Bacterial colonization of peripheral venous catheters MedDRA version: 20.1 Level: LLT Classification code 10069718 Term: Bacterial colonization System Organ Class: 100000004862
Conditions
Interventions
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®
Phar
Sponsors
CHU de Poitiers
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: - Hypersensitivity to any of the constituents of Dakin® and/or Cooper® modified alcohol; - History of epilepsy, - Placement of a peripheral venous catheter in the emergency room that does not allow the usual rules of hygiene to be respected; - Difficult vascular access foreseeable (drug addict, obese, non-visible veins...); - Participation in another research protocol reducing the risk of catheter-related infection; - Patient having received an antibiotic treatment in the 15 days prior to inclusion in the study; - Patient who has already participated in the study; - Subjects not affiliated with a Social Security system. - Subjects benefiting from enhanced protection, namely persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection (guardianship and trusteeship) and finally patients in emergency situations. - Pregnant or breastfeeding women, women of child-bearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy...).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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. ;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);Timepoint(s) of evaluation of this end point: The decision to remove the catheter is the responsibility of the patient's physician | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 | — |
Countries
France
Contacts
Public ContactFanny ABRIAT
CHU de Poitiers
Outcome results
None listed