Silver-Impregnated Dressings for Catheter Exit-Site and Tunnel Infections in Peritoneal Dialysis Patients

NCT07641491 | Not Yet Recruiting

• 2 other identifiers: ECOS 2026-0585GHETRREN0000
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peritoneal Dialysis Catheter Exit Site Infection; Peritoneal Dialysis Catheter Tunnel Infection

Keywords

peritoneal dialysis; exit-site infection; tunnel infection; standard exit-site care; silver-impregnated dressings

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• Participant reported acceptability of assigned dressing intervention

  At 6 weeks following enrolment.

• Time to clinical resolution of catheter exit site or tunnel infection

  Up to 6 weeks following randomisation

• Number of participants with dressing related adverse events

  Up to 12 weeks following randomisation.

• Occurrence of infection related clinical outcomes

  Up to 12 weeks following randomisation.

Study Arms (2)

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.

Device: Silver-Impregnated Dressing

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.

Device: Standard Exit-Site Care With Topical Antibiotic Dressing

Interventions

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.

1. Silver-Impregnated Dressing

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.

2. Standard exit-site care with topical antibiotics

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 21 to 90 years
• Currently receiving peritoneal dialysis under the Singapore General Hospital Peritoneal Dialysis Programme
• Diagnosed with an active catheter exit-site infection or tunnel infection based on standard clinical criteria

You may not qualify if:

• Known allergy or sensitivity to silver dressings
• Pregnant
• Expected life expectancy of less than 6 months
• Unable to provide informed consent
• Currently participating in another clinical study involving exit-site care or wound dressings
• Planned removal of the peritoneal dialysis catheter within the next 7 days

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Central Study Contacts

Khin Zar Li Lwin, MBBS, MRCP(UK)

CONTACT

65-96303455; khin.zar.l.l@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-05

Locations

SG (1)