Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

17 september 2021 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

154

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studieorter

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100044
        • Rekrytering
        • Peking University People's Hospital
        • Underutredare:
          • Ying Wang
        • Kontakt:
        • Underutredare:
          • Weilin Zhang
        • Underutredare:
          • Yuxiao Yang

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
exit-site infection
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
catheter-related blood stream infection(CRBSI)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Peking University People's Hospital

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

17 maj 2021

Primärt slutförande (Förväntat)

31 maj 2022

Avslutad studie (Förväntat)

31 december 2022

Studieregistreringsdatum

Först inskickad

9 mars 2021

Först inskickad som uppfyllde QC-kriterierna

12 mars 2021

Första postat (Faktisk)

16 mars 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 september 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 september 2021

Senast verifierad

1 september 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • RDN2020-02

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Infektion, bakteriell

Kliniska prövningar på semi-permeable film

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Israel

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera