NCT04800575

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 17, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

March 9, 2021

Last Update Submit

September 17, 2021

Conditions

Infection, Bacterial

Keywords

hemodialysis, Semi-permeable film

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • catheter-related blood stream infection(CRBSI)

    within 2-week follow-up or before withdrawn of hemodialysis therapy if the patient cannot reach 2 weeks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

    before disinfectant and dressing change at every hemodialysis session within 2 weeks

  • total bacterial count

    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

    before disinfectant and dressing change at every hemodialysis session within 2 weeks

  • nursing time for dressing change

    at any of the session, once only

Study Arms (2)

Semi-permeable film dressing

EXPERIMENTAL

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

sterile gauze and tape dressing

OTHER

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

Interventions

semi-permeable filmDEVICE

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.

Semi-permeable film dressing
sterile gauze and tapeDEVICE

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.

sterile gauze and tape dressing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Liangying Gan

    Department of Nephrology, Peking University People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Junqing Liang, Graduate

CONTACT

+8615201091164yinpin777@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
nurse

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 16, 2021

Study Start

May 17, 2021

Primary Completion

May 31, 2022

Study Completion

December 31, 2022

Last Updated

September 23, 2021

Record last verified: 2021-09

Locations

CN(1)