Comparison of Sterile Gauze and Semi-permeable Film Dressing for Hemodialysis Central Venous Catheter

Comparison of the Efficacy of Sterile Gauze and Semi-permeable Film Dressing for Hemodialysis Non-tunneling Central Venous Catheter

This prospective single center RCT aims to compare sterile gauze and tape versus Semi-permeable film dressing on the incidence of exit-site infection, CRBSIs (catheter-related bloodstream infections), skin irritation, total bacterial count, dressing intactness and cost-benefit, nursing workload in hemodialysis patients with a non-tunneled hemodialysis catheter.

Study Overview

• Status: Recruiting
• Conditions: Infection, Bacterial
• Intervention / Treatment: Device: semi-permeable film; Device: sterile gauze and tape

Detailed Description

This prospective single center RCT aims to compare sterile gauze and tape versus Semi-permeable film dressing on the incidence of exit-site infection, CRBSIs (catheter-related bloodstream infections), skin irritation, total bacterial count, dressing intactness and cost-benefit, nursing workload in hemodialysis patients with a non-tunneled hemodialysis catheter.

154 eligible patients in our HD center will be enrolled consecutively and randomly allocated to one of the two groups according to computer-generated randomization sequences in a 1:1 ratio. Experiment group use semi-permeable film as dressing in exit-site of CVC, and a sterile gauze and tape in control group. Both groups share same disinfection and dressing change procedure. Dressings will be replaced per hemodialysis session, or as needed. Socio-demographic data and disease-related information will be collected, as well as catheterization site, physician, skin and exit status of the catheterization site at baseline. Data as listed in the beginning will be recorded in the next 2 weeks follow-up at every session, such as sign of exit-site infection, CRBSIs (catheter-related bloodstream infections), skin irritation and dryness, dressing intactness. Before the 2nd dressing change, skin around exit of CVC under dressing area will be swabbed by a cotton swab. Nursing time of dressing change will be recorded by a third nurses. Cost and benefit will be calculated and compared by the end.

• Study Type: Interventional
• Enrollment (Anticipated): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junqing Liang, Graduate; Phone Number: 8832 +8615201091164; Email: yinpin777@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Sub-Investigator: Ying Wang
      • Contact: Junqing Liang, Graduate; Phone Number: +8615201091164; Email: yinpin777@126.com
      • Sub-Investigator: Weilin Zhang
      • Sub-Investigator: Yuxiao Yang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age more than 18 years; requiring hemodialysis treatment by non-tunneled CVC inserted through subclavian vein, femoral vein, internal jugular vein by nephrologists team, allowing sufficient blood flow; competent to provide informed consent.

Exclusion Criteria:

• current systemic antibiotic therapy as a result of bacteremia in the previous 21 days; pregnancy; with a known dermatitis at the exit site or known hypersensitivity to a component of either dressing; require antibiotic lock or antibiotic ointment in exit-site for infection prevention locally

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Semi-permeable film dressing; Experiment group use semi-permeable film as dressing in exit-site of CVC and dressings will be changed per hemodialysis session, or whenever the dressing is soiled, bloody, or fell off.	Device: semi-permeable film; Experiment group use semi-permeable film as dressing in exit-site of CVC and dressings will be changed per hemodialysis session, or or whenever the dressing is soiled, bloody, or fell off.
Other: sterile gauze and tape dressing; Control group use sterile gauze and tape as dressing in exit-site of CVC and dressings will be changed per hemodialysis session, or or whenever the dressing is soiled, bloody, or fell off.	Device: sterile gauze and tape; Control group use sterile gauze and tape as dressing in exit-site of CVC and dressings will be changed per hemodialysis session, or whenever the dressing is soiled, bloody, or fell off.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
exit-site infection	redness, tenderness, swelling and/or with exudation within 2 cm around exit of CVC in the skin	before disinfectant and dressing change at every hemodialysis session within 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
catheter-related blood stream infection(CRBSI)	At least one blood culture from peripheral venous puncture was collected at CVC removal and whenever a catheter-related infection or other type of sepsis was suspected (temperature 38.2°C or 36.5°C or chills, leukocytes 10,000 or 4,000, or other signs of sepsis according the diagnosis of CDC	within 2-week follow-up or before withdrawn of hemodialysis therapy if the patient cannot reach 2 weeks
skin erythema and dryness under the dressing area	The following scale was used for erythema [modified from Fitzpatrick et al. (20)]: 0 ¼ none; 0.5 ¼ equivocal erythema; 1 ¼ slight redness, spotty and diffuse; 2 ¼ moderate uniform redness; 3 ¼ intense redness; 4 ¼ fiery red with oedema.The following scale was used for dryness:0 ¼ none; 1 ¼ slight scaling, dryness; 2 ¼ moderate scaling, dryness; 3 ¼ severe dryness with large flakes. The sum score of dryness and erythema over all assessment times served as outcome parameter.	before disinfectant and dressing change at every hemodialysis session within 2 weeks
total bacterial count	cotton swab in skin within 2 cm around the exit-site of CVC under the dressing	Once only. At the time of the 2nd dressing change after CVC insertion of each patient(dressing change usually happened at each hemodialysis therapy session)
dressing intactness	if all the corners or edges of dressing is intact, count how many corners or edges rolled up or fell off	before disinfectant and dressing change at every hemodialysis session within 2 weeks
nursing time for dressing change	how much time a dressing change procedure cost in minutes. Nursing time are recorded by other nurse using a clock while the nurse change dressing for a patient.the whole time cost of the nurse doing dressing change should be the outcome.	at any of the session, once only

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Study Director: Liangying Gan, Department of Nephrology, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: hemodialysis, Semi-permeable film
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections
• Other Study ID Numbers: RDN2020-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No