Efficacy Study Comparing 2% Chlorhexidine in 70% Isopropyl Alcohol Versus 2% Aqueous Chlorhexidine
NCT ID: NCT01270776
Last Updated: 2013-05-14
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
462 participants
Study Classification
INTERVENTIONAL
Study Start Date
2011-01-31
Study Completion Date
2014-01-31
Brief Summary
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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 \[limited amount for short duration\].
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 \[limited amount for short duration\].
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Detailed Description
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Venepuncture, either to obtain blood samples for laboratory investigations or to place peripheral intravascular catheters, is an integral part of care in neonatal intensive care units (NICUs). In sick neonates, apart for collection of blood samples venous cannulation is necessary for provision of total parenteral nutrition and administration of medications; however, these skin-breaking procedures places them at risk for local and systemic infectious complications. Bacterial organisms inhabited on the skin travel through the insertion site into the catheter tract and colonize the catheter tip. This is postulated to be a common route of infection for peripherally inserted catheters, hence the need for maintaining optimal skin antisepsis during such procedures.
It is not possible to completely sterilize the skin; however skin antisepsis aims to reduce the number of viable resident organisms on or in the skin and to destroy pathogenic organisms that may be on the skin. Several antiseptic agents are available for skin preparation including 70% alcohol, chlorhexidine (with 70% alcohol or aqueous) and povidone-iodine (PI). Most of the studies comparing the efficacy to these agents have been conducted in adults while there is paucity of studies regarding their use in VLBW infants.
Chlorhexidine, one of the most commonly used biocide antiseptic product, is a broad spectrum bactericidal agent. It diffuses through the outer cell wall and then attacks the bacterial cytoplasmic or inner membrane leading to cell death. Chlorhexidine is active against common gram negative and gram positive pathogens as well as yeast. Numerous randomized controlled trials have been performed in adult patients supporting the superiority of chlorhexidine as skin disinfectant. One of the more influential studies was conducted by Hibbard et al in 2002. The investigators compared 70% isopropyl alcohol; 2% CHG in 70% alcohol; and 2% aqueous CHG in healthy volunteers by obtaining abdominal and inguinal skin swabs at various time points after application. They concluded that all three solutions had excellent and comparable immediate antimicrobial action at 10 minutes \& 6 hours after application but 2% CHG in 70% alcohol had better persistent action with antisepsis effectiveness at 24 hours. To date, this is the only study that has compared 2% CHG with and without alcohol directly.
Even though all the above mentioned solutions have proven excellent safety profile in adults, there are significant concerns with their use in preterm neonates. The skin of the newborn infant, especially the preterm infant, is more susceptible to damage from antiseptic agents. Iodine preparations have been associated with transient suppression of thyroid function related to systemic absorption. Alcohol and iodine have been reported to be associated with severe skin injury including blistering, burns and sloughing. Systemic absorption of chlorhexidine is rare, although it has been reported to occur when alcohol is used concurrently. These adverse events have only been reported when these solutions were used for placements of umbilical lines presumably because larger surface area of skin is exposed to a greater quantity of solution for longer duration. Also during such procedures the solution can often get pooled over abdominal skin if used in excessive quantity. No serious adverse event has ever been reported during venepuncture (from either form of chlorhexidine). Such significant concerns with the use of iodine and alcohol containing solutions and more widespread availability of aqueous chlorhexidine has led many NICU's to endorse its use without systematically evaluating its efficacy in this population or standardization of method of application. Therefore, it is important to conduct a well designed study to systematically evaluate the effectiveness of using a limited amount of 2% aqueous CHG in clinical practice.
This double blind planned non-inferiority randomized controlled trial will compare the efficacy and safety of 2% chlorhexidine in 70% isopropyl alcohol (current standard of practice in the NICU) to 2% aqueous chlorhexidine (investigational agent) for skin antisepsis prior to venepuncture in very low birth weight (VLBW, birth weight \< 1,500 grams) infants. The effectiveness (success) of skin antisepsis will be assessed by collecting pre- and post- cleansing skin swabs. The skin swabs will then be cultured in the microbiology laboratory and pre- and post- microbial growth will be compared between the two groups.
