ADVANCING the art and science of NPWT negative pressure wound therapy.

Transcription

1 ADVANCING the art and science of NPWT negative pressure wound therapy

2 NPWT THE SCIENCE OF NEGATIVE PRESSURE WOUND THERAPY Basic Mechanisms of Negative Pressure Wound Therapy Three leading mechanisms of action are thought to contribute to the wound healing benefits of negative pressure wound therapy (NPWT): Vacuum Assisted Drainage: Excess exudate contains microorganisms, debris, proteolytic enzymes and other components that prolong inflammation, cause edema and delay healing. Removing this excess exudate through vacuum assisted drainage aids in microbial control, while maintaining a moist environment for important for healing. Reduction of Interstitial Fluid: Removal of interstitial fluid reduces edema and decompresses tissue, allowing for improved capillary perfusion and angiogenesis. This action increases the oxygen and nutrient supply, as well as access for white blood cells important to the healing process. 1 Mechanical Effects on Blood Flow, Cell Growth and Cell Proliferation: NPWT produces mechanical stress and creates a pressure gradient across tissues. In addition to increasing blood flow, this places physical strain on cells that stimulates interaction with soluble growth factors in the extracellular matrix. The effect is often referred to as cell stretch. Cell stretch encourages cell proliferation and maturation, resulting in improved vessel growth, collagen disposition, and granulation tissue formation. Intermittent and Variable Therapy Recommended for Best Results A strong and growing number of studies suggest intermittent and variable NPWT is more beneficial to the patient than continuous NPWT. Using intermittent NPWT may both increase blood flow to the wound site and increase new granulation tissue proliferation by 40% over the use of continuous NPWT. 1 Some researchers theorize cycling the negative pressure increases the of microvascular perfusion to wounds with a hypoperfused halo at the wound edge. The halo decreases as blood flow disperses into the surrounding tissue, minimizing possible ischemic effects. 1 Low Levels of Continuous Pressure Recommended Recent research indicates low levels of pressure may be beneficial to minimize ischemia in the hypofused zone surrounding the wound edge, especially in soft tissue. Research done at the Lund University Medical Center recommends using -80mmHg for soft tissue and slightly higher for muscle tissue. 2 2

3 VPT VARIABLE PRESSURE THERAPY Research confirms intermittent negative pressure increases blood to the wound site more effectively than continuous negative pressure and proliferation of new granulation tissue is significantly higher. 2,3 Until now, pumps available on the market were unable to provide practical, comfortable variable pressure therapy. Prospera VPT technology is engineered to deliver comfortable, massaging variable pressure therapy for best results and patient comfort. Customizable time and pressure settings. Calibrated to increase and decrease in comfortable 5mmHg increments between -40mmHg and -80mmHg, providing a gentle massaging effect. Virtually eliminates painful high and low pressure spikes. 3,4,5 Always maintains negative pressure, never dropping to 0mmHg. Negative Pressure in mmhg Variable Pressure Therapy (VPT )* Prospera Recommended VPT Pressure Range Time in minutes Intermittent pressure levels of other brands = -125 to 0 mmhg (spike) VPT pressure ranges of Prospera = -80 to -40 mmhg (gradual) 3

4 NPWT Why DeRoyal Pro Series? ENGINEERED Next Generation NPWT Since 2006, DeRoyal has been providing NPWT accessories, kits and devices to assist in healing hard to heal wounds. SCIENTIFIC/CLINICAL Benefits of VPT VPT is proven to be the most effective form of NPWT providing a simple, comfortable and efficient wound treatment system. 5 INCREASED Traceability State of the art GPS tracking systems and anytime/anywhere dashboard access to unit location. REDUCED Cost The DeRoyal NPWT system and protocols ensure optimal outcomes at reduced cost levels. INCREASE Continuity of Care Provide continuity of care with DeRoyal s breadth and depth of product line offerings. The Advanced NPWT Solution TM 4

