- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03875352
The Influence of Nursing Technique Applied at the Central Venous Catheter Insertion Site Upon the Incidence of Infection
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Moravian-Silesian Region
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Ostrava, Moravian-Silesian Region, Cechia, 70852
- University Hospital Ostrava
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Neutropenia patients
Patients with 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Local signs of inflammation
Lasso di tempo: 3 days at minimum, up to 15 days
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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
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Kateřina Hašová, Mgr., University Hospital Ostrava
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- KHO-01-CVC
- RVO-FNOs/2016 (Altro numero di sovvenzione/finanziamento: University Hospital Ostrava)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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