QUALE ANTISETTICO PER LA CUTE DEL NEONATO?
GIANCARLO SCOPPETTUOLO
CHG Skin Preparation (applied before catheter insertion and with every dressing change) Swabable Needleless Connector Intraluminal colonization Extraluminal colonization Modified, Courtesy of R. Garcia, MD
Quale clorexidina?
Clorexidina gluconato al 2% in soluzione alcolica
Preferib. in alcool
isopropilico al 70% Preferib. colorata
Preferib. in applicatori monodose
Preferib. in
Transepidermal
Water
Loss
(TEWL)
“ShapingtheFutureofPediatricVascularAccess2012”
• Water of respiration normally moves through the stratum corneum from below.
• The rate of transepidermal water loss (TEWL, g/m2/hr) is a measure
of skin barrier integrity
Full
Term
Infant
Skin
“ShapingtheFutureofPediatricVascularAccess2012”
Healthy infants
•
Well-formed
stratum
corneum…..note
multiple
layers
•
Thick
epidermis
•
Structural
proteins
Premature
Infant
Skin
“ShapingtheFutureofPediatricVascularAccess2012”
•
Stratum
corneum
poorly
developed
or
absent
•
Thin
epidermis
•
Dermis
not
fully
“Dressing”
the
NICU
Patient
Chlorhexidine
Gluconate,
Skin
Antiseptics
and
Neonatal
Skin
Integrity
CHG
Safety
in
Premature
Infants
• Issues: systemic absorption, skin toxicity• Concern: hexachlorophene caused neurotoxicity • Hexachlorophene:
– Bacteriostatic
– disruptsbacterial cell wall – slow onset efficacy
• CHG: – – – – Bacteriocidal
increases cellmembrane permeability rapid onset
binds to SC proteins
ChapmanA,etal. JPerinatol(2012);32(1):4-9
CHG
Premature
Skin
Permeation
•
•
•
•
Three
studies:
preterms
≥
27
and
<
32
wks
GA
Age
at
evaluation:
0
–
28
days
CHG
blood
levels:
0
–
214
ng/ml
No
infants
23
–
26
wks
GA
AggettPetal. ArchDisChild(1981);56(11):878-880 CowenJ,etal. ArchDischild(1979);54(5):379-383 GarlandJ,etal. JPerinatol(2009);29:808-813
Skin
Effects
in
Premature
Infants
•
There
are
reports
of
burns
in
infants
of
24
-
26
weeks
GA
from
alcohol-based
preparations,
including
CHG
in
70%
isopropanol.
“ShapingtheFutureofPediatricVascularAccess2012”
ReynoldsPetal,ArchDisChildFetalNeonatalEd2005;90:F10. WatkinsAetal,JPaediatrChildHealth1992;28:306-8.
Skin
Effects
in
Premature
Infants
• Parallel groups of 715 NICU patients with central venouscatheters.
• Skin treated with isopropanol and covered with
– polyurethane dressing
– chlorhexidine patch (early version)
• Severe contact dermatitis in 5.7% of CHG patch group 22.5 - 26.5 wks GA
• Patch effects not determined
“ShapingtheFutureofPediatricVascularAccess2012”
CHG
versus
PI
in
Neonates
• Pilot parallel comparison: 2% CHG (alcohol) vs. 10% Povidone Iodine
• 48 neonates ≥ 1500 g (~ 30wks GA) and ≥ 7 days • No catheter related BSIs in either group
• No dermatitis - CHG or PI (i.e., ≥ 2,no pink-red all area) • CHG absorption occurred:
– 7 of10 had blood CHG between 13 – 100 ng/ml
• Studies needed in younger preterms
“ShapingtheFutureofPediatricVascularAccess2012”
Investigator
Comments
•
“The
FDA
limited
study
enrollment
to
neonates
who
were
at
least
7
days
old
and
weighed
more
than
1500
g
because
of
concerns
for
the
development
of
contact
dermatitis
in
low-birth-weight
neonates
exposed
to
topical
CHG.”
•
This
restriction
was
applied
because
a
previous
study
(same
author)
had
6%
of
subjects
with
contact
dermatitis
from
a
CHG-impregnated
dressing.
“ShapingtheFutureofPediatricVascularAccess2012”
CHG
Use
in
NICUs
•
A
survey
of
90
NICU
training
units
found:
55 39 14 28 59
Used CHG, central venous catheter care No restrictions
Restrictions: GA, actual age or birth weight Reported adverse reactions, all skin related
17 burns, 2 erosions, 9 erythema
Had concerns: Off label use, Immature skin, Limited safety data
TammaP,etal. InfectControlHosp Epidemiol(2010);31(3):846-849
Effect
of
CHG
on
Skin
Integrity
“ShapingtheFutureofPediatricVascularAccess2012”
Hypothesis
•
Treatment
with
CHG
will
not
alter
the
normal
skin
barrier
development
in
the
high
risk
neonate.
–
Skin
treated
with
CHG
and
a
semipermeable
dressing
(Tegaderm
™)
will
not
differ
from
skin
Disinfect,
Dress
&
Secure
SharpeE. AdvancesinNeonatalCare(2008);8(3):150-162
“ShapingtheFutureofPediatricVascularAccess2012”
1. Disinfect with Chloroprep®
2. Apply transparent
Methods
“ShapingtheFutureofPediatricVascularAccess2012”
• Within subject design • Compare three regions
– PICC site with CHG and semipermeable dressing (Tegaderm™)
– Contralateral site with dressing only (2.5 cm2)
– Adjacent site untreated control
• Immediate response to CHG application • Skin effects over time
Dressing
Removal
Clinical
Response
“ShapingtheFutureofPediatricVascularAccess2012”
PICC site – dressing
Presidi a rilascio continuo di clorexidina
BIOPATCH
CONCLUSIONI
u Nell’adulto e nel neonato a termine la clorexidina al 2% in soluzione è
da considerarsi l’antisettico di scelta, senza particolari preoccupazioni per la possibile insorgenza di effetti collaterali
u Nel neonato al di sotto delle 26-26 settimane e dei 1000 g di peso, sono
segnalate reazioni di gravità variabili, anche molto rilevati
u La reale entità di tali reazioni non è nota
u Non esiste un vero e proprio divieto all’utilizzo della clorexidina in questa
popolazione di neonati, ma solo un rilevante invito all’utilizzo con cautela
u Per minimizzare le reazioni senza rinunciare ai notevoli vantaggi della
