Appendix: Wound care products

Therapeutic G oods A dministration The TGA classifies wound care products into four groups, with specific requirements applying to each group. Goods contained in Groups 1–3 require listing, while goods in Group 4 are exempt from listing. Further information can be obtained from: • Mail: TGA Communications Section, PO Box 100, Woden ACT 2606, Australia • Phone: –– 1800 020 653 (freecall within Australia) –– 02 6232 8610 (for publications enquiries) –– Users who are deaf or have a hearing or speech impairment can call through the National Relay Service: ** TTY or computer with modem users phone 1800 555 677 then ask for 1800 020 653 ** Speak and listen (speech-to-speech relay) users phone 1800 555 727 then ask for 1800 020 653 • Fax: 02 6232 8605 • Email: [email protected]

D ressings

products

Gauze and non-adherent pads Cutilin Interpose Mediam Melolin range Release Tegaderm Contact Layer Telfa range

Smith & Nephew Multigate Sentry Medical Smith & Nephew Johnson & Johnson 3M Covidien

Tricotex

Smith & Nephew

Impregnated contact layer Adaptic range Atraumann

Johnson & Johnson Paul Hartmann

2

WOUND CARE PRODUCTS

Cuticerin Curity Grassolind Hydrotul Jelonet Tegapore Urgotul range Vaseline gauze

Smith & Nephew Kendall Paul Hartmann Paul Hartmann Smith & Nephew 3M Link Medical Technologies / Urgo Medical Covidien/Kendall

Film dressings Bioclusive Cutifilm Hydrofilm range Mepitel Film Mepore range Opsite range Polyskin range Suprasorb F Tegaderm range

Johnson & Johnson Smith & Nephew Paul Hartmann Mölnlycke Mölnlycke Smith & Nephew Covidien/Kendall Lohmann & Rauscher 3M

Foam dressings Polyurethane Advasorb range Alione Allevyn range Askina range Activheal range Hydrasorb/Copa range SupraSorb P range Tegaderm Foam Trufoam range Urgotul range UrgoStart Versiva range

Advancis Medial Coloplast (hydrocapillary with hydrocolloid layer) Smith & Nephew (Hydrocellular) B Braun Trans-Pacific Healthcare Covidien (Kendall) Lohmann & Rauscher 3M Unomedical Urgo Medical / Link Medical Technologies (CMC) Urgo Medical/Link Medical Technologies Convatec (with hydrofibre and hydrocolloid border)

WOUND CARE PRODUCTS

Polyurethane hydroactive Biatain range Cavicare Cutinova Hydro+ PermaFoam range PolyMem range Tielle range Hydrogel Amorphous gel Activheal Burnaid Curafil range DuoDERM gel Hydrosorb range Hypergel Intrasite gel Normlgel Nu-Gel Purilon gel SAF-Gel SoloSite Solugel range Suprasorb G range Tegagel Urgo Hydrogel Woundaid Gel sheet ActiForm Cool Aquaclear range Aquaflo disc Askina gel Curagel sheet Hydrosorb range Nu-Gel sheet

Coloplast Smith & Nephew (Conforming silastic foam) Smith & Nephew (Hydro selective) Paul Hartmann Reliance Medical Johnson & Johnson

Trans-Pacific Healthcare Rye Pharmaceutical (Melaleuca oil) Covidien (Kendall) Convatec Paul Hartmann Mölnlycke Smith & Nephew Mölnlycke Johnson & Johnson Coloplast Convatec (preservatives added) Smith & Nephew (preservatives added) Johnson & Johnson L&R / Surgical House 3M Urgo Medical/Link Medical Technologies Rye Pharmaceuticals (Melaleuca oil)

L&R Surgical House Paul Hartmann Covidien (Kendall) B Braun Covidien (Kendall) Paul Hartmann Johnson & Johnson

3

4 

– Appendix

Impregnated gauze Burnaid Curafil gauze Intrasite conformable

Rye Pharmaceuticals Covidien (Kendall)

Gel coated HydroTac range

Smith & Nephew

Paul Hartmann

Hydrocolloid Activheal Algoplaque range Askina Biofilm Tansparent Comfeel range DuoDerm range

Trans-Pacific Healthcare Urgo Medical/Link Medical Technologies B Braun Coloplast Convatec (includes a stomadhesive and a woundcare product) Hydrocoll range Paul Hartmann Nu-Derm range Johnson & Johnson Replicare range Smith & Nephew Restore range Hollister Suprasorb H range Lohmann & Rauscher Tegaderm Hydrocolloid range 3M Ultec range Convidien (Kendall) Alginate Activheal range Trans-Pacific Healthcare Algisite M range Smith & Nephew Algoderm range Johnson & Johnson CalciCare Hollister Curasorb range Covidien (Kendall) Kaltostat range ConvaTec Melgisorb range Mölnlycke SeaSorb range Coloplast Sorbalgon range Paul Hartmann Sorbsan range Unomedical Suprasorb range L&R Tegaderm alginate range 3M Urgosorb range Urgo Medical/Link Medical Technologies



