Clinical
Protocol
1. Preparation
and
Surgical
Use
a. Wound
Bed
Prep
i. Ensure
wound
is
clear
of
any
clinical
sign
of
infection.
ii. Debride
wound
to
a
viable
wound
base.
b. Removal
of
AmnioExcel
i. Open
the
peelable
corner
of
the
outer
pouch
(not
sterile)
and
present
the
inner
pouch
(contains
AmnioExCel
and
is
sterile)
onto
the
sterile
field.
ii. Slowly
peel
the
corner
of
the
inner
peel
pouch
and
grasp
AmnioExCel
along
with
mesh
with
fingers
or
sterile
forceps.
NOTE:
Take
special
care
when
removing
AmnioExCel
from
the
internal
pouch
as
the
tissue
is
extremely
thin
and
lightweight.
USE
GOOD
FORCEPS!
2. AmnioExCel
Preparation
a. Use
sterile
dry
scissors
to
cut
AmnioExCel
and
mesh
to
fit
so
that
it
overlaps
the
wound
margins
by
approximately
1
2
mm.
b. AmnioExCel
can
be
fenestrated
in
cases
of
copious
exudate.
3. AmnioExCel
Orientation
a. AmnioExCel
should
be
placed
with
tissue
in
contact
with
the
wound
(mesh
anterior
to
the
tissue)
for
proper
orientation.
b. AmnioExCel
can
be
hydrated
while
adhering
to
the
wound
site
with
sterile
saline
solution.
Take
care
not
to
displace
AmnioExCel
from
the
wound
while
hydrating.
c. AmnioExCel
can
be
fixated
to
wound
site
via
suture
and/or
tissue
adhesives.
4. Primary
Dressing
a. AmnioExCel
should
be
covered
with
a
non-adherent
topical
layer.
b. AmnioExCel
and
topical
dressing
should
not
be
disturbed
for
at
least
2
weeks
if
possible.
c. Infections
that
occur
should
be
treated
according
to
facility
protocol.
5. Secondary
Dressing
a. AmnioExCel
healing
is
expedited
in
a
moist
wound
environment.
Use
appropriate
moisture
management
dressings
for
the
wound
type
and
treatment
ideology.
6. Support
Therapies
a. AmnioExCel
is
compatible
with
compression,
negative
pressure
and
offloading
therapies.
b. AmnioExCel
is
also
compatible
with
hyperbaric
oxygen
therapy.
7. Re-application
of
AmnioExCel
a. If
clinical
signs
of
slowing
wound
margin
reduction
exist,
re-apply
AmnioExCel
per
same
protocol.
Copyright
2012
BioPathways/LUXmed.
Confidential
Company
Material.
All
Rights
Reserved.