DermaBlue eBook test version

Inachangedworld,worksmarter withthepowerof Broadspectruman microbial protec oninaready-to-use, highlyabsorbentfoamdressing TheCombined •Sustainedbroadspectrum antimicrobialeffectiveness 33EffectivenessOf Antimicrobials •Highlyhydrophilic-capillarywicking actiondrawsexudatevertically MethyleneBlue GentianViolet •Twoabsorbencyoptions Silver •Readytouse-nohydrationneeded •Upto3dayweartime •Compatiblewithothercommon woundtreatmentoptions DermaBlue+Foam andDermaBlue+Foam Transferarehighlyabsorbentfoamdressingswiththree provenmicrobe-fightingingredients-methyleneblue,gentianviolet,andsilver-forbroadspectrum antimicrobialandantifungalprotectionwithinthedressing. Learnmoreatdermarite.com/dermablue orcall800-337-6296today. ©2020DermaRiteIndustries,LLC.

THE POWER OF PLUS The Foam With Three Antimicrobial Ingredients DermaBlue+™ Foam and DermaBlue+™ Foam Transfer Wound Dressings are polyurethane/polyether foam dressings infused with Methylene Blue (up to 0.25 mg/g), Gentian Violet (up to 0.25 mg/g), and Silver Sodium Zirconium Phosphate (up to 7 mg/g). DermaBlue+ uses a proprietary manufacturing process to bind these three ingredients to the foam, providing broad spectrum antimicrobial and antifungal protection within the dressing. Independent lab tests have shown the ingredients in DermaBlue+ to have superior antimicrobial benefits over a dressing with methylene blue and gentian violet alone.1 Methylene Blue • Historically proven antimicrobial effectiveness.2 • Effective against a wide range of bacteria and fungi. Gentian Violet • Antibacterial and antifungal properties. • Effective against gram positive and gram negative bacteria. Silver Ions • Noncytotoxic broad spectrum antimicrobial activiity.3 • Silver ions (Ag+) are activated in the dressing in an amount proportionate to the level of exudate. 2 dermarite.com |

The DermaBlue+ Foam Advantage • Highly absorbent, flexible, light weight, comfortable and resilient. • Combined antimicrobial effectiveness of methylene blue, gentian violet and silver. • Ready to use and easy to apply - no need to hydrate before use. • Uniquely designed to retain the color within the foam - ingredients won’t wash away, and no unwanted skin discoloration. • Compatible with other common treatment options. FEATURES & BENEFITS • Broad spectrum antimicrobial activity kills microbes in exudate absorbed in the dressing for up to 3 days: - Minimizes wound bed disruption. • Highly absorbent foam maintains a moist wound environment and facilitates autolytic debridement: - Protects skin from maceration. • Effective for use during all stages of wound healing. • Non-bordered, highly conformable dressing can be cut to fit, layered, and can be used for wounds with tunneling or undermining. | dermarite.com 3

Rev. 2019-02-19 • Sustained broad spectrum antimicrobial/antifungal protection within the dressing. • Up to 3 day wear time. • Ready to use - no need to hydrate. • Can be cut to fit, layered, and can be used for wounds with tunneling or undermining. • Suitable for moderately to heavily exuding • Thinner profile for managing wounds with wounds. less exudate. • Highly absorbent foam helps prevent • Highly hydrophilic - capillary wicking action maceration. draws exudate vertically. • Protects and cushions the wound. • Conforms easily to awkward to dress areas. DermaBlue+ Foam is indicated for moderate to heavily exuding DermaBlue+ Foam Transfer is indicated for moderately exuding, partial to full thickness wounds, including: pressure ulcers, leg ulcers, partial to full thickness wounds, including: pressure ulcers, leg ulcers, diabetic foot ulcers, graft wounds and donor sites, skin tears, first and diabetic foot ulcers, graft wounds and donor sites, skin tears, first and second degree burns, surgical wounds, lacerations and abrasions. second degree burns, surgical wounds, lacerations and abrasions. Product Size Reorder # Units Product Size Reorder # Units DermaBlue+ Foam 2x2 76020214 10/Box DermaBlue+ Foam Transfer 2x2 76020218 10/Box DermaBlue+ Foam 4x4 76040414 10/Box DermaBlue+ Foam Transfer 4x4 76040418 10/Box DermaBlue+ Foam 4x4 72040414 20/Box DermaBlue+ Foam Transfer 4x5 76040518 10/Box ©2019 DermaRite Industries, LLC. All rights reserved. DermaBlue+ Foam 4x5 76040514 10/Box DermaBlue+ Foam 8x16 75081614 5/Box For a sample or to place an order, please contact your sales representative, call 1-800-337-6296, or email [email protected] 1. Data on file. DermaRite Industries, LLC, 2019. 2. Edwards K. (2016). New Twist on an Old Favorite: Gentian Violet and Methylene Blue Antibacterial Foams. Advances in wound care, 5(1), 11-18. 3. Data on file. DermaRite Industries, LLC, 2019.