– Wound care products

5

Gelling Fibre Options available include combined with silver, foam, silicone, and hydrocolloid adhesive. Aquacel Extra range Convatec Durafiber range Smith & Nephew Silicone Scar management Caroskin Professional CiraCare KeloCote Mepiform Scarban Silicone gel

Mölnlycke Reliance Medical

Silicone contact Adaptic touch Advasorb range Askina range Mepilex range

Johnson & Johnson Advancis Medical B Braun Mölnlycke

Reliance Medical Smith & Nephew Advancis Medical/Medigroup

Silicone adhesive Allevyn Gentle range Smith & Nephew Allevyn Life Smith & Nephew Aquacel Border Form range Convatec Askina range B Braun Biatain range Coloplast Mepilex range Mölnlycke Dressings containing silver Acticoat range Actisorb Plus Allevyn Ag range Aquacel Ag range Arglaes range Atrauman Ag Biatain Ag range

Smith & Nephew Johnson & Johnson Smith & Nephew ConvaTec Unomedical Paul Hartmann Coloplast

Flamazine Mepilex Ag range Polymem Ag range

Smith & Nephew Mölnlycke Reliance Medical

6

WOUND CARE PRODUCTS

SilverCel range Vliwaktiv Ag

Johnson & Johnson Lohmann & Rauscher

Dressings containing iodine Betadine Braunol Inadine Iodosorb range

Mundipharma B Braun Systagenix (Johnson & Johnson) Smith & Nephew

Honey (medical grade) Medihoney range Activon range

Convita Advancis Medical

Antiseptic dressings AMD range Curity range Kerlix range Protosan range TenderWet with PHMB

Covidien (Kendall) Covidien (Kendall) Covidien (Kendall) B Braun (contains betaine surfactant) Paul Hartmann

Enzyme Alginogel Flaminal Hydro Flaminal Forte

Aspen Pharmacare Aspen Pharmacare

Isotonic dressings TenderWet range

Paul Hartmann

Hypertonic dressings Curasalt range Mesalt (dry) range Hypergel

Covidien Mölnlycke Mölnlycke

Acrylic dressings Tegaderm Absorbent

3M

Specialty absorbent dressings Curea Eclypse Foot Exudry Mesorb

Reliance Medical Advancis Medical Smith & Nephew Mölnlycke

WOUND CARE PRODUCTS

Relevo Vilwasorb Zetuvit range

Reliance Medical Lohmann-Rauscher Paul Hartmann

Dressings with capillary action/Hydroconductive Advadraw Advancis Medical (Medigroup) Vactuex range Medical Specialties (Protex) Hydrocapillary Alione

Coloplast

Hydrophobic interactive dressings Cutimed Sorbact range AMCLA, P/L Odour-absorbing dressings Actisorb Plus Carbonet Caroflex Lyofoam C Sorbsan Plus Carbon

Johnson & Johnson Smith & Nephew ConvaTec Aaxis Pacific Unomedical

Keratin Keragel and Keragel T Keramatrix Kerasorb

Catalyst Medical Catalyst Medical Catalyst Medical

Collagen products Biostep Cellerate RX

Smith & Nephew (not available, Australia) Hymed Group Corporation (not available, Australia) Smith & Nephew (not available, Australia) Johnson & Johnson Johnson & Johnson Johnson & Johnson Medline (not available, Australia) L&R Urgo Medical/Link Medical Technologies

7

8

WOUND CARE PRODUCTS

Negative

wound pressure therapy

Technologies available in Australia InfoV.A.C., ActiVA.C., V.A.C. ATS., V.A.C.Freedom (foam based), VAC, Veraflo KCI: www.kci-medical.com/kci/australia V1STA, EZCARE,(gauze based) RENASYS (choice of foam or gauze) Smith & Nephew: http://myrenasys.com/ products Disposable Prevena Vac Via PICO SNAP

KCI KCI S&N Spiracur

Biological

skin substitutes

Grafts and cutaneous flaps Classification

Origin

Tissue replaced

Duration

Layers

Brand name: Manufacturer

Allograft

Cadaver skin

Epidermal/ dermal

Temporary

Variable

*

Xenograft (porcine)

Porcine

Dermal

Temporary

Biosynthetic, acellular

EZ derm: Brennan Medical

Xenograft cutaneous flaps

Porcine

Epidermal/ dermal

Permanent

Variable

*

* available in Australia

Biosynthetic skin substitutes Tissue replaced

Duration

Brand name: Manufacturer/Distributor

Acellular de-epithelialised cadaver dermis

Dermal

Permanent

Alloderm: LifeCell

Acellular freeze-dried human dermal matrix

Dermal

Permanent

GraftJacket: Wright Medical Technology

Classification and type Biological

9

WOUND CARE PRODUCTS

Classification and type

Tissue replaced

Duration

Brand name: Manufacturer/Distributor

Porcine small intestine submucosa

Dermal

Temporary

Oasis: Healthpoint*

Bovine collagen and oxidised regenerated cellulose

Dermal

Temporary

Promogran: Johnson & Johnson

Epidermal

Temporary

Synthetic Polyurethane membrane

Omiderm: ITG Laboratories*

Mixed Neonatal keratinocytes, bovine collagen seeded with neonatal fibroblasts

Epidermal/ Temporary dermal

Apligraft: Organogenesis*

Silicone, nylon mesh, porcine polypeptides

Epidermal

Temporary

Biobrane: UDL Laboratories

Human fibroblasts seeded onto a bioabsorbable polyglactin mesh scaffold

Dermal

Permanent

Dermagraft: Advanced Tissue Sciences Inc.

