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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

NCT04391660 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2021-01-22

No results posted yet for this study

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.

Conditions

  • Skin Disinfection Before Peripheral Venous Catheter Insertion

Interventions

DRUG

0.5% 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.

DRUG

0.5% 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 & Collaborators

  • Poitiers University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2021-01-08
Completion
2021-01-08

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04391660 on ClinicalTrials.gov