Efficacy Study Comparing 2% Chlorhexidine in 70% Isopropyl Alcohol Versus 2% Aqueous Chlorhexidine
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Purpose
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 | Intervention |
|---|---|
|
Anti-infecting Agents, Local |
Drug: 2% aqueous chlorhexidine Drug: 2% Chlorhexidine 70% isopropyl alcohol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- Bacterial colony count as assessed by pre- and post cleansing skin swab culture. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 462 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 28 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Vibhuti Shah, MD MRCP | 001-416-586-4800 ext 4816 | vshah@mtsinai.on.ca |
| Contact: Amish Jain, MD MRCPCH | 001-416-454-3013 | amish.jain@utoronto.ca |
| Canada, Ontario | |
| Mount Sinai Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Contact: Vibhuti Shah, MD MRCP 001-416-586-4800 ext 4816 vshah@mtsinai.on.ca | |
| Contact: Amish Jain, MRCPCH (UK) 001-416-454-3013 amish.jain@utoronto.ca | |
| Principal Investigator: Vibhuti Shah, MD MRCP | |
| Study Chair: | Vibhuti Shah, MD MRCP | Mount Sinai Hospital, New York |
More Information
Publications:
| Responsible Party: | Vibhuti Shah, Staff Neonatologist, Mount Sinai Hospital, Canada |
| ClinicalTrials.gov Identifier: | NCT01270776 History of Changes |
| Other Study ID Numbers: | 10 - 0112 - E |
| Study First Received: | January 4, 2011 |
| Last Updated: | May 13, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Mount Sinai Hospital, Canada:
|
Randomized Controlled Trial Chlorhexidine Infant, Premature |
Additional relevant MeSH terms:
|
Ethanol Chlorhexidine Chlorhexidine gluconate Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents Disinfectants Dermatologic Agents |
ClinicalTrials.gov processed this record on May 16, 2013