Peritoneal Dialysis Catheter Exit Site InfectionNCT06022835
Chlorhexidine Gluconate-gel Dressing for Exit Site Infection in Peritoneal Dialysis
A study testing Chlorhexidine Gluconate-gel (CHG) Dressing in people with Peritoneal Dialysis Catheter Exit Site Infection and End Stage Renal Disease on Dialysis, run by National Healthcare Group, Singapore at 1 site in Singapore.
Trial summary
Exit site infection (ESI) is one of the major predisposing factors to peritoneal dialysis (PD) related peritonitis. Chlorhexidine Gluconate (CHG) has been widely used for cutaneous disinfection for half a century. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Peritoneal Dialysis Catheter Exit Site Infection, End Stage Renal Disease on Dialysis, Dialysis; Complications
- What is being tested?
- Chlorhexidine Gluconate-gel (CHG) Dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- 27 Sep 2019to 31 Jul 2023
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All incident PD patients
Who cannot join
- Patients allergic to chlorhexidine and Tegaderm dressing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tegaderm(TM) Chlorhexidine Gluconate-gel (CHG) Dressing for the Prevention of Exit Site Infection in Patients Receiving Peritoneal Dialysis.
Exit site infection (ESI) is one of the major predisposing factors to peritoneal dialysis (PD) related peritonitis. Chlorhexidine Gluconate (CHG) has been widely used for cutaneous disinfection for half a century. TegadermTM CHG is a water-proof dressing with gel pads that provide 2% CHG to the skin surface and effectively prevents catheter-related infections for intravascular catheters. However, its use has not been accessed in patients with PD catheters. We aim to evaluate the effectiveness of TegadermTM CHG dressing in preventing ESI in PD patients.
Read the detailed description
Peritoneal Dialysis (PD) is one of the common therapies for patients with End Stage Renal Failure (ESRF). As the global burden of chronic kidney disease continues to increase, so does the need for a cost-effective renal replacement therapy (1). Patient outcomes with peritoneal dialysis are comparable to or better than those with haemodialysis, and peritoneal dialysis is also more cost-effective (1). It is reported that PD improves patient's well-being and has greater personal freedom as compared to Hemodialysis through less restrictive life-style changes (2). All dialysis treatments include a certain risk of infection because of the decreased immune defenses of patients in established renal failure (ERF) and because dialysis techniques increase the potential of microbial contamination (3).
PD is associated with a high risk of infection of the peritoneum, subcutaneous tunnel and catheter exit site (4). ESI is diagnosed by the presence of purulent drainage, with or without erythema of the skin at the catheter-epidermal interface (5). Exit site infection (ESI) increases the possibility of developing PD peritonitis which demands careful attendance to these problems. It is estimated that 12% of cases of ESI results in PD peritonitis (6). As many as 15%-50% of ESRF patients are on PD, but recurrent or prolonged peritonitis may causes technique failure in PD (3). The majority of catheter related problems are of an infection nature - mainly represented by peritonitis (61%); ESI (23%); catheter obstruction, dislocation and leakage making up the rest (3). Peritonitis can be associated with severe pain leading to hospitalisation, catheter loss, and a risk of death; and it therefore continues to be a serious complication for PD patients (7).
There are no recommendations what topical care of the PD catheter exit site is optimal. Several methods including Povidone-Iodine, hydrogen peroxide, chlorhexidine, soap and water, and topical creams such as gentamicin or mupirocin cream have been studied for exit site care (8,9).
A number of topical cleansing agents have been studied for prevention of catheter-related infections however no cleansing agent has shown to be superior with respect to preventing catheter-related infections (5). The International Society for Peritoneal Dialysis (ISPD) recommends the use of daily topical application of antibiotic cream or ointment to the catheter exit site to prevent infection and exit site be cleansed at least twice weekly and every time after a shower (5).
Appropriate care of the exit site will avoid loss of catheter and unnecessary dialysis modality change. PD-related infection is the most common cause of technique failure. Prevention and treatment of PD catheter related infection such as peritonitis and exit site infections are important to maintain on PD therapy.
In Khoo Teck Puat Hospital (KTPH) we had been following the ISPD guidelines on the dressing recommendation to use iodine as the preferred cleansing agent and application of Gentamicin cream 0.1% as prophylaxis to prevent PD exit site infection. However, we had noticed an increase in patient's risk of PD ESI from 2016 0.15/year at risk, 2017 0.19/year at risk and 2018 0.22/year at risk. Of which 40-55% were gram positive infections, 5-15% were gram negative infections and the rest were having no bacterial cultures or fungal infections. We evaluated on the infection episodes and reassessed on patients technique and home environment and found that reasons of infection were due to poor compliance to dressing techniques, frequency of change after shower, hand washing technique and home environment cleanliness.
