Recruiting

Chlorhexidine vs. Isopropyl Alcohol

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT01270776

Conditions

Anti-infecting Agents, Local

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

2% aqueous chlorhexidine

2% Chlorhexidine 70% isopropyl alcohol

Study Details

Brief 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

Study ID

NCT01270776

Start date

Jan, 2011

Status verified date

May, 2013

Completion date

Jan, 2014

Anticipated

Primary completion date

Jan, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Birth weight < 1500 grams
  • Postnatal age > 48 hours and < 28 days
  • Need for venepuncture for any medical indication

Exclusion Criteria:

  • Birth weight ≥ 1500 grams
  • Infants with skin breakdown or previously documented to have skin reactions to antiseptic agent

Study Design

Enrollment

462 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Aqueous Chlorhexidine

The group received skin antisepsis using 2% aqueous chlorhexidine solution.

active comparator: 2% Chlorhexidine 70% isopropyl alcohol

The group will receive skin antisepsis with 2% chlorhexidine solution in alcohol.

Interventions

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.

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.

Primary outcome measure

  • Bacterial colony count as assessed by pre- and post cleansing skin swab culture. [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Principal Investigator:

Vibhuti Shah, MD MRCP

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

May 14, 2013

Last verified

May, 2013

Keywords

  • Randomized Controlled Trial
  • Chlorhexidine
  • Infant, Premature

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2013-05-14.