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| ID | Type | Description | Link |
|---|---|---|---|
| GHETRREN0000 | Other Grant/Funding Number | Singapore General Hospital Department of Renal Medicine Education, Training and Research Fund (ETRF) |
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The goal of this clinical trial is to evaluate the feasibility and acceptability of using silver-impregnated dressings, compared to standard daily topical antibiotic exit-site dressings, for the management of catheter exit-site infection or tunnel infection in adult patients undergoing peritoneal dialysis. The study also aims to explore infection resolution, safety, and clinical outcomes associated with this alternative exit-site care approach.
The main questions it aims to answer are:
Is the use of silver-impregnated dressings feasible and acceptable for peritoneal dialysis patients with exit-site or tunnel infection? Does the use of silver-impregnated dressings result in faster resolution of catheter exit-site or tunnel infection? Does replacing daily topical antibiotic dressings with silver-impregnated dressings reduce the frequency of dressing changes and the time spent on exit-site care? Are there any adverse events associated with the use of silver-impregnated dressings? What infection-related clinical outcomes occur, including recurrence of infection, need for catheter removal, or infection-related hospitalisation?
Standard management of catheter exit-site or tunnel infection typically includes daily exit-site cleansing, application of topical antibiotics, sterile dressing coverage, and systemic antibiotic therapy. Despite these treatments, some patients continue to experience persistent or recurrent infections and adverse outcomes such as peritonitis, catheter loss, or transfer to haemodialysis.
Participants will:
Be randomly assigned to receive either silver-impregnated dressings or standard exit-site care with daily topical antibiotic dressings as alternative approaches to local exit-site management Continue to receive systemic antibiotics according to current clinical guidelines Attend regular clinic visits for exit-site assessment and monitoring Be followed for up to twelve weeks to evaluate feasibility, safety, patient experience, and infection-related outcomes
The results of this pilot study will help evaluate whether silver-impregnated dressings are a feasible and acceptable alternative to standard topical antibiotic exit-site dressings for managing catheter-related infections in peritoneal dialysis patients and will inform the design of future larger clinical studies.
Catheter exit-site infection (ESI) and tunnel infection (TI) are significant complications in patients undergoing peritoneal dialysis (PD) and remain important contributors to peritonitis, catheter loss, technique failure, and unplanned transition to haemodialysis. These complications negatively impact patient outcomes and confidence in PD as a long-term renal replacement therapy.
Current guideline-recommended management of catheter exit-site and tunnel infection includes daily exit-site cleansing with antiseptic agents, application of topical antibiotics (such as gentamicin or mupirocin), sterile dressing coverage, and systemic antibiotic therapy guided by microbiological results. Despite adherence to these measures, catheter-related infections continue to occur, and a substantial proportion of patients experience persistent or recurrent infection, catheter trauma from frequent manipulation, local skin irritation, or delayed wound healing.
Silver-impregnated dressings have been widely used in acute and chronic wound management because of their sustained broad-spectrum antimicrobial activity. Silver ions act through multiple mechanisms, including disruption of bacterial cell membranes, interference with enzymatic activity and DNA replication, and inhibition of biofilm formation. These mechanisms reduce microbial burden and may lower the risk of antimicrobial resistance associated with prolonged topical antibiotic exposure. Silver dressings provide continuous antimicrobial coverage over several days and may reduce the need for frequent dressing changes and repeated catheter manipulation. These properties support their potential role as an alternative approach to local exit-site management during active catheter-related infection.
This study is designed as a prospective, single-centre, pilot, randomised controlled trial to evaluate the feasibility and acceptability of using silver-impregnated dressings in place of standard daily topical antibiotic exit-site dressings for the management of catheter exit-site infection or tunnel infection in adult PD patients. The study also explores infection resolution, safety, and catheter-related clinical outcomes associated with this alternative exit-site care strategy.
A total of 60 adult participants with clinically diagnosed exit-site infection or tunnel infection will be recruited from the Singapore General Hospital Peritoneal Dialysis Programme, including both inpatient and outpatient settings. Eligible participants will be randomly assigned in a 1:1 ratio to one of two study arms: (1) silver-impregnated dressing for exit-site care, or (2) standard exit-site care with daily topical antibiotic dressing. Randomisation will be computer-generated and performed without stratification. The study is open-label, as blinding of participants and investigators is not feasible due to the nature of the interventions.
All participants will continue to receive systemic antibiotic therapy for exit-site or tunnel infection according to current institutional practice and clinical guidelines. The assigned dressing intervention applies only to local exit-site management.
Participants assigned to the silver-impregnated dressing arm will receive exit-site care using a silver-based dressing applied in accordance with manufacturer instructions and the study protocol. Exit-site cleansing will be performed using non-iodine-based antiseptic agents to avoid interference with the antimicrobial properties of silver. Dressing-change frequency will be guided by clinical assessment of exudate and infection status and is expected to be less frequent than daily dressing changes during active infection.
Participants assigned to the standard care arm will receive routine institutional exit-site care, consisting of antiseptic exit-site cleansing, application of topical antibiotic ointment, and coverage with a standard dressing. Dressing changes in this group will be performed daily or as required according to usual clinical practice.
Participants will be followed for up to twelve weeks, corresponding to the period of active infection management and early recovery. Scheduled follow-up visits will include routine exit-site assessment, documentation of infection status, and monitoring for adverse events. These visits are aligned with standard clinical follow-up to minimise additional participant burden. Infection resolution, recurrence, and catheter-related outcomes will be assessed through clinical evaluation and review of medical records.