Changes to the study protocol:
1. Results of the interim analysis:
Following the pre-planned interim analysis, it is shown that the initial assumption of standard solution clearance rate used for sample size calculation (92%) was higher than the rate actually observed in the dataset collected up to the interim analysis stage by the investigators (84%). With the assumption of 84% clearance rate for standard solution, the study would have required a bigger sample size of 231 subjects in each arm. With the interim data, the two groups show exactly the same rates of clearance (84%) but with wide confidence intervals for the clearance rate estimates due to smaller sample size. Based on this interim analysis we do not statistically show non-inferiority of the test solution to standard solution. However to obtain a definitive answer we now need to modify our sample size to 462 subjects (231 subjects per arm).
2. This will now be a multi-center study. We have added SickKids, Toronto as an additional site for recruitment. We have obtained REB approval from SickKids.
It is not possible to completely sterilize the skin; however skin antisepsis aims to reduce the number of viable resident organisms on or in the skin and to destroy pathogenic organisms that may be on the skin. Several antiseptic agents are available for skin preparation including 70% alcohol, chlorhexidine (with 70% alcohol or aqueous) and povidone-iodine (PI). Most of the studies comparing the efficacy to these agents have been conducted in adults while there is paucity of studies regarding their use in VLBW infants.
Chlorhexidine, one of the most commonly used biocide antiseptic product, is a broad spectrum bactericidal agent. It diffuses through the outer cell wall and then attacks the bacterial cytoplasmic or inner membrane leading to cell death. Chlorhexidine is active against common gram negative and gram positive pathogens as well as yeast. Numerous randomized controlled trials have been performed in adult patients supporting the superiority of chlorhexidine as skin disinfectant. One of the more influential studies was conducted by Hibbard et al in 2002. The investigators compared 70% isopropyl alcohol; 2% CHG in 70% alcohol; and 2% aqueous CHG in healthy volunteers by obtaining abdominal and inguinal skin swabs at various time points after application. They concluded that all three solutions had excellent and comparable immediate antimicrobial action at 10 minutes \& 6 hours after application but 2% CHG in 70% alcohol had better persistent action with antisepsis effectiveness at 24 hours. To date, this is the only study that has compared 2% CHG with and without alcohol directly.
Even though all the above mentioned solutions have proven excellent safety profile in adults, there are significant concerns with their use in preterm neonates. The skin of the newborn infant, especially the preterm infant, is more susceptible to damage from antiseptic agents. Iodine preparations have been associated with transient suppression of thyroid function related to systemic absorption. Alcohol and iodine have been reported to be associated with severe skin injury including blistering, burns and sloughing. Systemic absorption of chlorhexidine is rare, although it has been reported to occur when alcohol is used concurrently. These adverse events have only been reported when these solutions were used for placements of umbilical lines presumably because larger surface area of skin is exposed to a greater quantity of solution for longer duration. Also during such procedures the solution can often get pooled over abdominal skin if used in excessive quantity. No serious adverse event has ever been reported during venepuncture (from either form of chlorhexidine). Such significant concerns with the use of iodine and alcohol containing solutions and more widespread availability of aqueous chlorhexidine has led many NICU's to endorse its use without systematically evaluating its efficacy in this population or standardization of method of application. Therefore, it is important to conduct a well designed study to systematically evaluate the effectiveness of using a limited amount of 2% aqueous CHG in clinical practice.
This double blind planned non-inferiority randomized controlled trial will compare the efficacy and safety of 2% chlorhexidine in 70% isopropyl alcohol (current standard of practice in the NICU) to 2% aqueous chlorhexidine (investigational agent) for skin antisepsis prior to venepuncture in very low birth weight (VLBW, birth weight \< 1,500 grams) infants. The effectiveness (success) of skin antisepsis will be assessed by collecting pre- and post- cleansing skin swabs. The skin swabs will then be cultured in the microbiology laboratory and pre- and post- microbial growth will be compared between the two groups.
Changes to the study protocol:
1. Results of the interim analysis:
Following the pre-planned interim analysis, it is shown that the initial assumption of standard solution clearance rate used for sample size calculation (92%) was higher than the rate actually observed in the dataset collected up to the interim analysis stage by the investigators (84%). With the assumption of 84% clearance rate for standard solution, the study would have required a bigger sample size of 231 subjects in each arm. With the interim data, the two groups show exactly the same rates of clearance (84%) but with wide confidence intervals for the clearance rate estimates due to smaller sample size. Based on this interim analysis we do not statistically show non-inferiority of the test solution to standard solution. However to obtain a definitive answer we now need to modify our sample size to 462 subjects (231 subjects per arm).
