Efficacy Study Comparing 2% Chlorhexidine in 70% Isopropyl Alcohol Versus 2% Aqueous Chlorhexidine
|ClinicalTrials.gov Identifier: NCT01270776|
Recruitment Status : Unknown
Verified May 2013 by Vibhuti Shah, Mount Sinai Hospital, Canada.
Recruitment status was: Recruiting
First Posted : January 5, 2011
Last Update Posted : May 14, 2013
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].
|Condition or disease||Intervention/treatment||Phase|
|Anti-infecting Agents, Local||Drug: 2% aqueous chlorhexidine Drug: 2% Chlorhexidine 70% isopropyl alcohol||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||462 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comparison of 2% Chlorhexidine in 70% Isopropyl Alcohol Versus 2% Aqueous Chlorhexidine for Skin Antisepsis Prior to Venepuncture in Very Low Birth Weight Infants: A Planned Non-inferiority Trial|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||January 2014|
Experimental: Aqueous Chlorhexidine
The group received skin antisepsis using 2% aqueous chlorhexidine solution.
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.
Other Name: SOLU-I.V. Aqueous Swabsticks
Active Comparator: 2% Chlorhexidine 70% isopropyl alcohol
The group will receive skin antisepsis with 2% chlorhexidine solution in alcohol.
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.
Other Name: SOLU-I.V. Swabsticks
- Bacterial colony count as assessed by pre- and post cleansing skin swab culture. [ Time Frame: 24 hours ]A sterile cotton swab with be rolled 4 times across the sampling area. The swab will be broken off into tube containing 1ml of sterile normal saline. A 0.1ml aliquot of this solution will be spread onto a blood agar plate. Colony forming units (CFU) will be enumerated after aerobic incubation at 37°C for 24 hours. Swabs which yield CFU > 15 will be labeled positive for bacteria and negative if CFU < 15.
- Immediate or late Skin reactions. [ Time Frame: 24 hours ]Local adverse events will be recorded by researcher at 10 minutes after the procedure and then again at 2, 12 and 24 hours later to monitor for immediate and late local reactions. Adverse events will be recorded using a validated contact dermatitis score.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270776
|Contact: Vibhuti Shah, MD MRCP||001-416-586-4800 ext email@example.com|
|Contact: Amish Jain, MD MRCPCHfirstname.lastname@example.org|
|Mount Sinai Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 1X5|
|Contact: Vibhuti Shah, MD MRCP 001-416-586-4800 ext 4816 email@example.com|
|Contact: Amish Jain, MRCPCH (UK) 001-416-454-3013 firstname.lastname@example.org|
|Principal Investigator: Vibhuti Shah, MD MRCP|
|Study Chair:||Vibhuti Shah, MD MRCP||Mount Sinai Hospital, New York|