DESCRIPTION CHANGING THE DRESSING: DermaBlue+ Foam Wound Dressing is made of polyurethane/polyether • Dressing may be left in place for up to 3 days or as directed by a foam, Methylene Blue (up to 0.25 mg/g), Gentian Violet (up to 0.25 qualified healthcare professional. mg/g), and Silver Sodium Zirconium Phosphate (up to 7 mg/g). The 3 ingredients provide broad spectrum antimicrobial protection within the • Change the dressing if drainage shows through the back of the cover dressing. dressing; or if the edge of the cover dressing becomes loose; or if the condition of the wound or surrounding skin causes concern; or as INDICATIONS FOR USE directed by a qualified healthcare professional. DermaBlue+ Foam is indicated for moderately to heavily exuding, partial • Dressing may be moistened to ease removal. to full thickness wounds, including: pressure ulcers, leg ulcers, diabetic • Carefully remove adhesive secondary dressings by holding the edge foot ulcers, graft wounds and donor sites, skin tears, first and second degree burns, surgical wounds, lacerations and abrasions. of the dressing and slowly pulling it parallel to the skin. • Dispose of in accordance with local guidance. CONTRAINDICATIONS WARNINGS DermaBlue+ Foam should not be used on patients with a known sensitivity to silver or any other contents of the dressing. Not indicated • For single use only. for third-degree burns. • If signs of infection are detected, a qualified healthcare professional DIRECTIONS (Use under the guidance of a qualified healthcare should be contacted to decide on the next course of action. professional.) • If signs of an allergic reaction are detected, discontinue use of the PREPARE WOUND SITE AND SURROUNDING SKIN: product and seek advice from a qualified healthcare professional. • Product is sterile unless the package is opened or damaged. Do not 1. Cleanse wound to remove residue according to local infection control protocol. resterilize. 2. Skin around wound should be clean and dry, use skin barrier prep OTHER INFORMATION as needed. • Store in a dry place at room temperature. TO APPLY: • Keep away from sunlight. • Not made with natural rubber latex. 1. Remove dressing from package. 2. Dressing may be cut to size prior to application. Dressing may be Caution: Federal (USA) law restricts this device to sale by or on the order of a physician (or properly licensed healthcare practitioner). rolled or layered to lightly pack into wound. 3. Apply dressing directly to wound. Direct contact with entire wound bed is necessary for best results. 4. Secure with tape or appropriate cover dressing that manages drainage and maintains a moist wound environment. DEPTH / STAGE ABSORBENCY PARTIAL | FULL HIGH 234 For Partial and Full thickness wounds / Pressure ulcers stages 2-4 Manufactured for DermaRite Industries LLC Rx Only North Bergen, NJ 07047 • 800.337.6296 www.dermarite.com 222036 | REV. 2018-10-24