2. This will now be a multi-center study. We have added SickKids, Toronto as an additional site for recruitment. We have obtained REB approval from SickKids.
Conditions
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Anti-infecting Agents, Local
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Aqueous Chlorhexidine
The group received skin antisepsis using 2% aqueous chlorhexidine solution.
Group Type
EXPERIMENTAL
2% aqueous chlorhexidine
Intervention Type
DRUG
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
The group will receive skin antisepsis with 2% chlorhexidine solution in alcohol.
Group Type
ACTIVE_COMPARATOR
2% Chlorhexidine 70% isopropyl alcohol
Intervention Type
DRUG
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.
Interventions
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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.
Intervention Type
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.
Intervention Type
DRUG
Other Intervention Names
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SOLU-I.V. Aqueous Swabsticks
SOLU-I.V. Swabsticks
Eligibility Criteria
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Inclusion Criteria
* Birth weight \< 1500 grams
* Postnatal age \> 48 hours and \< 28 days
* Need for venepuncture for any medical indication
* 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
* Infants with skin breakdown or previously documented to have skin reactions to antiseptic agent
Minimum Eligible Age
48 Hours
Maximum Eligible Age
28 Days
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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The Physicians' Services Incorporated Foundation
OTHER
Sponsor Role
collaborator
Mount Sinai Hospital, Canada
OTHER
Sponsor Role
lead
Responsible Party
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Vibhuti Shah
Staff Neonatologist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Vibhuti Shah, MD MRCP
Role: STUDY_CHAIR
MOUNT SINAI HOSPITAL
Locations
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Mount Sinai Hospital
Toronto, Ontario, Canada
Site Status
RECRUITING
Countries
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Canada
Central Contacts
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Facility Contacts
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References
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Keyworth N, Millar MR, Holland KT. Development of cutaneous microflora in premature neonates. Arch Dis Child. 1992 Jul;67(7 Spec No):797-801. doi: 10.1136/adc.67.7_spec_no.797.
Reference Type
BACKGROUND
D'Angio CT, McGowan KL, Baumgart S, St Geme J, Harris MC. Surface colonization with coagulase-negative staphylococci in premature neonates. J Pediatr. 1989 Jun;114(6):1029-34. doi: 10.1016/s0022-3476(89)80457-3.
Reference Type
BACKGROUND
McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999 Jan;12(1):147-79. doi: 10.1128/CMR.12.1.147.
Reference Type
BACKGROUND
Maki DG, Ringer M, Alvarado CJ. Prospective randomised trial of povidone-iodine, alcohol, and chlorhexidine for prevention of infection associated with central venous and arterial catheters. Lancet. 1991 Aug 10;338(8763):339-43. doi: 10.1016/0140-6736(91)90479-9.
Reference Type
BACKGROUND
Chaiyakunapruk N, Veenstra DL, Lipsky BA, Saint S. Chlorhexidine compared with povidone-iodine solution for vascular catheter-site care: a meta-analysis. Ann Intern Med. 2002 Jun 4;136(11):792-801. doi: 10.7326/0003-4819-136-11-200206040-00007.
Reference Type
BACKGROUND
Valles J, Fernandez I, Alcaraz D, Chacon E, Cazorla A, Canals M, Mariscal D, Fontanals D, Moron A. Prospective randomized trial of 3 antiseptic solutions for prevention of catheter colonization in an intensive care unit for adult patients. Infect Control Hosp Epidemiol. 2008 Sep;29(9):847-53. doi: 10.1086/590259.
Reference Type
BACKGROUND
Hibbard JS, Mulberry GK, Brady AR. A clinical study comparing the skin antisepsis and safety of ChloraPrep, 70% isopropyl alcohol, and 2% aqueous chlorhexidine. J Infus Nurs. 2002 Jul-Aug;25(4):244-9. doi: 10.1097/00129804-200207000-00007.
Reference Type
BACKGROUND
Malathi I, Millar MR, Leeming JP, Hedges A, Marlow N. Skin disinfection in preterm infants. Arch Dis Child. 1993 Sep;69(3 Spec No):312-6. doi: 10.1136/adc.69.3_spec_no.312.