Silicone, collagen and glycosaminoglycan

Dermal

Permanent

Integra: Integra Life Science*

Bovine collagen sponge seeded with allogenic fibroblasts and keratinocytes

Epidermal/ Permanent dermal

OrCel: Forticell Bioscience

Silicone, nylon mesh, collagen seeded with neonatal fibroblasts

Epidermal

Temporary

TranCyte: Advanced Tissue Sciences (Smith & Nephew)

Cultured autologous fibroblasts on biomaterial derived from hyaluronic acid

Dermal

Permanent

Hyalograft: Fiolia Advanced Biopolymers

* available in Australia

Autologous, cultured, and non-cultured engineered products Brand name: Manufacturer / Distributor

Tissue replaced

Duration

Cultured epithelium autograft

Dermal

Permanent

Cell Spray: Clinical Cell Culture*

Cultured autologous keratinocytes

Epidermal

Permanent

Epicel: Genzyme Tissue Repair

Generated in vitro from patient’s hair root cells

Epidermal

Permanent

EpDex: Modex Therapeutics

Classification and type Cultured keratinocytes

10

WOUND CARE PRODUCTS

Cultured autologous keratinocytes Hyaluronic acid with laser perforations

Epidermal

Permanent

Laserskin: Fidia Advanced Biopolymers

Autologous cell harvesting kit

Epidermal

Permanent

Recell: Clinical Cell Culture*

Epithelial autograft

Epidermal

Permanent

CellSpray XP: Clinical Cell Culture*

Non-cultured keratinocytes/ melanocytes

* available in Australia

M anufacturers

and distributors of wound care products

Company name

Australian contact number Website

3M

136 136

www.3m.com.au

Aaxis Pacific

(02) 9838 9588

www.aaxispacific.com.au

Advancis Medical

(03) 9706 3600

www.defries.com.au

Advantage Healthcare (Tally)

(03) 9580 9288

www.advantagehealthcare.com.au

AMCLA

(03) 9782 4777

www.amcla.com.au

Arjo-Huntleigh

1800 072 040

www.arjohuntleigh.com

Aspen Australia

(02) 8436 8300

www.aspenpharma.com.au

B.Braun Australia

1800 251 705

www.bbraun.com.au

Beta Healthcare

1800 025 551

www.polymem.com

Briggate Medical

(03) 9580 5377

www.briggatemedical.com

Bright Sky Australia

1300 88 6601

www.brightsky.com.au

Catalyst Medical

1800 820 621

www.catalystmedical.com.au

Clifford Hallum

1300 720 274

www.ch2.net.au

Clinical Cell Culture

(08) 9389 0700

www.avitamedical.com

Coloplast

1800 333 317

www.coloplast.com.au

ConvaTec

1800 335 276

www.convatec.com.au

Covidien (Kendall)

1800 252 467

www.kendallhq.com/ kendallhealthcare

Convita (Medihoney)

1800 466 392

www.medihoney.com

Defries Industries

1300 550 278

www.defries.com.au

Hollister

1800 335 276

www.hollister.com/anz



WOUND CARE PRODUCTS

Company name

Australian contact number Website

Independence Australia

1300 788 855

www.independencesolutions.com. au

Johnson & Johnson

1800 252 194

www.jnj.com.au

KCI Medical

1800 815 529

www.kci-medical.com

Lohmann & Rauscher

See Sentry Medical or Surgical House

MacMed Healthcare

1300 308 184

www.macmedhealthcare.com

McFarlane Medical

(03) 9836 7777

www.mcfarlanemedical.com.au

MediGroup

1300 362 534

www.medigroup.com.au

Mölnlycke

1800 005 231

www.molnlycke.com

Multigate

1800 023 420

http://multigate.com.au/main.htm

Paul Hartmann

1800 805 839

www.hartmann.com.au

Pegasus Healthcare

1300 303 603

www.pegasushealthcare.com

Reliance Medical

1800 280 133

www.reliancemedical.com.au

Rye Pharmaceuticals Australia

(02) 9417 1922

www.ryepharmaceuticals.com

Sentry Medical

1300 995 999

www.sentrymedical.com.au

Smith & Nephew

13 13 60

www.smith-nephew.com

Surgical House

(08) 9381 4199

www.surgicalhouse.com.au

Sutherland Medical

(03) 9530 9988

www.sutherlandmedical.com.au

Trans-Pacific

(03) 9885 0300

www.tphc.com.au

Unomedical

(02) 9997 8033

www.unomedical.com

Urgo Medical / Link Medical Technologies

(02) 8401 9777

www.linkmedicaltechnologies.com. au

11