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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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04391660
Acronym
DACLEAN
Enrollment
240
Registered
2020-05-18
Start date
2020-06-15
Completion date
2021-01-08
Last updated
2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Disinfection Before Peripheral Venous Catheter Insertion

Brief summary

The peripheral venous catheter is the most commonly used medical device in the hospital setting. Infectious complications are infrequent, bacterial or fungal, and local or systemic (catheter-related bacteremia). The latter prolong the length of hospitalization and increase the cost of care and mortality. For peripheral venous catheters, the risk of catheter-related bacteremia is lower (0.2-0.7 episodes per 1000 catheter days) than for other intravascular devices. However, the much higher number of peripheral venous catheters used explains a total number of infections close to that of other catheters. Colonization is usually the preliminary step to catheter infection. It is far more common than infection. Skin disinfection prior to catheter insertion is therefore essential to prevent this complication. Currently, Chlorhexidine or Povidone Iodine in alcoholic solution is recommended before insertion of a peripheral venous catheter. Although rare, allergies may contraindicate these antiseptics. The widespread use of antiseptics in recent years for hand disinfection, mouthwashes or body baths could increase the risk of the development of strains that have become less sensitive, or even resistant, to currently available antiseptics. Allergies and reduced sensitivity require the search for alternatives to currently available solutions. Sodium hypochlorite is used to disinfect mucous membranes or healthy skin before an invasive procedure in children under 30 months of age. Very few studies have evaluated its efficacy in adults for this same indication, despite the fact that it was the first antiseptic used to prevent infections. The aim of this study is to estimate the colonization rate of peripheral venous catheters after skin disinfection with 0.5% sodium hypochlorite (Dakin®) alone or preceded by an application of 70% ethanol.

Interventions

DRUG0.5% sodium hypochlorite solution

Disinfection with a 0.5% sodium hypochlorite solution applied with a sterile compress. This same antiseptic will be used at each dressing change.

DRUG0.5% sodium hypochlorite solution and 70% ethanol

Disinfection with a 0.5% sodium hypochlorite solution applied with a sterile compress preceded by an application of 70% ethanol with a sterile compress, for its immediate bactericidal action. 0.5% sodium hypochlorite solution will be applied once the alcohol has evaporated and the skin is visually dried. These same antiseptics will be used at each dressing change.

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

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

MeasureTime frame
Incidence of colonized cathetersUp to 14 days

Secondary

MeasureTime frameDescription
Local infection, defined as colonization of the catheter 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)Up to 14 days
General infection, defined as colonization of the catheter in the presence of general signs of infection and total or partial regression of these signs within 48 hours after catheter removalUp to 16 daysGeneral 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/fungemiaUp to 14 days
Incidence of a positive catheter culture regardless of the threshold and the microorganism under considerationUp to 14 days
Incidence of local skin reaction and its severityUp to 14 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026