Reference Type
BACKGROUND
Garland JS, Buck RK, Maloney P, Durkin DM, Toth-Lloyd S, Duffy M, Szocik P, McAuliffe TL, Goldmann D. Comparison of 10% povidone-iodine and 0.5% chlorhexidine gluconate for the prevention of peripheral intravenous catheter colonization in neonates: a prospective trial. Pediatr Infect Dis J. 1995 Jun;14(6):510-6. doi: 10.1097/00006454-199506000-00008.
Reference Type
BACKGROUND
Baumgartner C, Constant H, Putet G, Aulagner G. Cutaneous antiseptic efficacy of two ethanol chlorhexidine dilutions for neonatal venepuncture. Journal De Pharmacie Clinique 1998;17:109-12.
Reference Type
BACKGROUND
Linder N, Prince S, Barzilai A, Keller N, Klinger G, Shalit I, Prince T, Sirota L. Disinfection with 10% povidone-iodine versus 0.5% chlorhexidine gluconate in 70% isopropanol in the neonatal intensive care unit. Acta Paediatr. 2004 Feb;93(2):205-10. doi: 10.1080/08035250310008159.
Reference Type
BACKGROUND
Lilley C, Powls A, Gray A. A prospective randomised double blind Comparison of 0.5% versus 0.05% aqueous Chlorhexidine for skin antisepsis prior to line insertion in neonates. Arch. Dis. Child. 2006;91;17-19.
Reference Type
BACKGROUND
Garland JS, Alex CP, Uhing MR, Peterside IE, Rentz A, Harris MC. Pilot trial to compare tolerance of chlorhexidine gluconate to povidone-iodine antisepsis for central venous catheter placement in neonates. J Perinatol. 2009 Dec;29(12):808-13. doi: 10.1038/jp.2009.161. Epub 2009 Oct 8.
Reference Type
BACKGROUND
Mannan K, Chow P, Lissauer T, Godambe S. Mistaken identity of skin cleansing solution leading to extensive chemical burns in an extremely preterm infant. Acta Paediatr. 2007 Oct;96(10):1536-7. doi: 10.1111/j.1651-2227.2007.00376.x. Epub 2007 Aug 28.
Reference Type
BACKGROUND
Reynolds PR, Banerjee S, Meek JH. Alcohol burns in extremely low birthweight infants: still occurring. Arch Dis Child Fetal Neonatal Ed. 2005 Jan;90(1):F10. doi: 10.1136/adc.2004.054338. No abstract available.
Reference Type
BACKGROUND
Upadhyayula S, Kambalapalli M, Harrison CJ. Safety of anti-infective agents for skin preparation in premature infants. Arch Dis Child. 2007 Jul;92(7):646-7. doi: 10.1136/adc.2007.117002. No abstract available.
Reference Type
BACKGROUND
Datta MK, Clarke P. Current practices in skin antisepsis for central venous catheterisation in UK tertiary-level neonatal units. Arch Dis Child Fetal Neonatal Ed. 2008 Jul;93(4):F328. doi: 10.1136/adc.2008.137430. No abstract available.
Reference Type
BACKGROUND
Keyworth N, Millar MR, Holland KT. Swab-wash method for quantitation of cutaneous microflora. J Clin Microbiol. 1990 May;28(5):941-3. doi: 10.1128/jcm.28.5.941-943.1990.
Reference Type
BACKGROUND
Maki DG, Ringer M. Evaluation of dressing regimens for prevention of infection with peripheral intravenous catheters. Gauze, a transparent polyurethane dressing, and an iodophor-transparent dressing. JAMA. 1987 Nov 6;258(17):2396-403.
Reference Type
BACKGROUND
Jain A, Deshpande P, Yoon EW, Lee KS, McGeer A, Shah V. 2% aqueous vs alcohol-based chlorhexidine for skin antisepsis in VLBW neonates undergoing peripheral venipuncture: a non-inferiority trial. J Perinatol. 2022 May;42(5):636-641. doi: 10.1038/s41372-022-01337-1. Epub 2022 Feb 19.
Reference Type
DERIVED
Other Identifiers
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10 - 0112 - E
Identifier Type: -
Identifier Source: org_study_id
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