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Efficacy Study Comparing 2% Chlorhexidine in 70% Isopropyl Alcohol Versus 2% Aqueous Chlorhexidine

NCT01270776 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 462

Last updated 2013-05-14

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy of two different antiseptic solutions (2%chlorhexidine in 70% alcohol with 2% aqueous chlorhexidine)when used in a standardized controlled manner in cleansing the skin of infants with birth weight less than 1500 grams prior to a skin breaking procedure (venepuncture).

The investigators hypothesize that the use of limited amount of 2% aqueous chlorhexidine solution will be as effective as the same amount of 2% chlorhexidine in 70% alcohol for skin antisepsis and that limited exposure to 2% aqueous CHG may be associated with less adverse skin reactions.

Literature from adults has shown that both 2% chlorhexidine in 70% alcohol as well as 2% aqueous chlorhexidine can provide effective skin antisepsis though alcohol containing solution had more long lasting effect. It is also well known from many case reports that alcohol containing products when used to clean abdominal skin for neonatal procedures can cause severe skin damage in preterm infants. This has lead many neonatal units to adopt aqueous chlorhexidine as the antiseptic agent of choice without robust evidence to support its use or standardization of method of application.Both these solutions are widely used in neonatal intensive care units across the globe including Canada.

By conducting this trial, the investigators want to evaluate the efficacy and safety of 2% aqueous chlorhexidine as an antiseptic agent when used in a controlled manner \[limited amount for short duration\].

Conditions

  • Anti-infecting Agents, Local

Interventions

DRUG

2% aqueous chlorhexidine

A single application of a swabstick impregnated with the antiseptic solution over the desired area. The imparted solution will be allowed to air dry with a minimum time of 30 seconds before intervention.

DRUG

2% Chlorhexidine 70% isopropyl alcohol

single application of a swabstick impregnated with the antiseptic solution over the desired area. The imparted solution will be allowed to air dry with a minimum time of 30 seconds before intervention.

Sponsors & Collaborators

  • The Physicians' Services Incorporated Foundation

    collaborator OTHER

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Vibhuti Shah, MD MRCP · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
48 Hours
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Canada

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 NCT01270776 on ClinicalTrials.gov