Several research articles were reviewed and Chlorhexidine Gluconate (CHG) was found to be used widely throughout the world for more than 50 years for cutaneous disinfection, hand hygiene and oral hygiene, and the safety of CHG is well established (10).Clinically relevant high-level bacterial resistance has been very rare (11).
TegadermTM CHG Dressing had a gel pad that provides 2% CHG to the skin surface. It was proven to largely reduce catheter-related bloodstream infections (CRBSI) (from 1.21 to 0.28 per 1000 catheter days) and vascular catheter colonization (12). The CHG dressing is recommended to be worn up to 7days and provide CHG antimicrobial protection, secure adhesion, gentle removal, site visibility, breathability and patient comfort (13).
Unlike CRBSI, TegadermTM CHG Dressing was not evaluated for its effectiveness in prevention of exit infection in PD patients. This would be the first study to evaluate the effectiveness of TegadermTM CHG Dressing in reducing peritoneal dialysis catheter exit site infection. The ease of application of the dressing will help to increase patients and caregivers' compliance as the frequency of change was reduced from daily to once every 7 days. TegadermTM CHG dressing also water-proof and it will helps in maintaining the exit site clean and dry. By reducing the PD ESI rates, it will also helps in preventing secondary peritonitis and prevents unnecessary dialysis modality changes.
This would be the first study to evaluate the effectiveness of Tegaderm™ chlorhexidine gluconate-gel (CHG) dressing for the prevention of exit site infection in patient receiving peritoneal dialysis.
Participants will use Tegaderm™ chlorhexidine gluconate-gel (CHG) dressing for a period of 4-6months. Results will be compared with historical data from 1st Nov 2016 to 31st Oct 2017. Estimated 40 patient's historical data will be reviewed.
New Method:
Patients are taught to perform 7 steps handwashing, clean PD exit site with chlorhexidine swab sticks, dry with gauze, and apply TegadermTM CHG Dressing. This has to be repeated every 7days or when the dressing is soiled.
Old Method:
Patients are taught to perform 7 steps handwashing, clean PD exit site with 3 swab sticks, dry with gauze, apply Gentamicin cream 0.1% and cover with soft cloth dressing. This has to be repeated daily after shower or when the dressing is soiled.
References
- Kam TL, Chow KM, Luijtaarden M, Johnson DW, Jager KJ, Mehrotra, JR, Naicker, S, Pecoits-Filho R, Yu XQ, Lameire N: Changes in the worldwide epidemiology of peritoneal dialysis. Nature Reviews Nephrology, 13:90-109-3, 2017
- Lockwood C, Hodgkinson B, Page T: Clinical effectiveness of different approaches to peritoneal dialysis catheter exit-site care. JBI Reports, 1(6): 167-201, 2003
- Akoh JA: Peritoneal dialysis associated infections: An update on diagnosis and management. World Journal of Nephrology, 1(4):106-122, 2012
- Bianchi P, Buoncristiani E, Buoncristiani U: Antisepsis. Contrib Nephrol 154: 1-6, 2007
- Szeto CC, Kam TL, Johnson DW, Bernardini J, Dong J, Figueiredo AE, Ito Y, Kazancioglu R, Moraes T, Esch SV, Brown EA: ISPD Catheter-related infection recommendations: 2017 Update. Perit Dial Int, 37: 141-154, 2007
- Brook NR, White SA, Waller JR, Nicholson ML: The surgical management of peritoneal dialysis catheters. Ann R Coll Surg Engl. 86: 190-195. 2004
- Campos RP, Chula DC, Riella MC: Complications of the peritoneal access and their management. Contrib Nephrol, 163: 183-197, 2009
- Ques AAM, Campo MV, Arribas CM, Marcos BB, Ramos CQ, del Barrio OR, Cortes MP, Marenco MT: Effectiveness of different types of care for the peritoneal dialysis catheter exit site: A systematic review. JBI Database of Systematic Reviews and Implementation Reports, 11(9):133-179, 2013
- McCormack K, Rabindranath K, Kilonzo M, Vale L, Fraser C, Mclntyre L, Thomas S, Rothnie H, Fluck N, Gould IM, Waugh N: Systematic review of the effectiveness of preventing and treating Staphylococcus aureus carriage in reducing peritoneal catheter-related infections. Health Technol Assess, 11(23):iii-iv, ix-x, 1-66, 2007
- Milstone AM. Passaretti CL. Perl TM. Chlorhexidine: expanding the armamentarium for infection control and prevention. Clin Infec Dis. 46:274-81, 2008
- McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev, 12(1): 147-79, 1999
- Righetti M, Palmieri N, Bracchi O, Prencipe M, Bruschetta E, Colombo F, et al.: Tegaderm CHG dressing significantly improves catheter-related infection rate in hemodialysis patients. The journal of vascular access, 17(5):417-22, 2016
- https://multimedia.3m.com/mws/media/501550O/tegaderm-chg-dressing-product-brochure.pdf
- Conditions
- Peritoneal Dialysis Catheter Exit Site Infection, End Stage Renal Disease on Dialysis, Dialysis; Complications
- Being tested
- Chlorhexidine Gluconate-gel (CHG) Dressing
- Keywords
- peritoneal dialysis, exit site infection, chlorhexidine, dressing, End stage renal disease
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine Gluconate-gel (CHG) DressingOther
Participants used Tegaderm™ CHG dressing for 4 months. The dressing was changed every seven days or soiled.
