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CONFIDENTIAL

A-B Tech Comm College Ethicon In-Service – Sutures / Dermabond

Kurt PrewittEthicon Products Clinical Representative

1-800-888-9234, x1562

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Agenda

• Ethicon

• Sutures– Absorbable and Non-Absorbable

– Needles

• New Innovations– Vicryl Plus

– Dermabond ProPen

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Definitions

• Suture– Term for material used to align severed body tissue together;

to hold in place while healing occurs

• Ligature or tie– A strand of suture material that is used to:

• Tie off blood vessels

• Prevent hemorrhage/bleeding

• Isolate tissue while excising

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2000 BC Ancient Egyptians

460 BC – 1865 AD Cauterize to ligation

1887 Silk and Cat Gut

1930s Commercial manufacturing

1940s Sterilization and uniformity

1950s Individualized packaging

1947 Nylon

1958 MERSILENE*polyester fiber

1969 PROLENE*polypropylene Suture

1974 VICRYL*(polyglactin 910) Suture

1976 ETHIBOND* polyester Suture

1979 Coated VICRYL*(polyglactin 910)

1989 PDS II* (polydioxanone) Suture

1992 ETHIGUARD*blunt point needle

1993 MONOCRYL* (poliglecaprone 25) Suture

1995 VICRYL Rapide* (polyglactin 910) Suture

1996 Dyed MONOCRYL* (poliglecaprone 25) Suture

1998 DERMABOND*Topical Skin Adhesive

2003 Coated VICRYL Plus* Antibacterial (polyglactin 910) Suture

2006 PDS and MONOCRYL Plus* Antibacterial Sutures

History of Suture Innovation

•Trademark

•Data on file, ETHICON, Inc.

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Critical Wound Healing Period

Skin

Mucosa

Subcutaneous

Peritoneum

Fascia

0 5 7 14 21 28 days

5-7 Days

5-7 Days

7-14 Days

7-14 Days

14-28 Days

Tissue Healing Times

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• Age

• Weight

• Nutrition

• Dehydration

• Blood Supply

• Immune response

• Chronic diseases

• Localized infection

• Diabetes

• History of Radiation Therapy

The Critical Wound Healing Period Can Depend on Various Factors

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Suture Sizes• Sizes range from 7 (Largest) to 11-0 (Smallest)

• Size 7-0 is the size of a human hair

• Example – General Closure– Fascia – Size 1 to 2-0

– Fat – Size 2-0 to 4-0

– Skin – Size 3-0 to 5-0

Wound Epidermis

Dermis

Subcutaneous (Fat)

Fascia

Slow Healing

Fast Healing Epidermis

Dermis

Subcutaneous (Fat)

Fascia

Cutting NeedlesTaper

Needles

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Box clearly distinguishes the type of suture and needle information

• Code

• Suture size

• Product name

• Suture length

• Needle size

• Type of needle

• Quantity

ETHICON Products Box

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Suture Types

Absorbable Non-Absorbable

Natural SyntheticNatural Synthetic

Short-Medium -term

Medium -term

Longer -term

Monofilament Braided

Short -term

Monofilament Braided

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Suture Summary

• Braided– Vicryl– Vicryl Plus– Vicryl Rapide

• Monofilament– Monocryl– PDS II– Plain Gut - Natural– Chromic Gut - Natural– Fast Absorbing Gut - Natural

• Braided– Silk - Natural– Cotton - Natural– Nurolon– Mersilene– Ethibond Excel

• Monofilament– Prolene– Ethilon– Stainless Steel - Natural

Absorbable Non-Absorbable

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Suture Types

Absorbable

Natural Synthetic

Short-Medium -term

Medium -term

Longer -term

Short -term

Monofilament Braided Monofilament Braided

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Short-term Wound Support

Situation in Short-term Wound Support• Skin & mucosa• Typically emergency procedures• Typically areas with increased blood flow

Need Benefit• Fast-absorbing suture · Good clinical outcomes• Rapid loss of strength/mass• Good knot formation/snug down

Procedure Example: Episiotomy & Perineal Repair

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ETHICON Products Gut SutureAll Gut is not created equal» ETHICON Products Surgical Gut sutures are manufactured from almost

100% pure collagen: (i.e. small intestine of sheep or serosa of cattle) Quality in raw material which minimizes tissue reactions.

» TRU-GAUGING is an exclusive ETHICON process which produces the most uniform diameter possible: No fraying of the suture after tie-down

» Buffered CHROMICIZING the entire suture is an exclusive ETHICON process which minimizes tissue irritation.

