Ethicon DERMABOND PRINEO User manual

Patient Selection
DO NOT use on patients with known hypersensitivity to cyanoacrylate, formaldehyde, benzalkonium chloride, or pressure-
sensitive adhesive. Use of DERMABOND™ PRINEO™ System on patients with hypersensitivity to one of these components
may lead to skin reaction. Do not use on mucosal surfaces or across mucocutaneous junctions (e.g., oral cavity, lips), or on
skin that may be regularly exposed to body luids or with dense natural hair (e.g., scalp).
Wound Preparation
The skin edges must be closely approximated prior to application of the mesh, so that
no signiicant manual approximation is required during mesh application. When used
in high-tension areas, ensure skin tension has been removed by application of another
wound-closure device (e.g., sutures or skin staples) prior to application of DERMABOND™
PRINEO™System, or ensure that the area will be immobilized during the skin-healing period.
Mesh Application
Position the mesh so one half is on
either side of the incision, ensuring
that at least 1 cm of mesh extends
from each end of the incision. Press
gently to ensure intimate contact of
the mesh to the side of the incision.
Gently pull the mesh perpendicularly
over the incision while adjusting
with ingers or forceps to achieve
skin-edge approximation, and aix
the remainder of the mesh to the
other side of the incision.
Liquid Adhesive Application
Apply the liquid adhesive using
short strokes and moving from one
end of the mesh to the other, making
sure that the mesh is saturated as
the liquid adhesive is applied. Spread
the adhesive smoothly and evenly
over the entire length of the mesh
using the lexible applicator tip.
DO NOT APPLY A SECOND COAT.
Knee Application
During a total knee arthroplasty,
best practice is to apply the
DERMABOND™ PRINEO™ System
while the knee is at the same angle of
lexion as the joint capsule closure,
without relaxing the knee.
ODP
Quick Guide
Skin/Wound
Preparation
Mesh
Application
Liquid Adhesive
Application
Postoperative
Care
Removal
Instructions
DERMABOND™ PRINEO™ Skin Closure System (22 cm)
Device Performance
Quick Guide1

The application of DERMABOND™PRINEO™System requires
thorough wound cleansing. Follow standard surgical practice for
wound preparation before application of DERMABOND™ PRINEO™
System (i.e., cleanse, irrigate, debride, obtain hemostasis, and close
deep layers such that there is no tension on the skin edges).
The skin edges must be closely approximated prior to application
of the mesh, so that no signiicant manual approximation is required
during mesh application.
When used in high-tension areas, ensure skin tension has been
removed by application of another wound-closure device
(e.g., sutures or skin staples) prior to application of DERMABOND™
PRINEO™ System, or ensure that the area will be immobilized
during the skin-healing period.
Pat the wound dry with dry, sterile gauze to ensure direct tissue
contact for adherence of the mesh and the liquid topical skin
adhesive to the skin.
DERMABOND™ PRINEO™ Skin Closure System (22 cm)
Skin/Wound Preparation1
ODP
Quick Guide
Skin/Wound
Preparation
Mesh
Application
Liquid Adhesive
Application
Postoperative
Care
Removal
Instructions

DERMABOND™ PRINEO™ Skin Closure System (22 cm)
Mesh Application1
Step 1
Remove the mesh patch from the mesh carrier and dispose
of the mesh carrier.
Step 2
Flatten the mesh patch at the crease gently. Place the mesh patch
lat on a surface so the mesh is facing down. Remove the center
paper liner by peeling from the tab while the patch is lat, with the
mesh side facing downward.
Step 3
Hold the mesh by the proximal (closest to you) corners of the
backing paper, ensuring the pressure-sensitive adhesive will be
on the mesh side that will be adhered to the patient’s skin.
Step 4
Position the mesh so one half is on either side of the incision,
ensuring that at least 1 cm of mesh extends from each end of
the incision. Press gently to ensure intimate contact of the mesh
to the selected side of the incision.
Gently pull the mesh perpendicularly over the incision while
adjusting with ingers or forceps to achieve skin-edge approximation,
and aix the remainder of the mesh to the other side of the incision.
Step 5
Use sterile scissors to trim any excess mesh, if necessary.
Remove the remaining paper backing/frames.
ODP
Quick Guide
Skin/Wound
Preparation
Mesh
Application
Liquid Adhesive
Application
Postoperative
Care
Removal
Instructions