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine Gluconate-gel (CHG) Dressing group | Experimental | Participants used Tegaderm™ CHG dressing for 4 months. The dressing was changed every seven days or soiled. Receives: Other: Chlorhexidine Gluconate-gel (CHG) Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of exit site infection
the rate in patient months and by percentage
Measured: 12 weeks
Secondary outcomes (3)
time to first ESI and PD-associated peritonitis
Number of days patients have ESI/peritonitis-free survival
Measured: 12 weeks
PD-associated peritonitis
based on ISPD guidelines
Measured: 12 weeks
PD-related hospitalisation rate
hospitalisation rate in patient months
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start27 Sep 2019
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
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.
- 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
- The recruitment period was from October 2019 to August 2022. All incident PD patients aged between 21-99 years were screened. Patients allergic to chlorhexidine and Tegaderm dressing were excluded from the study. One hundred thirty-eight patients initiated PD and were screened between October 2019 and April 2022. A historical cohort of incident PD patients from November 2016 to October 2017 with the same inclusion and exclusion criteria were also recruited and compared to the CHG dressing group.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Healthcare Group, Singapore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Allen Liu Yan Lun, National Healthcare Group, Singapore
- Investigators
- Allen Yan Lun Liu, Study chair, Khoo Teck Puat Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022835
- Sponsor's protocol ID
- 2019/00493
- Other IDs
- 2019
- Status last verified
- Aug 2023
- First submitted
- 28 Aug 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tegaderm(TM) Chlorhexidine Gluconate-gel (CHG) Dressing for the Prevention of Exit Site Infection in Patients Receiving Peritoneal Dialysis.
- ClinicalTrials.gov ID
- NCT06022835
- Acronym / sponsor ID
- 2019/00493
- Conditions
- Peritoneal Dialysis Catheter Exit Site Infection, End Stage Renal Disease on Dialysis, Dialysis; Complications
- Keywords
- peritoneal dialysis, exit site infection, chlorhexidine, dressing, End stage renal disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Healthcare Group, SingaporeOther government
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 5 Sep 2023 (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.
Exit site infection (ESI) is one of the major predisposing factors to peritoneal dialysis (PD) related peritonitis. Chlorhexidine Gluconate (CHG) has been widely used for cutaneous disinfection for half a century. TegadermTM CHG is a water-proof dressing with gel pads that provide 2% CHG to the skin surface and effectively prevents catheter-related infections for intravascular catheters. However, its use has not been accessed in patients with PD catheters. We aim to evaluate the effectiveness of TegadermTM CHG dressing in preventing ESI in PD patients.
Detailed description
Peritoneal Dialysis (PD) is one of the common therapies for patients with End Stage Renal Failure (ESRF). As the global burden of chronic kidney disease continues to increase, so does the need for a cost-effective renal replacement therapy (1). Patient outcomes with peritoneal dialysis are comparable to or better than those with haemodialysis, and peritoneal dialysis is also more cost-effective (1). It is reported that PD improves patient's well-being and has greater personal freedom as compared to Hemodialysis through less restrictive life-style changes (2). All dialysis treatments include a certain risk of infection because of the decreased immune defenses of patients in established renal failure (ERF) and because dialysis techniques increase the potential of microbial contamination (3).
