Chlorhexidine Gluconate-gel Dressing for Exit Site Infection in Peritoneal Dialysis

NCT06022835 | Completed

• 1 other identifier: 2019/00493
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• The incidence rate of exit site infection

  the rate in patient months and by percentage

  12 weeks

Secondary Outcomes (3)

• time to first ESI and PD-associated peritonitis

  12 weeks

• PD-associated peritonitis

  12 weeks

• PD-related hospitalisation rate

  12 weeks

Study Arms (1)

Chlorhexidine Gluconate-gel (CHG) Dressing group

EXPERIMENTAL

Participants used Tegaderm™ CHG dressing for 4 months. The dressing was changed every seven days or soiled.

Other: Chlorhexidine Gluconate-gel (CHG) Dressing

Interventions

Chlorhexidine Gluconate-gel (CHG) Dressing OTHER

Participants used Tegaderm™ CHG dressing for 4 months. The dressing was changed every seven days or soiled.

Chlorhexidine Gluconate-gel (CHG) Dressing group

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All incident PD patients

You may not qualify if:

• Patients allergic to chlorhexidine and Tegaderm dressing

Sponsors & Collaborators

• National Healthcare Group, Singapore: lead

Study Sites (1)

Allen Liu

Singapore, Singapore

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Chromogranins; Bandages

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nerve Tissue Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Equipment and Supplies

Study Officials

• Allen Yan Lun Liu

  Khoo Teck Puat Hospital, Singapore

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 5, 2023
• Study Start: September 27, 2019
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: September 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)