- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03875352
The Influence of Nursing Technique Applied at the Central Venous Catheter Insertion Site Upon the Incidence of Infection
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Moravian-Silesian Region
-
Ostrava, Moravian-Silesian Region, Tchéquie, 70852
- University Hospital Ostrava
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
|
Expérimental: No neutropenia patients
Patients with no 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Local signs of inflammation
Délai: 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.
|
3 days at minimum, up to 15 days
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Kateřina Hašová, Mgr., University Hospital Ostrava
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KHO-01-CVC
- RVO-FNOs/2016 (Autre subvention/numéro de financement: University Hospital Ostrava)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur CHG technique
-
National Taiwan University HospitalMin-Sheng General Hospital; Lotung Poh-Ai Hospital; Hualien Tzu Chi General... et autres collaborateursRecrutementInfections des voies urinairesTaïwan
-
University Hospital, GrenobleComplétéInfections liées au cathéterFrance
-
Catholic University of the Sacred Heart3M; Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, ItalyInconnue
-
3MComplétéPréparation cutanée chirurgicaleÉtats-Unis
-
Duke UniversityComplétéBactériémie associée au cathéter central (CLABSI)États-Unis
-
Icahn School of Medicine at Mount SinaiComplétéEndométrite | Infections du site opératoire | Infection; Césarienne | Chiffons de gluconate de chlorhexidine | Morbidité infectieuseÉtats-Unis
-
3MRésiliéApplication post-produit de réduction bactérienne de la flore cutanéeÉtats-Unis
-
Medline IndustriesComplété