PD is associated with a high risk of infection of the peritoneum, subcutaneous tunnel and catheter exit site (4). ESI is diagnosed by the presence of purulent drainage, with or without erythema of the skin at the catheter-epidermal interface (5). Exit site infection (ESI) increases the possibility of developing PD peritonitis which demands careful attendance to these problems. It is estimated that 12% of cases of ESI results in PD peritonitis (6). As many as 15%-50% of ESRF patients are on PD, but recurrent or prolonged peritonitis may causes technique failure in PD (3). The majority of catheter related problems are of an infection nature - mainly represented by peritonitis (61%); ESI (23%); catheter obstruction, dislocation and leakage making up the rest (3). Peritonitis can be associated with severe pain leading to hospitalisation, catheter loss, and a risk of death; and it therefore continues to be a serious complication for PD patients (7).
There are no recommendations what topical care of the PD catheter exit site is optimal. Several methods including Povidone-Iodine, hydrogen peroxide, chlorhexidine, soap and water, and topical creams such as gentamicin or mupirocin cream have been studied for exit site care (8,9).
A number of topical cleansing agents have been studied for prevention of catheter-related infections however no cleansing agent has shown to be superior with respect to preventing catheter-related infections (5). The International Society for Peritoneal Dialysis (ISPD) recommends the use of daily topical application of antibiotic cream or ointment to the catheter exit site to prevent infection and exit site be cleansed at least twice weekly and every time after a shower (5).
Appropriate care of the exit site will avoid loss of catheter and unnecessary dialysis modality change. PD-related infection is the most common cause of technique failure. Prevention and treatment of PD catheter related infection such as peritonitis and exit site infections are important to maintain on PD therapy.
In Khoo Teck Puat Hospital (KTPH) we had been following the ISPD guidelines on the dressing recommendation to use iodine as the preferred cleansing agent and application of Gentamicin cream 0.1% as prophylaxis to prevent PD exit site infection. However, we had noticed an increase in patient's risk of PD ESI from 2016 0.15/year at risk, 2017 0.19/year at risk and 2018 0.22/year at risk. Of which 40-55% were gram positive infections, 5-15% were gram negative infections and the rest were having no bacterial cultures or fungal infections. We evaluated on the infection episodes and reassessed on patients technique and home environment and found that reasons of infection were due to poor compliance to dressing techniques, frequency of change after shower, hand washing technique and home environment cleanliness.
Several research articles were reviewed and Chlorhexidine Gluconate (CHG) was found to be used widely throughout the world for more than 50 years for cutaneous disinfection, hand hygiene and oral hygiene, and the safety of CHG is well established (10).Clinically relevant high-level bacterial resistance has been very rare (11).
TegadermTM CHG Dressing had a gel pad that provides 2% CHG to the skin surface. It was proven to largely reduce catheter-related bloodstream infections (CRBSI) (from 1.21 to 0.28 per 1000 catheter days) and vascular catheter colonization (12). The CHG dressing is recommended to be worn up to 7days and provide CHG antimicrobial protection, secure adhesion, gentle removal, site visibility, breathability and patient comfort (13).
Unlike CRBSI, TegadermTM CHG Dressing was not evaluated for its effectiveness in prevention of exit infection in PD patients. This would be the first study to evaluate the effectiveness of TegadermTM CHG Dressing in reducing peritoneal dialysis catheter exit site infection. The ease of application of the dressing will help to increase patients and caregivers' compliance as the frequency of change was reduced from daily to once every 7 days. TegadermTM CHG dressing also water-proof and it will helps in maintaining the exit site clean and dry. By reducing the PD ESI rates, it will also helps in preventing secondary peritonitis and prevents unnecessary dialysis modality changes.
This would be the first study to evaluate the effectiveness of Tegaderm™ chlorhexidine gluconate-gel (CHG) dressing for the prevention of exit site infection in patient receiving peritoneal dialysis.
Participants will use Tegaderm™ chlorhexidine gluconate-gel (CHG) dressing for a period of 4-6months. Results will be compared with historical data from 1st Nov 2016 to 31st Oct 2017. Estimated 40 patient's historical data will be reviewed.
New Method:
Patients are taught to perform 7 steps handwashing, clean PD exit site with chlorhexidine swab sticks, dry with gauze, and apply TegadermTM CHG Dressing. This has to be repeated every 7days or when the dressing is soiled.
Old Method:
Patients are taught to perform 7 steps handwashing, clean PD exit site with 3 swab sticks, dry with gauze, apply Gentamicin cream 0.1% and cover with soft cloth dressing. This has to be repeated daily after shower or when the dressing is soiled.
