Peritoneal Dialysis Catheter Exit Site InfectionNCT03406520
Chlorhexidine Disk for Prevention of Exit-site Infection in Peritoneal Dialysis Patients
A study testing Chlorhexidine-impregnated disk in people with Peritoneal Dialysis Catheter Exit Site Infection, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of chlorhexidine-impregnated disk in preventing catheter exit-site infection in peritoneal dialysis patients Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Peritoneal Dialysis Catheter Exit Site Infection
- What is being tested?
- Chlorhexidine-impregnated disk
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 7 Mar 2018to 25 Oct 2019
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult incident peritoneal dialysis patients between 21 to 90 years old, who are followed up in Singapore General Hospital
Who cannot join
- patients who have known history of allergy to chlorhexidine
- patients who had previous history of peritoneal dialysis catheter exit-site infection
- patients with mentally challenging conditions who are unable to give the valid consent for the study
- patients who have been involved in another study for exit site infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chlorhexidine-impregnated Sponge Dressing for Prevention of Catheter Exit Site Infection in Incident Peritoneal Dialysis Patients - a Pilot Study
The purpose of the study is to evaluate the efficacy and safety of chlorhexidine-impregnated disk in preventing catheter exit-site infection in peritoneal dialysis patients
Read the detailed description
The primary aim of the study is to examine the exit-site infection rate in patients using chlorhexidine-impregnated dressing.
The participant will be followed up at 2, 6, 12, 24, 36 and 52 weeks of study and during each visit the catheter exit-site will be examined by one of the investigators for any sign of infection or allergic reaction, and questionnaires about satisfaction with use of study material (biopatch) will be asked by a study team member at the 12 week visit of the study. Each participant will be followed up for one year.
- Being tested
- Chlorhexidine-impregnated disk
- Keywords
- peritoneal dialysis, chlorhexidine, exit site infection, tunnel tract infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine-impregnated diskDevice
Also called biopatch disk
The chlorhexidine-impregnated sponge, named biopatch, is a protective disk (2.5 cm x 0.7 cm), which is hydrophilic polyurethane absorptive foam with chlorhexidine gluconate, in average of 86.8mg per disk
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine-impregnated disk | Experimental | The chlorhexidine-impregnated disk, will be applied to the peritoneal dialysis catheter exit-site and the disk will be changed once a week Receives: Device: Chlorhexidine-impregnated disk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exit-site/tunnel infection rate
Exit-site/tunnel infection rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk
Measured: one year
Secondary outcomes (9)
Time to the first episode of exit-site/tunnel infection
days from peritoneal dialysis initiation to the time develops first exit-site/tunnel infection
Measured: one year
peritonitis rate
Peritonitis rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk
Measured: one year
time to first episode of peritonitis
days from peritoneal dialysis initiation to the time develops first episode of peritonitis
Measured: one year
Peritoneal dialysis infection-related hospitalization
Hospitalization due to peritoneal dialysis-related infection
Measured: one year
technique failure rate
technique failure is defined as transfer to hemodialysis for >= 30 days
Measured: one year
adverse events
any local or systemic adverse events
Measured: one year
mortality
all-cause mortality
Measured: one year
patient satisfaction with the use of chlorhexidine-impregnated sponge dressing
Questionnaires related to the treatment with chlorhexidine-impregnated disk
Measured: third month of study
comparison of the above outcomes with historical cohort using topical antibiotics cream
comparison of exit-site/tunnel infection rate, peritonitis rate, time to first episode of exit-site/tunnel infection or peritonitis, technique failure rate, hospitalization rate, adverse events, mortality with historical cohort patients using topical gentamicin cream
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start7 Mar 2018
- Primary completion1 Oct 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Htay Htay, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406520
- Sponsor's protocol ID
- SRG-NIG#08/2017
- Status last verified
- Mar 2020
- First submitted
- 14 Jan 2018
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Htay H, Choo JCJ, Johnson DW, Pascoe EM, Jayaballa M, Oei EL, Ng LC, Wu SY, Foo MWY. Chlorhexidine-impregnated sponge dressing for prevention of catheter exit-site infection in peritoneal dialysis patients: a pilot study. Int Urol Nephrol. 2021 Apr;53(4):803-812. doi: 10.1007/s11255-020-02674-w. Epub 2020 Oct 6.