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Coated VICRYL RAPIDE* (polyglactin 910) Suture

SYNTHETIC Predictable absorption

Minimal tissue reaction

FAST ABSORPTION No foreign body after 6 weeks Superficial sutures brush off after

7-10 days

BRAIDED Good handling & knotting

Initial strength greater than nylon

& gut suture

COATING Smooth passage through tissue. Easy knot adjustment

For delicate repairs the comfort of a synthetic alternative to gut suture

•Trademark

* Data on file, ETHICON, INC

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Short-Medium-term Wound Support

Situation in Short-Medium-term Wound Support• Skin, mucosa, subcuticular• Typically cosmetic surgery cases• Typically areas with increased blood flow

Need Benefit High initial strength · Good Clinical

Outcomes• Good cosmesis• Good handling & passage through tissue• Good knot formation/snug down• Low reactivity

Procedure Example: Plastic Surgery

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MONOCRYL* (polyglecaprone 25) Suture

SYNTHETIC Predictable absorption

Minimal tissue reaction

MONOFILAMENT Smooth passage through tissue

POLIGLECAPRONE 25 Excellent handling characteristics and pliability

Excellent knot security

Monofilament pliability unprecedented among synthetic absorbable suture

•Trademark

•* Data on file, ETHICON, INC

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Medium-term Wound Support

Situation in Medium-term Wound Support• All tissue layers that align with the critical wound healing period of 21-28

days• All tissue types

Need Benefit• Consistent strength around the CWHP · Good clinical

outcomes• Good handling & passage through tissue• Good knot formation/snug down• Low reactivity Procedure Example: General Closure

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Coated VICRYL* (polyglactin 910) Suture

SYNTHETIC Predictable absorption

Minimal tissue reaction

ABSORBABLE No foreign body after 56-70 days

Strength in the critical wound healing time with new claim of 25% BSR at 28 days

BRAIDED Strong good handling & knotting

COATING Smooth passage through tissue. Minimal tissue trauma Unique coating enables knot adjustability

Unequaled strength from the worlds #1 Suture

•Trademark

Data on file, ETHICON, INC.

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Longer- term wound support

Situation in Longer-term Wound Support• Tissue that requires extended support• Friable tissue• Slow healing tissue/ compromised patients• Typically fascia tissue

Need Benefit• Strength beyond the CWHP of 21 days · Good clinical

outcomes• Good handling & passage through tissue• Good knot formation/snug down• Low reactivity

Procedure Example: Body Contouring

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PDS II * Suture (polydioxanone) sutureSYNTHETIC Predictable absorption

Minimal tissue reaction

MONOFILAMENT Smooth passage through tissue

Initial strength greater than nylon & gut suture

POLYDIOXANONE Prolonged wound support

High initial strength

Good handling characteristics

Knot security

PRODUCT OFFERING Looped suture for speed and security of long incision fascia closure

Strongest synthetic absorbable suture for extended wound support

•Trademark

Data on file, ETHICON, INC.

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Suture Types

Non-Absorbable

SyntheticNatural

Monofilament BraidedMonofilament Braided

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PROLENE* (polypropylene) Suture

SYNTHETIC Minimal tissue reaction even in the presence of infection

MONOFILAMENT Smooth passage through delicate tissue

POLYPROPYLENE Will not fatigue with flexingProvides permanent wound supportUnique knotting properties

MANUFACTURING Highly controlled PROCESS Numerous quality checks

Controlled linear elongationConsistent suture, strand- to-strand

*Trademark

Data on file, ETHICON, INC.

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ETHIBOND EXCEL* (polyester) Suture

SYNTHETIC Minimal tissue reaction

BRAIDED 30% Stronger than leading competitor (size 2/0)Good handling & knotting15% stronger than ever beforeCentral core provides strong suture

POLYESTER Provides permanent wound support

POLYBUTILATE Smooth knot tie-down

COATING Excellent handling propertiesUnmatched polyester knot security

*Trademark

Data on file, ETHICON, INC.

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PERMA-HAND* Silk SutureBRAIDED Excellent handling and knotting

characteristics

WAX COATING Improved surface qualitiesReduces capillarity

INDICATIONS Used in a wide variety of surgical procedures

*Trademark

Data on file, ETHICON, INC.

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ETHILON* (nylon) sutureMONOFILAMENT Smooth, easy passage through tissue

NYLON Less tissue reactionProvides long term wound support

PLIABILIZED Ease of handling

OFFERING Less package memory

INDICATIONS Used in a wide variety of proceduresFine sizes specifically for use in

ophthalmic and microsurgery

*Trademark

Data on file, ETHICON, INC.

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NUROLON* Nylon Suture

» Specially made for neurological surgery

» Handles like silk

» Higher strength and less tissue reaction than silk

•T*Trademark

Data on file, ETHICON, INC.

