ESTIMATION OF THE INCIDENCE OF COLONIZATION OF PERIPHERAL VENOUS CATHETERS AFTER SKIN DISINFECTION WITH 0.5% SODIUM HYPOCHLORITE, PRECEDED OR NOT BY AN APPLICATION OF 70% ETHANOL: PILOT, MONOCENTRIC, RANDOMIZED, OPEN-LABEL STUDY

The requested reference [6f101d7e74dd756abfe31c52bfda3a93521c75f6] no longer exists in our database. It has been replaced by the current reference: [118a2be01149c07c62366755f4350b8105a3c8bc]

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2020
INTERVENTION: Trade Name: DAKIN® ‐ 0,5% Sodium Hypochlorite Product Name: DAKIN® Pharmaceutical Form: Cutaneous solution Trade Name: ALCOOL MODIFIE COOPER® ‐ 70% Ethanol Product Name: ALCOOL MODIFIE COOPER® Pharmaceutical Form: Cutaneous solution CONDITION: Bacterial colonization of peripheral venous catheters ; MedDRA version: 20.1 Level: LLT Classification code 10069718 Term: Bacterial colonization System Organ Class: 100000004862 Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: Main Objective: Estimate the incidence of colonization of peripheral venous catheters after disinfection with a 0.5% sodium hypochlorite solution preceded or not by an application of a 70% ethanol solution. Primary end point(s): Incidence of colonized catheters defined as the culture of the intravascular end of the catheter with at least 1000 colony‐forming units per mL (CFU/mL) Secondary Objective: Assess the occurrence of local or systemic catheter‐related infectious complications after disinfection with 0.5% sodium hypochlorite solution with or without application of 70% ethanol solution.; ; Assess skin tolerance after disinfection with 0.5% sodium hypochlorite solution with or without application of 70% ethanol solution.; Timepoint(s) of evaluation of this end point: The decision to remove the catheter is the responsibility of the patient's physician SECONDARY OUTCOME: Secondary end point(s): ‐ Local infection, defined as colonization of the catheter if removed for suspicion of infection, or purulent discharge at the insertion site with a positive culture or no culture at the insertion site (a negative culture, in the absence of antibiotics, eliminates the case). ; ‐ General infection, defined as colonization of the catheter in the presence of general signs of infection (fever > 38.5° or hypothermia < 36°, chills, hypotension with PAS < 90 mmHg) and total or partial regression of these signs within 48 hours after catheter removal. ; ‐ catheter‐related bacteremia/fungemia, defined as at least one positive peripheral blood culture within 48 hours of catheter removal, associated with general signs of infection (fever > 38.5° or hypothermia < 36°, chills, hypotension with PAS < 90 mmHg) and a catheter culture with the same microorganism (or pus at the site of catheter insertion), with no other infectious focus identified. ; ‐ Incidence of a positive catheter culture regardless of the threshold and the microorganism under consideration. ; ‐ Incidence of local skin reaction and its severity. ; Timepoint(s) of evaluation of this end point: Every day until the catheter is removed INCLUSION CRITERIA: ‐ Adult patient (=18 years old) requiring hospitalization in participating services ‐ Having an indication for the placement of a peripheral venous catheter for an expected duration of at least 48 hours ‐ Free subject, without guardianship or curatorship or subordination ‐ A person affiliated to or benefiting from a social security scheme. ‐ Having given free and informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Epistemonikos ID: 09f84e79623c70a57cfcd3eb53956318285a29a7
First added on: Aug 24, 2024