PubMed 33025409
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlorhexidine-impregnated Sponge Dressing for Prevention of Catheter Exit Site Infection in Incident Peritoneal Dialysis Patients - a Pilot Study
- ClinicalTrials.gov ID
- NCT03406520
- Acronym / sponsor ID
- SRG-NIG#08/2017
- Keywords
- peritoneal dialysis, chlorhexidine, exit site infection, tunnel tract infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 23 Jan 2018 (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 purpose of the study is to evaluate the efficacy and safety of chlorhexidine-impregnated disk in preventing catheter exit-site infection in peritoneal dialysis patients
Detailed description
The primary aim of the study is to examine the exit-site infection rate in patients using chlorhexidine-impregnated dressing.
The participant will be followed up at 2, 6, 12, 24, 36 and 52 weeks of study and during each visit the catheter exit-site will be examined by one of the investigators for any sign of infection or allergic reaction, and questionnaires about satisfaction with use of study material (biopatch) will be asked by a study team member at the 12 week visit of the study. Each participant will be followed up for one year.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine-impregnated disk | Experimental | Device: Chlorhexidine-impregnated diskThe chlorhexidine-impregnated disk, will be applied to the peritoneal dialysis catheter exit-site and the disk will be changed once a week |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult incident peritoneal dialysis patients between 21 to 90 years old, who are followed up in Singapore General Hospital
Key exclusion criteria (4 listed)
- patients who have known history of allergy to chlorhexidine
- patients who had previous history of peritoneal dialysis catheter exit-site infection
- patients with mentally challenging conditions who are unable to give the valid consent for the study
- patients who have been involved in another study for exit site infection
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 |
|---|---|---|
| Chlorhexidine-impregnated diskAlso: biopatch diskThe chlorhexidine-impregnated sponge, named biopatch, is a protective disk (2.5 cm x 0.7 cm), which is hydrophilic polyurethane absorptive foam with chlorhexidine gluconate, in average of 86.8mg per disk | Device | Chlorhexidine-impregnated disk |
Primary outcome
Exit-site/tunnel infection rate
Time frame: one year
Exit-site/tunnel infection rate (reported as episodes per patient-year) in patients receiving chlorhexidine-impregnated disk
9 secondary outcomes
Time to the first episode of exit-site/tunnel infection
Time frame: one year
peritonitis rate
Time frame: one year
time to first episode of peritonitis
Time frame: one year
Peritoneal dialysis infection-related hospitalization
Time frame: one year
technique failure rate
Time frame: one year
adverse events
Time frame: one year
mortality
Time frame: one year
patient satisfaction with the use of chlorhexidine-impregnated sponge dressing
Time frame: third month of study
comparison of the above outcomes with historical cohort using topical antibiotics cream
Time frame: one year
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 23 Mar 2020.
- Derived from this study: PubMed 33025409Htay H, Choo JCJ, Johnson DW, Pascoe EM, Jayaballa M, Oei EL, Ng LC, Wu SY, Foo MWY. Chlorhexidine-impregnated sponge dressing for prevention of catheter exit-site infection in peritoneal dialysis patients: a pilot study. Int Urol Nephrol. 2021 Apr;53(4):803-812. doi: 10.1007/s11255-020-02674-w. Epub 2020 Oct 6.
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.
Htay Htay principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine-impregnated disk 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 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: finished, as of the sponsor's last update on 23 Mar 2020. 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?
Exit-site/tunnel infection rate (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03406520, which also lists 1 linked publication.
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 23 Mar 2020.