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Cotton and Steel

• Cotton– Natural cellulose multifilament fiber– Weakest of non-absorbable materials, but gains strength when wet– Used for ligating and suturing– No advantages over silk

• Steel– Inert with high tensile strength– Used for sternum closure, orthopedics, neurosurgery– May be used in presence of infection– Difficult to handle and tie. May damage tissue.– Be Careful! Keep straight, double glove, use wire cutters

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Advanced Needle Technology

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ETHICON Products Box

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The Anatomy of the Ideal Surgical Needle

• Three key factors make up the ideal needle:– Alloy

– Geometry – tip and body

– Coating

• The combination of these attributes is ETHICON’s Advanced Needle Technology

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GEOMETRY

TIP BODY

Various designs for surgical indication

• PRIME* cutting – for skin closure• BV Taper – vascular anastomosis• ETHIGUARD* Blunt – safety needles• CS Ultima* – spatulated ophthalmic• V-Series – penetrating taper tough tissue

Designed for ease of use

• Needle Ribs – stability in needle holder• BV – rounded geometry for arming flexibility• 12:1 taper ratio – smooth passage, improved penetration• Laser Drilled – smooth needle – suture transition

Provides the appropriate penetration performance for surgical indication and maximizes ease of handling during surgery

Focus on Needle Geometry

•Trademark

Data on file, ETHICON, INC..

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Less mass than typical reverse cutting needle = improved penetration and control

An exclusive needle tip design that provides

• Precise placement• Smoother repeated passage • Better control• Less tissue trauma

Geometry-What is Prime?

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Coating - What is MultiPass*?

Proprietary new needle coating

Provides superior needle penetration performance consistency

• Pass after Pass

• Needle to Needle

• Through 30 needle passes

1st pass is not improved 5th, 10th, 20th and 30th are!

•*Trademark

Data on file, ETHICON, INC.

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Needles Shapes

¼ Circle 3/8 Circle ½ Curve

½ Circle 5/8 Circle Straight

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Needles Types

Taper Point Needle

ETHIGUARD* Blunt Point Needle

Conventional Cutting

Reverse Cutting

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Paper Folder 1990

PROLENE* suture Packaging Innovation

• Needles held in place by suture• Needle separation

• Automated process (More Consistent Handling of needles & sutures)

• Enhanced needle separation

• One step opening (no paper tear tab)• Needles held in park• Circulating & scrub nurse verify needle count• Recyclable plastic tray

Door Relay 1992

Zipper Relay 2000

* Trademark

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New Innovations

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Surgical Site Infection (SSI) FACTS

• 27 Million Procedures in the US

• 2%-3% Infection Rates

• 675,000 SSIs

• 66% Confined to Incision

• Staph a, Staph e, MRSA, MRSE

CONTRIBUTING FACTORS

• OR

• Procedure

• Technique

• Patient

• Implants

• And others

ROLE OF THE IMPLANT

• Three Key Factors

– Less Bacteria Required

– Microorganisms Can Colonize and Spread

– Biofilm Formation

• The Key - Preventing Bacteria Colonization

VICRYL Plus Inhibits Bacterial ColonizationRenders the suture neutralPotentially eliminates it from the SSI Equation

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FACTS TO REMEMBER

• VICRYL Plus Antibacterial Suture Creates a Zone of Inhibition

• VICRYL Plus Suture is Bacteriocidal

• VICRYL Plus Suture Is Effective Against Staph a, Staph e, MRSA, MRSE

• VICRYL Plus Suture Is Designed to Be Used Everywhere You Use VICRYL Suture

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FACTS TO REMEMBER

• Medical Implants, Such As Sutures, Do Not Cause Infection

• SSI Common Contributing Factors– Patient Profile– Surgical Technique– Surgical Environment – The Procedure Itself– Medical Implants

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» Competes with sutures and staples for skin closure

» Strong as 4-0 suture within 3 minutes

» Microbial barrier

» Cosmesis

» An occlusive dressing

» Fast and easy

» Patient satisfaction and comfort

» Close incisions up to 69 cm

» Patient friendly – Shower immediately, min post-op care

Topical Adhesives

•Trademark

Data on file, ETHICON, INC.

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» Over 300 sales reps hired and trained to service all hospital customers.

» Clinicians trained on new products / procedures.

» Suture utilization/standardization programs. (i.e., Inventory programs, returns, in-services)

» Key customer events (ie: symposiums, plant educational events, key customer visits).

ETHICON Products: Value Above Price

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A- B Tech Comm College

Thank you for your attention!

Questions ?

Kurt PrewittEthicon Products Clinical Representative

1-800-888-9234, x1562