References
- Kam TL, Chow KM, Luijtaarden M, Johnson DW, Jager KJ, Mehrotra, JR, Naicker, S, Pecoits-Filho R, Yu XQ, Lameire N: Changes in the worldwide epidemiology of peritoneal dialysis. Nature Reviews Nephrology, 13:90-109-3, 2017
- Lockwood C, Hodgkinson B, Page T: Clinical effectiveness of different approaches to peritoneal dialysis catheter exit-site care. JBI Reports, 1(6): 167-201, 2003
- Akoh JA: Peritoneal dialysis associated infections: An update on diagnosis and management. World Journal of Nephrology, 1(4):106-122, 2012
- Bianchi P, Buoncristiani E, Buoncristiani U: Antisepsis. Contrib Nephrol 154: 1-6, 2007
- Szeto CC, Kam TL, Johnson DW, Bernardini J, Dong J, Figueiredo AE, Ito Y, Kazancioglu R, Moraes T, Esch SV, Brown EA: ISPD Catheter-related infection recommendations: 2017 Update. Perit Dial Int, 37: 141-154, 2007
- Brook NR, White SA, Waller JR, Nicholson ML: The surgical management of peritoneal dialysis catheters. Ann R Coll Surg Engl. 86: 190-195. 2004
- Campos RP, Chula DC, Riella MC: Complications of the peritoneal access and their management. Contrib Nephrol, 163: 183-197, 2009
- Ques AAM, Campo MV, Arribas CM, Marcos BB, Ramos CQ, del Barrio OR, Cortes MP, Marenco MT: Effectiveness of different types of care for the peritoneal dialysis catheter exit site: A systematic review. JBI Database of Systematic Reviews and Implementation Reports, 11(9):133-179, 2013
- McCormack K, Rabindranath K, Kilonzo M, Vale L, Fraser C, Mclntyre L, Thomas S, Rothnie H, Fluck N, Gould IM, Waugh N: Systematic review of the effectiveness of preventing and treating Staphylococcus aureus carriage in reducing peritoneal catheter-related infections. Health Technol Assess, 11(23):iii-iv, ix-x, 1-66, 2007
- Milstone AM. Passaretti CL. Perl TM. Chlorhexidine: expanding the armamentarium for infection control and prevention. Clin Infec Dis. 46:274-81, 2008
- McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev, 12(1): 147-79, 1999
- Righetti M, Palmieri N, Bracchi O, Prencipe M, Bruschetta E, Colombo F, et al.: Tegaderm CHG dressing significantly improves catheter-related infection rate in hemodialysis patients. The journal of vascular access, 17(5):417-22, 2016
- https://multimedia.3m.com/mws/media/501550O/tegaderm-chg-dressing-product-brochure.pdf
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The recruitment period was from October 2019 to August 2022. All incident PD patients aged between 21-99 years were screened. Patients allergic to chlorhexidine and Tegaderm dressing were excluded from the study. One hundred thirty-eight patients initiated PD and were screened between October 2019 and April 2022. A historical cohort of incident PD patients from November 2016 to October 2017 with the same inclusion and exclusion criteria were also recruited and compared to the CHG dressing group.
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine Gluconate-gel (CHG) Dressing group | Experimental | Other: Chlorhexidine Gluconate-gel (CHG) DressingParticipants used Tegaderm™ CHG dressing for 4 months. The dressing was changed every seven days or soiled. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All incident PD patients
Key exclusion criteria (1 listed)
- Patients allergic to chlorhexidine and Tegaderm dressing
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 Gluconate-gel (CHG) DressingParticipants used Tegaderm™ CHG dressing for 4 months. The dressing was changed every seven days or soiled. | Other | Chlorhexidine Gluconate-gel (CHG) Dressing group |
Primary outcome
The incidence rate of exit site infection
Time frame: 12 weeks
the rate in patient months and by percentage
3 secondary outcomes
time to first ESI and PD-associated peritonitis
Time frame: 12 weeks
PD-associated peritonitis
Time frame: 12 weeks
PD-related hospitalisation rate
Time frame: 12 weeks
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 5 Sep 2023.
- 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.
Allen Yan Lun Liu study chair
Khoo Teck Puat Hospital, Singapore
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 Gluconate-gel (CHG) Dressing in people with Peritoneal Dialysis Catheter Exit Site Infection and End Stage Renal Disease on Dialysis, run by National Healthcare Group, Singapore 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 5 Sep 2023. 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?
The incidence rate of exit site infection (time frame: 12 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 5 Sep 2023.