5 PRO-II Portable, Lightweight, Trackable PRO-III Full Featured, Hospital Ready, Lots of Options Lightweight and discreet, the PRO-II is portable and comfortable so your ambulatory and homecare patients can get on with their lives. The PRO-III delivers all the benefits of NPWT with advanced new features developed to further simplify use. Features Contoured design for patient comfort Virtually silent operation Discreet, disposable canister Over 24-hour battery run time Carrying case that can be worn on the waist or over the shoulder Lower pressure settings enhance comfort during use Variable Pressure Therapies (VPT ) provides intermittent pressure in the form of a gentle massage effect eliminating painful high to low spikes characteristic of traditional intermittent pressure Benefits Flexible, easy to use settings with CPT (Continuous) or VPT (Variable) Pressure Therapies Contoured design makes pump easy to wear at the waist or over the shoulder Reduces pain and discomfort with wear time and dressing changes 3,4 Reduces the need for pain medication prior to dressing changes Features Larger display screen Color coded display screens to signal pump idle (yellow), pump running (green), and error message (red) Lighter weight The proprietery Prospera Dual Filtration System (DFS ) is an industry first featuring internal and external bacteria filters to increase patient safety by reducing cross contamination risk Patient mode which will provide ability to adjust alarm sensitivities and monitor patient compliance Benefits Flexible, easy to use settings with CPT (Continuous) or VPT (Variable) Pressure Therapies Totally customizable Simple, comfortable dressing protocol Clinical support Virtually silent operation Cost-effective outcomes INDICATIONS FOR USE: The PRO Series Negative Pressure Wound Therapy Systems are indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing. For a complete listing of Features, Benefits, Indications and Contraindications, please visit deroyal.com/npwt * IMPORTANT: Consult instructions for use for complete directions, warnings, and precautions. 5

6 NPWT MOBILE Tracking your mobile medical equipment has never been easier. Designed as a turnkey solution: Continuum Mobile is a hardware, software, and data solution that allows you to know where your mobile medical equipment is at all times, saving you time, money, and headaches. Choose from a variety of smart sensors and monitor critical asset data from your very own enterprise grade web portal. Continuum Mobile will even send notifications via text or when alerts are triggered, such as if an enabled device has left the property or if it s traveling more than 5 mph. Weight: Less than 5 oz. Power: 6 month rechargeable battery at 4 pings/day Charging: Mini USB (Included) Communication: CDMA-1xRTT; GSM 2G and 3G Conformity: FCC part 15; Network Certified Positioning: Standalone and Assisted GPS; Accurate to 3 meters Alerts: Inside or outside geo-fence Custom Housing: Available Options: Temperature, runtime, geo-fencing GPS Production: Made in the USA PRO-II with GPS attached Enterprise-grade Web Portal Track your assets from anywhere in the world where an internet connection is available using our secure enterprise grade web portal! Simply login with your username and password using your desktop, smart phone, or tablet. Our user friendly web portal displays detailed location history, alarm history, and critical data such as temperature, motion, run time, battery life, geofencing alerts, travel speed, and many other metrics. 6

7 ADVANCING the art and science of NPWT with the largest selection of kits and accessories Foam Dressings DeRoyal offers all the necessary foam dressings needed for NPWT today. Our black foam dressings are designed to absorb moderate to heavy exudate associated with deep wounds and are customizable to any wound size. Our thin foam dressings are designed to protect wounds with less exudate. White foam dressings are indicated for wounds that may have exposed bone, tendon, vessels, tunneling, or undermining. We also offer silver dressings, such as Dermanet Ag contact layer that serve as anti-microbial barrier against a broad spectrum of wound pathogens. 6 AMD Gauze Dressings AMD gauze provides protection against a wide-range of bacteria. 7 It is easy to apply and remove in one piece and the white, absorbent nature of the gauze makes it easy to monitor exudate at the wound site. NPWT KITS SMALL FOAM KIT WITH TS+ NP-0005 (10/Cs) MEDIUM FOAM KIT WITH TS+ NP-0006 (10/Cs) 1 - Transeal Plus (TS+) 8" x 12" 1 - Small Foam Square (10 cm x 8 cm x 3 cm) 2 - Transeal Plus (TS+) 8" x 12" 1 - Medium Foam Square (20 cm x 12.5 cm x 3 cm) 7 7

8 NPWT NPWT KITS LARGE FOAM KIT WITH TS+ NP-0007 (10/Cs) SMALL FOAM KIT WITH TRT NP-0500 (10/Cs) 3 - Transeal Plus (TS+) 8" x 12" 1 - Large Foam Square (25 cm x 15 cm x 3 cm) 1 - Triple Release Transeal (TRT) 8 x Small Foam Square (10 cm x 8 cm x 3 cm) X-LARGE FOAM KIT WITH TS+ NP-0008 (5/Cs) MEDIUM FOAM KIT WITH TRT NP-0501 (10/Cs) 4 - Transeal Plus (TS+) 8 x X-Large Foam Square (45 cm x 30 cm x 3 cm) 2 - Triple Release Transeal (TRT) 8" x 12" 1 - Medium Foam Square (20 cm x 12.5 cm x 3 cm) 8

