NCT05143164
- Acronym / sponsor ID
- 2021/2434
- Keywords
- peritoneal dialysis, exit-site care, exit-site dressing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 3 Dec 2021 (actual)
- 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.
The study aims to examine the use of hydrocolloid dressing for catheter exit-site care in peritoneal dialysis patients. It is a pilot study, and participants will be randomized to either receiving weekly hydrocolloid dressing or daily topical gentamicin cream for exit-site care in peritoneal dialysis patients.
Detailed description
Peritoneal dialysis (PD) related infection is one of the main reasons for patients to discontinue PD therapy. Routine exit-site care is crucial for the prevention of infections, however, daily antibiotics use has been associated with the risk of developing drug-resistant bacteria. Moreover, the burden of daily exit-site care can lead to non-compliance with treatment. Hydrocolloid dressing has been used in the management of acute and chronic wounds and is required to change once weekly, but its use has not been examined in the exit-site wound in PD patients.
The study primarily aims to examine PD-related infection (exit site infection or peritonitis rates) between patients using weekly hydrocolloid dressing (experimental group) and those using daily topical application of gentamicin (control group) for exit-site care in PD patients. Secondary aims include time to the first episode of PD-related infection, technique failure, PD infection-related hospitalization, and adverse events. The study will also assess the acceptability of dressing and quality of life between the two groups.
A total of 60 adult peritoneal dialysis patients will be recruited for the study. Patients will be randomly assigned to either the experimental group or the control group. Participants will be followed up at the 4th, 12th, and 24th week of study. The acceptability of the dressing will be assessed using the treatment acceptability questionnaires. The quality of life will be assessed using the ED 5D-5L questionnaires.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Hydrocolloid dressing | Experimental | Device: hydrocolloid dressingThe intervention group will use the weekly hydrocolloid dressing (Duoderm Extra Thin CGF dressing,10 x 10 cm) for peritoneal dialysis exit-site care |
| Gentamicin cream | Active comparator | Drug: Gentamicin Sulfate, TopicalThe control group will apply topical gentamicin cream to catheter exit site daily and cover with normal dressing |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult peritoneal dialysis patients (≥ 21 years old) and are followed up at Singapore General Hospital (SGH)
Key exclusion criteria (1 listed)
- Patients who are unable to provide valid consent, patients who have known allergy to hydrocolloid dressing, patients who have peritoneal dialysis catheter exit site infection or peritonitis within the past 3 months, patients who have dialysate leak at PD catheter exit site, pregnant women, patients with life-expectancy of < 1 year or patients who are currently involved in another study for peritoneal dialysis catheter exit site care.
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 |
|---|---|---|
| hydrocolloid dressingDuoderm Extra Thin hydrocolloid dressing will be used to cover the catheter exit-site of participants in the intervention group. The dressing will be changed every 7 days or early if the dressing is no longer adhesive. | Device | Hydrocolloid dressing |
| Gentamicin Sulfate, TopicalApplication of gentamicin to exit site daily | Drug | Gentamicin cream |
Primary outcome
Peritoneal dialysis (PD)-related infection rate
Time frame: 24 weeks
PD-related infection (exit-site /tunnel infection or peritonitis) (episode per patient-year)
6 secondary outcomes
Time to the first episode of exit-site/tunnel infection or peritonitis
Time frame: 24 weeks
Peritoneal dialysis infection-related hospitalization rate
Time frame: 24 weeks
Technique failure rate
Time frame: 24 weeks
Adverse events
Time frame: 24 weeks
Quality of life score using ED 5D 5L questionnaire
Time frame: at 12th week of study
Treatment acceptability
Time frame: at 12th week of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
Related trials for Peritoneal Dialysis Catheter Exit Site Infection
Not yet recruiting
Silver-Impregnated Dressings for Catheter Exit-Site and Tunnel Infections in Peritoneal Dialysis Patients
Peritoneal Dialysis Catheter Exit Site Infection, Peritoneal Dialysis Catheter Tunnel Infection
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydrocolloid dressing and Gentamicin Sulfate, Topical in people with Peritoneal Dialysis Catheter Exit Site Infection, run by Singapore General Hospital at 1 site in Singapore.
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 1 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: finished, as of the sponsor's last update on 8 May 2026. 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 Singapore. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peritoneal dialysis (PD)-related infection rate (time frame: 24 weeks). 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 8 May 2026.