Completed

NCT Number: NCT04391660

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

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.

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Key information

Conditions

Skin Disinfection Before Peripheral Venous Catheter Insertion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of Poitiers

Poitiers, 86021, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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...).

Treatment and study plan

0.5% sodium hypochlorite solution

Drug

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

0.5% sodium hypochlorite solution and 70% ethanol

Drug

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.

Primary outcomes

Incidence of colonized catheters

Time frame: Up to 14 days

Secondary outcomes

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)

Time frame: 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 removal

Time frame: Up to 16 days

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

Time frame: Up to 14 days
Incidence of a positive catheter culture regardless of the threshold and the microorganism under consideration

Time frame: Up to 14 days
Incidence of local skin reaction and its severity

Time frame: Up to 14 days

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Acronym: DACLEAN

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: May 18, 2020
Registry last updated: Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.