- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03875352
The Influence of Nursing Technique Applied at the Central Venous Catheter Insertion Site Upon the Incidence of Infection
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The study was a prospective and randomized clinical trial. The study was performed at two departments of the University Hospital Ostrava.
The design and performance of the study were approved by the Ethics Committee of the University Hospital Ostrava.
The patients indicated for insertion of central venous catheter (CVC) were informed about the possible nursing techniques applied at the insertion site of the central venous catheter, participation in the study was conditioned with signing a written informed consent. The study evaluated the superiority of a new procedure in providing nursing care for patients with CVC.
Basic patient characteristics were observed and recorded according to the protocol of the study (age, sex, diagnosis), the number of days with CVC inserted, type of dressing, APACHE II score, the presence of neutropenia and the final score of assessment of local signs of inflammation, which was defined as follows:
0 points = No reddening
- point = Reddening below 2 mm in diameter around the incision
- points = Reddening below 5 mm in diameter around the incision
- points = Reddening exceeding 5 mm in diameter around the incision
- points = Purulent secretion, swelling, pain
- points = Catheter sepsis The investigators also recorded the day when the first signs of local infection were observed.
The obtained results were evaluated with standard statistical techniques (Chí-quadrate test, Fisher's exact test).
Upon inserting CVC, the type of draping was recorded (small, middle, large), and the cannulated vein (vena subclavia, left and right, vena jugularis interna, left and right, vena femoralis, left and right). A smear was obtained from around the incision site in all patients after insertion and after extraction; the smears were sent for microbiology cultivation and determination of sensitivity to antibiotic therapy. Changing of the dressings was performed in accordance with standard operating procedures of the University Hospital Ostrava. The CVC was attended under aseptic conditions, using sterile material. Surrounding of CVC was mechanically cleaned and disinfected using 2% chlorhexidine for disinfection of the skin, let to dry, and semipermeable foil was placed at the site, containing chlorhexidine gluconate. The dressing was identified with a date when it was applied. This was left in situ for 3-4 days, and the procedure was repeated.
The patients were randomized into two study groups:
- HMG Group - the patients were treated with 2% chlorhexidine for skin disinfection, HMG and transparent foil
- CHG Group - the patients were treated with 2% chlorhexidine for skin disinfection and dressing with CHG The randomization procedure further divided the patients into two study arms
1. Neutropenia Group (defined as the number of neutrophil granulocytes below 1x109/l 2. No-neutropenia Group (with a normal number of neutrophil granulocytes
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
Moravian-Silesian Region
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Ostrava, Moravian-Silesian Region, Tschechien, 70852
- University Hospital Ostrava
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Age over 18 years
- Patients with CVC
- Hospitalization at ICU
Exclusion Criteria:
- Allergy to HMG
- Allergy to transparent foil
- CVC insertion shorter than 3 days
- Strong bleeding from CVC insertion site
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Neutropenia patients
Patients with neutropenia were treated using the CHG and HMG technique.
|
The CHG technique includes treatment using dressing with chlorhexidine.
The HMG technique includes treatment using hydrophilic methacrylate gel and transparent foil.
|
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Experimental: No neutropenia patients
Patients with no neutropenia were treated using the CHG and HMG technique.
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The CHG technique includes treatment using dressing with chlorhexidine.
The HMG technique includes treatment using hydrophilic methacrylate gel and transparent foil.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Local signs of inflammation
Zeitfenster: 3 days at minimum, up to 15 days
|
The local signs of inflammation were observed in both study arms and both interventions, and were assessed according to the scoring system described in detail description.
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3 days at minimum, up to 15 days
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Kateřina Hašová, Mgr., University Hospital Ostrava
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Chambers ST, Sanders J, Patton WN, Ganly P, Birch M, Crump JA, Spearing RL. Reduction of exit-site infections of tunnelled intravascular catheters among neutropenic patients by sustained-release chlorhexidine dressings: results from a prospective randomized controlled trial. J Hosp Infect. 2005 Sep;61(1):53-61. doi: 10.1016/j.jhin.2005.01.023.
- Crawford AG, Fuhr JP Jr, Rao B. Cost-benefit analysis of chlorhexidine gluconate dressing in the prevention of catheter-related bloodstream infections. Infect Control Hosp Epidemiol. 2004 Aug;25(8):668-74. doi: 10.1086/502459.
- Ho KM, Litton E. Use of chlorhexidine-impregnated dressing to prevent vascular and epidural catheter colonization and infection: a meta-analysis. J Antimicrob Chemother. 2006 Aug;58(2):281-7. doi: 10.1093/jac/dkl234. Epub 2006 Jun 6. Erratum In: J Antimicrob Chemother. 2010 Apr;65(4):815.
- Lorente L, Henry C, Martin MM, Jimenez A, Mora ML. Central venous catheter-related infection in a prospective and observational study of 2,595 catheters. Crit Care. 2005;9(6):R631-5. doi: 10.1186/cc3824. Epub 2005 Sep 28.
- Mermel LA. What is the predominant source of intravascular catheter infections? Clin Infect Dis. 2011 Jan 15;52(2):211-2. doi: 10.1093/cid/ciq108.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KHO-01-CVC
- RVO-FNOs/2016 (Andere Zuschuss-/Finanzierungsnummer: University Hospital Ostrava)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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