DERMABOND™ PRINEO™ Skin Closure System (22 cm)
Liquid Adhesive Application1
Step 6
Activate the liquid adhesive applicator by twisting the purple dial
until a snap is heard.
Step 7
Position the applicator tip straight down and away from the
application area. Pinch the tip of the applicator, and squeeze the
lexible bulb one time. Once the pressure in the bulb is released,
it will partly or completely ill with liquid topical skin adhesive.
Step 8
Spread the liquid adhesive smoothly and evenly over the entire
length of the mesh using the lexible applicator tip.
Apply the liquid adhesive using short strokes and moving from
one end of the mesh to the other, making sure that the mesh is
saturated as the liquid adhesive is applied along the entire length.
Step 9
The adhesive should also be applied slightly over the edge of the
mesh, covering a small margin of surrounding skin. Any excess
liquid adhesive can be wiped o quickly with sterile gauze.
DO NOT APPLY A SECOND COAT.
Ensure the mesh is in intimate contact with the skin prior to application of the liquid adhesive.
The liquid adhesive should be applied over the mesh immediately after the mesh has been placed.
Although not necessary, a protective, dry wound dressing such as gauze may be applied only after the liquid adhesive
has completely polymerized (approximately 60 seconds), and the DERMABOND™ PRINEO™ System is no longer tacky to
the touch.
ODP
Quick Guide
Skin/Wound
Preparation
Mesh
Application
Liquid Adhesive
Application
Postoperative
Care
Removal
Instructions

DERMABOND™ PRINEO™ Skin Closure System (22 cm)
Postoperative Care1
Once polymerized, DERMABOND™ PRINEO™ System
provides a lexible microbial barrier with 99% protection
in vitro for 72 hours against organisms commonly
responsible for surgical site infections (SSIs).2
Patients should be advised that DERMABOND™ PRINEO™ System will need to remain
in place until the wound/incision is properly healed (typically 7 to 14 days). During this
time, DERMABOND™ PRINEO™ System should be kept dry.
If directed by the health care practitioner, the wound may be briely wet in a shower
or bath, if dried immediately thereafter by gently blotting with a soft towel. The wound
should not be soaked or scrubbed. Patients should not swim or otherwise immerse
the wound in water for prolonged periods.
If a protective wound dressing is being used over DERMABOND™ PRINEO™ System,
it should be replaced with a dry dressing after showering or bathing.
Patients should also be instructed not to scratch, rub,
or pick at the DERMABOND™PRINEO™System and
reminded not to apply topical ointments, lotions, or
liquids to the wound while DERMABOND™PRINEO™
System is in place. This may loosen the DERMABOND™
PRINEO™System, causing it to peel away from the
skin before the wound has fully healed.
Patients should be instructed not to engage in
strenuous physical activity that may cause tension
on the wound or cause perspiration to wet the
DERMABOND™ PRINEO™ System.
ODP
Quick Guide
Skin/Wound
Preparation
Mesh
Application
Liquid Adhesive
Application
Postoperative
Care
Removal
Instructions

DERMABOND™ PRINEO™ Skin Closure System (22 cm)
Removal Instructions1
DERMABOND™ PRINEO™ System is designed to naturally slough o,
or it can be removed by following the removal instructions below.
Gently grasp the edge of the DERMABOND™ PRINEO™ System at one end of the wound. If the edge of the device
is still adhered to the skin, gently pick at the edge until it begins to peel away from the skin.
Slowly peel the DERMABOND™ PRINEO™ System away from the skin along the line of the wound, close to the skin.
Do not pull the mesh straight up from the skin. Use the other hand to stabilize the wound as the mesh is peeled o.
If required, petroleum jelly may be applied to aid in removal.
Any residual adhesive and/or dried wound exudate can be cleaned from the skin according to usual practice.
Please refer always to the Instructions for Use / Package Insert that come with the
device for the most current and complete instructions.
References
1. DERMABOND™ PRINEO™ Skin Closure System (22 cm) Instructions for Use.
2 Ethicon Inc, 06TR071, Study Report for in vitro evaluation of microbial barrier properties of DERMABOND ProTape, Dec 2006, Data on File
© Ethicon Endo‐Surgery (Europe) GmbH 2017, 072540-170509 EMEA
Ethicon Endo‐Surgery (Europe) GmbH
Hummelsbütteler Steindamm 71
22851 Norderstedt, Germany
www.ethicon.com
ODP
Quick Guide
Skin/Wound
Preparation
Mesh
Application
Liquid Adhesive
Application
Postoperative
Care
Removal
Instructions