Feasibility outcomes include the ability to recruit and retain participants, adherence to the assigned dressing protocol, and completion of scheduled visits. Acceptability will be assessed using participant-reported experience measures addressing comfort, usability, and satisfaction with the assigned exit-site dressing. Safety assessments include monitoring for dressing-related adverse events such as local skin irritation, hypersensitivity reactions, or other complications.
As a pilot study, this trial is not powered to detect definitive differences in clinical efficacy. Rather, it is intended to generate preliminary data on feasibility, safety, adherence, and patient acceptability of silver-impregnated dressings as an alternative to standard daily topical antibiotic exit-site care. The findings will inform the design and planning of future larger, adequately powered studies to evaluate clinical effectiveness, long-term outcomes, and cost-effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Silver-Impregnated Dressing | Experimental | Participants assigned to this arm will receive peritoneal dialysis catheter exit-site management using a silver-impregnated dressing as an alternative to standard daily topical antibiotic dressing for the treatment of exit-site or tunnel infection. The exit site will be cleaned with an appropriate antiseptic solution prior to dressing application. Dressing changes will be performed at intervals guided by clinical assessment of exudate and infection status and are expected to be less frequent than daily changes during active infection. Participants will continue to receive systemic antibiotic therapy according to institutional practice and clinical guidelines. |
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| 2. Standard exit-site care with topical antibiotics | Active Comparator | Participants assigned to this arm will receive standard institutional peritoneal dialysis catheter exit-site care for the management of exit-site or tunnel infection. Exit-site care includes cleansing with antiseptic agents, application of topical antibiotic ointment (such as gentamicin or mupirocin), and coverage with a standard dressing. Dressing changes are performed daily according to usual clinical practice. Systemic antibiotic therapy for exit-site or tunnel infection is continued in accordance with institutional protocols and clinical guidelines. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silver-Impregnated Dressing | Device | A silver-impregnated dressing being evaluated for the management of peritoneal dialysis catheter exit-site or tunnel infection. The dressing provides antimicrobial activity through the presence of silver ions and will be applied to the catheter exit site following routine cleansing with an appropriate antiseptic solution. Dressing-change frequency will be guided by clinical assessment of exudate and infection status and is generally less frequent than daily changes during active infection. The silver-impregnated dressing is used as an alternative to standard daily topical antibiotic exit-site dressings as part of local exit-site care. Participants will continue to receive systemic antibiotic therapy according to institutional practice and clinical guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of eligible patients enrolled into the study | Recruitment feasibility assessed as the proportion of eligible patients approached for study participation who provide written informed consent and are enrolled into the study. | From study initiation until completion of enrolment (approximately 4-6 months) |
| Proportion of enrolled participants completing 12 week follow up | Retention feasibility assessed as the proportion of enrolled participants in both the silver impregnated dressing arm and the standard exit site care arm who complete all scheduled study follow up visits through the 12 week follow up period, based on study attendance records. A higher proportion indicates greater participant retention during the study period. | From enrolment to completion of 12 week follow up period |
| Proportion of scheduled dressing changes completed according to assigned protocol | Protocol adherence assessed as the proportion of scheduled dressing applications and dressing changes completed according to the assigned study intervention during the 12 week follow up period, based on study documentation and clinical records. A higher proportion indicates greater adherence to the assigned dressing protocol. | From enrolment to completion of 12 week follow up period |
| Measure | Description | Time Frame |
|---|---|---|
| Participant reported acceptability of assigned dressing intervention | Acceptability assessed at Week 6 using a participant-reported treatment acceptability questionnaire evaluating overall acceptability, perceived effectiveness, likelihood of negative side effects, and trustworthiness of the assigned dressing intervention, with responses measured on a 7-point Likert scale. | At 6 weeks following enrolment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khin Zar Li Lwin, MBBS, MRCP(UK) | Contact | 65-96303455 | khin.zar.l.l@singhealth.com.sg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore General Hospital | Singapore | 169608 | Singapore |
No decision has been made regarding sharing of de-identified participant data. Any future data sharing will be subject to institutional policies, ethical considerations, and available resources.
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Participants are randomly assigned in a 1:1 ratio to one of two parallel arms: silver-impregnated dressing or standard exit-site care with daily topical antibiotic dressing. Each participant receives the assigned local exit-site management throughout the study period.
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| Standard Exit-Site Care With Topical Antibiotic Dressing | Device | This intervention consists of standard institutional peritoneal dialysis catheter exit-site care for the management of exit-site or tunnel infection. Exit-site care includes routine cleansing with antiseptic agents, application of topical antibiotic ointment (such as gentamicin or mupirocin), and coverage with a standard dressing. Dressing changes are performed daily or as required according to usual clinical practice. This intervention represents standard care and serves as the comparator for evaluating the feasibility of the silver-impregnated dressing. Systemic antibiotic therapy, is provided according to institutional practice and clinical guidelines. |
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| Time to clinical resolution of catheter exit site or tunnel infection | Time from randomisation to clinical resolution of catheter exit site infection (ESI) or tunnel infection, assessed to evaluate whether silver dressing use accelerates infection resolution compared with standard dressing care. Clinical resolution will be determined by investigator assessment of resolution of local signs and symptoms of infection, including erythema, tenderness, swelling, and purulent discharge. | Up to 6 weeks following randomisation |
| Number of participants with dressing related adverse events | Safety assessed by the occurrence of dressing-related adverse events, including local skin irritation or hypersensitivity reactions documented during the study period. | Up to 12 weeks following randomisation. |
| Occurrence of infection related clinical outcomes | Infection-related clinical outcomes assessed by the occurrence of recurrent catheter exit site infection or tunnel infection, progression to peritonitis, catheter removal due to infection, infection-related hospitalisation, or infection-related death during the study period. | Up to 12 weeks following randomisation. |