9 LARGE FOAM KIT WITH TRT NP-0502 (10/Cs) MEDIUM FOAM KIT WITH TRT & DERMANET AG+ NP-0506 (10/Cs) 3 - Triple Release Transeal (TRT) 8 x Large Foam Square (25 cm x 15 cm x 3 cm) 1 - Dermanet Ag+ 8 x Triple Release Transeal (TRT) 8 x Medium Foam Square (20 cm x 12.5 cm x 3 cm) SMALL FOAM KIT WITH TRT & DERMANET AG+ NP-0505 (10/Cs) LARGE FOAM KIT WITH TRT & DERMANET AG+ NP-0507 (10/Cs) 1 - Dermanet Ag+ 4 x Triple Release Transeal (TRT) 6 x Small Foam Square (10 cm x 8 cm x 3 cm) 1 - Dermanet Ag+ 8 x Triple Release Transeal (TRT) 8 x Large Foam Square (25 cm x 15 cm x 3 cm) 9 9

10 NPWT SMALL THIN FOAM KIT WITH TS+ NP-0515 (10/Cs) LARGE THIN FOAM KIT WITH TS+ NP-0517 (10/Cs) 1 - Transeal Plus (TS+) 8 x Small Thin Foam Square (10 cm x 8 cm x 1.5 cm) 3 - Transeal Plus (TS+) 8 x Large Thin Foam Square (25 cm x 15 cm x 1.5 cm) MEDIUM THIN FOAM KIT WITH TS+ NP-0516 (10/Cs) MEDIUM WHITE FOAM KIT WITH TRT NP-0103 (10/Cs) 2 - Transeal Plus (TS+) 8 x Medium Thin Foam Square (20 cm x 12.5 cm x 1.5 cm) 1 - Triple Release Transeal (TRT) 8 x White Foam Squares (3.75 x 3.75 ) 2 - Saline 30 ml 10

11 LARGE WHITE FOAM KIT WITH TRT NP-0104 (10/Cs) MEDIUM GAUZE KIT WITH TRT NP-0014 (10/Cs) 2 - Triple Release Transeal (TRT) 8 x White Foam Squares (6 x 6 ) 2 - Saline 30 ml 2 - Triple Release Transeal (TRT) 8 x AMD Gauze Sponge 2/Pk 1 - Saline 30 ml SMALL GAUZE KIT WITH TRT NP-0013 (10/Cs) LARGE GAUZE KIT WITH TRT NP-0015 (10/Cs) 1 - Triple Release Transeal (TRT) 8 x AMD Gauze Sponge 2/PK 1 - Saline 30 ml 3 - Triple Release Transeal (TRT) 8 x Sponge Kerlix AMD Roll 2 - Saline 30 ml 11 11

12 NPWT NPWT ACCESSORIES PRO-II Canister (250cc) NP-1004 (30/Cs) NP (10/Cs) PRO-III Canister w/filter (800cc) NP-1000 (10/Cs) PRO-III Canister Holder (Ring) NP-1001 (10/Cs) PRO-III Patient Tube & Filter NP-1002 (10/Cs) PRO-III Canister & Solidifier NP-1005 (10/Cs) PRO-III Canister, Patient Tube, Solidifier & Filter NP-1006 (10/Cs) PRO-III Canister Patient Tubing NP-1007 (5/Cs) 12 PRO-III Canister, Patient Tube, Solidifier & Filter NP-1008 (10/Cs) PRO-III Canister, Patient Tube & Filter (Does not include Solidifier) NP-1009 (10/Cs)

13 Black Foam (10/Cs) STANDARD THIN NP-200 sm NP-204 sm NP-201 md NP-205 md NP-202 lg NP-206 lg TopDraw Dome Connector NP-180 (10/Cs) Drain Conversion NP-0019 channel drain (10/Cs) NP-0024 round drain (10/Cs) (10/Cs) NP-0025 flat drain Bed Rack NP-170 Pro-II (1/Cs) NP-140 Pro-III (1/Cs) IV-Pole Holder NP-150 (1/Cs) Universal Y-Connector NP (10/Cs) NP-120 (100/Cs) Power Cord NP-2002 (1/Cs) PRO-II Carrier Bag NP-2001 (1/Cs) PRO-III Carrier Bag NP-3001 (1/Cs) 13 13

