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

17. september 2021 oppdatert av: Liang Junqing, Peking University People's Hospital

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

154

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Junqing Liang, Graduate
  • Telefonnummer: 8832 +8615201091164
  • E-post: yinpin777@126.com

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100044
        • Rekruttering
        • Peking University People's Hospital
        • Underetterforsker:
          • Ying Wang
        • Ta kontakt med:
        • Underetterforsker:
          • Weilin Zhang
        • Underetterforsker:
          • Yuxiao Yang

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.
Annen: 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.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
exit-site infection
Tidsramme: before disinfectant and dressing change at every hemodialysis session within 2 weeks
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
catheter-related blood stream infection(CRBSI)
Tidsramme: within 2-week follow-up or before withdrawn of hemodialysis therapy if the patient cannot reach 2 weeks
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
Tidsramme: before disinfectant and dressing change at every hemodialysis session within 2 weeks
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
Tidsramme: 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)
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
Tidsramme: before disinfectant and dressing change at every hemodialysis session within 2 weeks
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
Tidsramme: at any of the session, once only
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Peking University People's Hospital

Etterforskere

  • Studieleder: Liangying Gan, Department of Nephrology, Peking University People's Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

17. mai 2021

Primær fullføring (Forventet)

31. mai 2022

Studiet fullført (Forventet)

31. desember 2022

Datoer for studieregistrering

Først innsendt

9. mars 2021

Først innsendt som oppfylte QC-kriteriene

12. mars 2021

Først lagt ut (Faktiske)

16. mars 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. september 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. september 2021

Sist bekreftet

1. september 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RDN2020-02

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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