DESCRIPTION CHANGING THE DRESSING: DermaBlue+ Foam Transfer is a thin foam wound dressing that is highly • Dressing may be left in place for up to 3 days or as directed by a hydrophilic. DermaBlue+ Foam Transfer is made of polyurethane/ qualified healthcare professional. polyether foam, Methylene Blue (up to 0.25 mg/g), Gentian Violet (up to 0.25 mg/g), and Silver Sodium Zirconium Phosphate (up to 7 mg/g). • Change the dressing if drainage shows through the back of the cover The 3 ingredients provide broad spectrum antimicrobial protection within dressing; or if the edge of the cover dressing becomes loose; or if the dressing. the condition of the wound or surrounding skin causes concern; or as directed by a qualified healthcare professional. INDICATIONS FOR USE • Dressing may be moistened to ease removal. DermaBlue+ Foam Transfer is indicated for moderately exuding, partial • Carefully remove adhesive secondary dressings by holding the edge to full thickness wounds, including: pressure ulcers, leg ulcers, diabetic foot ulcers, graft wounds and donor sites, skin tears, first and second of the dressing and slowly pulling it parallel to the skin. degree burns, surgical wounds, lacerations and abrasions. • Dispose of in accordance with local guidance. CONTRAINDICATIONS WARNINGS DermaBlue+ Foam Transfer should not be used on patients with a • For single use only. known sensitivity to silver or any other contents of the dressing. Not • If signs of infection are detected, a qualified healthcare professional indicated for third-degree burns. should be contacted to decide on the next course of action. DIRECTIONS (Use under the guidance of a qualified healthcare • If signs of an allergic reaction are detected, discontinue use of the professional.) product and seek advice from a qualified healthcare professional. PREPARE WOUND SITE AND SURROUNDING SKIN: • Product is sterile unless the package is opened or damaged. Do not 1. Cleanse wound to remove residue according to local infection control resterilize. protocol. OTHER INFORMATION 2. Skin around wound should be clean and dry, use skin barrier prep as needed. • Store in a dry place at room temperature. • Keep away from sunlight. TO APPLY: • Not made with natural rubber latex. 1. Remove dressing from package. Caution: Federal (USA) law restricts this device to sale by or on the 2. Dressing may be cut to size prior to application. Dressing may be order of a physician (or properly licensed healthcare practitioner). rolled or layered to lightly pack into wound. 3. Apply dressing directly to wound. Direct contact with entire wound bed is necessary for best results. 4. Secure with tape or appropriate cover dressing that manages drainage a nd maintains a moist wound environment. Manufactured for DermaRite Industries LLC Rx Only North Bergen, NJ 07047 • 800.337.6296 www.dermarite.com 222036 | REV. 2018-10-24

Content adapted from the original publication to change the product name used in the study, from RTD Dressing to DermaBlue+ Foam. No data or conclusions have been altered in these materials. Treatment of a Complex Diabetic Foot Wound with DermaBlue+ Foam™ Wound Dressing*: A unique absorbent antimicrobial polyurethane foam dressing Dr. Belinda Marcus, MD, FACEP, CWS, Medical Director, North Fulton Hospital, Roswell, GA and Kathy Kaufman, LPN, CHT, Wound Care Nurse, HyperbaRXs at Northside Forsyth, Cumming, GA Introduction Initial Assessment (15 mo. wound) This 71 y/o female patient presented to wound clinic with a large 15 month old wound on the lateral aspect of the ankle and dorsum of Week 6 (Prior to DB+) the foot. Wound cultured positive for P.aeruginosa, MRSA, and E. coli with etiology related to atherosclerosis. Patient has a complicated medical history including Diabetes, Hypertension, Lupus, Crohn’s disease, Fibromyalgia, Spinal Stenosis and previous lower extremity Pyoderma Gangrenosum. The patient has a history of systemic immunosuppressant therapy. Previous treatment included multiple oral antibiotics, systemic antibiotics, and debridement. The purpose of this study is to demonstrate the benefits of DermaBlue+ Foam Wound Care Dressing in managing these large lower extremity wounds complicated by a complex medical history, including diabetes and autoimmune disease. This dressing is the only one on the market that contains all three known antimicrobials integrated into the foam matrix: methylene blue (0.25 mg/g) and gentian violet (0.25 mg/g) plus a silver compound (Silver Zirconium Phosphate (7 mg/g). This dressing provides sustained antimicrobial protection and is effective against a broad spectrum of gram negative and gram positive bacteria, yeast and fungi. It is a more effective antimicrobial than dressings that contain organic pigments (methylene blue and gentian violet) alone (1). Method Wound measurements were recorded on each visit. Initially the patient was managed for 6 weeks with oral antibiotics, debridement, compression and advanced wound care dressings including: Silvaklenz™/Silvion™, Enluxtra™, Drawtex® and Cutimed®. DermaBlue+ Foam was started, in addition to oral antibiotics, due to an increase in wound size, exudate and foul odor with prior treatment. Percent wound surface area reduction was calculated and monitored following the commencement of DermaBlue+ Foam wound dressing. The patient received treatment with a cryopreserved amniotic cell injection 5 months into her treatment. *At the time of this study DermaBlue+ Foam was sold under the name “RTD Wound Dressing”. Learn more about DermaBlue+™ Foam at dermarite.com or call 1-800-337-6296

Content adapted from the original publication to change the product name used in the study, from RTD Dressing to DermaBlue+ Foam. No data or conclusions have been altered in these materials. Results The wound measurement was 8.0 x 9.0 x 0.2 cm (72 cm2) at the time that DermaBlue+ Foam wound dressing was initiated. Percent wound surface area reduction (WSAR) in 4, 8 and 12 weeks was 26% (53.6 cm2), 53% (34.1 cm2), 84% (11.34 cm2), respectively. The wound continues to heal gradually. The wound measured 2.2 x 1.1 x 0.1cm at 7 months post DermaBlue+ Foam and was reduced to 2.42 cm2 (97% WSAR). Discussion 4 Weeks with DB+ -26% WSAR 8 Weeks with DB+ -53% WSAR DermaBlue+ Foam helped to control the wound bed contami- nation and reduce the surface bioburden. The wound began healing despite the fact that it was frequently complicated by infection through out treatment. DermaBlue+ Foam has been shown to be effective in reducing commonly found wound bacteria (2). Since this new dressing possesses absorptive and antimi- crobial properties, it creates an optimal environment for wound 12 Weeks with DB+ -84% WSAR 7 Months with DB+ -97% WSAR healing and helps to overcome the challenges of a compromised wound-healing environment such as this. Since the silver com- pound in this dressing is non cytotoxic, this dressing could be used throughout the continuum of healing. Conclusion This 76 year old patient was immunosuppressed and had a very complicated medical history, including Diabetes, Hypertension, Lupus, Crohn’s disease, Fibromyalgia, Spinal Stenosis and Pyoderma Gangrenosum. The outcome with DermaBlue+ Foam was very positive with 84% WSAR in after 12 weeks. This dressing appeared to help “kick start” the healing process where other dressings were not as effective. This complex chronic wound continues to improve with the use of DermaBlue+ Foam wound dressing. References: 1) Data on file. 2) Achterberg J, Abboud L. Case Closed: Opening the door to closing challenging wounds.Ostomy Wound Manage.2014;61(3):12-14. Learn more about DermaBlue+™ Foam at dermarite.com or call 1-800-337-6296





AGreatToolFor InteractiveDressing SelectionGuideApp Telehealth DermaRite’sinteractivedressingguide TheDermaRiteAppisagreatresourcefor isauniquedigitalcatalogthatallows clinicianswho need to communicate with userstoinputwoundinformationtosee patientsandcaregiversviatelemedicine. whichDermaRitedressingsaresuitedfor usewiththatwound. ThisfreeInteractiveWoundDressingSelection Guidecanhelpclinicianstochoosetheright AvailableforiPhone,iPad&Android. typeofdressingforawound,anditprovides informationaboutavarietyofdressingtypes. LearnmoreaboutDermaRiteproductsandservices atdermarite.comorcall800-337-6296today. ©2020DermaRiteIndustriesLLC.Thecontentintheappisprovidedforeducationalandinformationalpurposesonlyandshouldnotbeconsideredmedicaladviceforspecificcases.Pleaseconsultamedicalprofessionalformedicaladvice. Apple,theApplelogo,andiPhonearetrademarksofAppleInc.AppStoreisaservicemarkofAppleInc.Android,GooglePlayandtheGooglePlaylogoaretrademarksofGoogleInc.