14 NPWT NPWT KITS & ACCESSORIES OFFERING DOME KITS Black Foam ACCESSORIES NP-0000 Gauze Training Kit 25/Cs NP-0005 Small Foam Kit w/sd 10/Cs NP-1111 Foam Training Kit 25/Cs NP-0006 Medium Foam Kit w/sd 10/Cs NP-2001 PRO-II Carrier Bag 1/Cs NP-0007 Large Foam Kit w/sd 10/Cs NP-3001 PRO-III Carrier Bag 1/Cs NP-0008 X-Large Foam Kit w/sd 5/Cs NP-2002 Power Cord 1/Cs NP-0500 Small Foam Kit w/sd/tr 10/Cs NP-120 Y-Connector 100/Cs NP-0501 Medium Foam Kit w/sd/tr 10/Cs NP Y-Connector 10/Cs NP-0502 Large Foam Kit w/sd/tr 10/Cs NP-140 PRO-III Bed Rack 1/Cs STANDARD KITS NP-0505 Small Foam Kit w/sd/dag 10/Cs NP-0506 Medium Foam Kit w/sd/dag 10/Cs NP-0507 Large Foam Kit w/sd/dag 10/Cs NP-0515 Small Thin Foam Kit w/sd 10/Cs ACCESSORIES NP-170 PRO-II Bed Rack 1/Cs NP-150 IV-Pole Holder 1/Cs NP-180 Dome Connector (Top Draw) 10/Cs NP-200 Small Black Foam 10/Cs NP-0516 Medium Thin Foam Kit w/sd 10/Cs NP-201 Medium Black Foam 10/Cs NP-0517 Large Thin Foam Kit w/sd 10/Cs NP-202 Large Black Foam 10/Cs White Foam NP-0101 Medium White Foam 10/Cs NP-0103 Medium White Foam Kit w/sd 10/Cs NP-0102 Large White Foam 10/Cs NP-0104 Large White Foam Kit w/sd 10/Cs NP-300 Bridge Kit 5/Cs Gauze NP-350 Incision Kit 5/Cs NP-0013 Small Gauze Kit w/sd 10/Cs B 6 x 8 Transeal TR 100/Cs NP-0014 Medium Gauze Kit w/sd 10/Cs B 8 x 12 Transeal TR 100/Cs NP-0015 Large Gauze Kit w/sd 10/Cs THERAPY UNITS NP-2000 PRO-II 1/Cs UNITS NP-2000GPS PRO-II w/mobile Continuum 1/Cs NP-3000 PRO-III 1/Cs NP-3000GPS PRO-III w/mobile Continuum 1/Cs CANISTERS CANISTERS SKU UNIT Canister Tubing & Filter Solidifier 6-in-1 Tubing Count NP-1000 PRO-III YES YES YES NO 10 NP-1001 PRO-III NO NO NO NO 10 NP-1002 PRO-III NO YES NO NO 10 NP-1004 PRO-II YES N/A YES N/A 30 NP PRO-II YES N/A YES N/A 10 NP-1005 PRO-III YES NO YES NO 10 NP-1006 PRO-III YES YES YES YES 10 NP-1007 PRO-III NO NO NO NO 5 NP-1008 PRO-III YES NO NO YES 10 NP-1009* PRO-III YES YES NO YES 10 * Build to Order NP-1006 shown here 14

15 DOME KIT APPLICATION Step-by-Step Process to Applying TopDraw Dome Kits IMPORTANT: Consult instructions for use for complete directions, warnings, and precautions. STEP 1 Cleanse wound gently and carefully with saline until the wound is free of debris and dead tissue. Gently blot dry the wound edges, periwound margin, and all skin to be covered by transparent dressing. (Prepare wound according to facility protocol) STEP 2 If desired, place a primary, non-adherent dressing such as Transeal on the wound bed. Do not overlap on to intact skin. a. For foam dressing application, measure the wound and cut the foam to the appropriate size and shape. Gently place the foam dressing into the wound cavity. Fill the entire wound cavity but do not overlap on the intact skin. Do not cut the foam over the wound, as small fragments may fall into the wound bed. Do not force or push the foam dressing into the wound, as this may cause further injury to the wound. b. For gauze dressing application, open the gauze and moisten with saline. Gently place the gauze in the wound bed. Fill the entire wound cavity but do not overlap on the intact skin. Do not force, push or over pack the gauze into the wound, as this may cause further injury to the wound. STEP 3 Size and cut the Transeal transparent dressing to cover the primary dressing, making sure the primary dressing is completely covered and the Transeal overlaps on the intact skin by at least one inch on all edges of the wound. Proper Transeal application is the key to fewer alarms and less loss of seal issues. STEP 4 Gently press the top of the Transeal to ensure adhesive adheres to the skin. Remove the carrier layer of the Transeal

16 NPWT STEP 5 Gently lift the Transeal with your thumb and forefinger. Cut a 2 to 2.5 cm hole in the Transeal over the center of the wound using either scissors or scalpel. STEP 6 Do not cut a slit, as a slit could collapse and block the suction when pressure is applied. Hold the tab and pull the paper to release the liner from the dome pad. STEP 7 Place the center of the dome pad directly over the cut hole. STEP 8 Ensure the seal is completely adhered to the skin. IMPORTANT: Consult instructions for use for complete directions, warnings, and precautions. 16

17 STEP 9 Peel the clear backing liner off the connector. Peel off the tabs, and pat around the dome pad to recheck the seal is completely adhered to the skin. STEP 10 Connect the dome pad tubing to the end of the connector tube attached to the canister. Every dome connector will have an adapter included. STEP 11 Turn on the NPWT system, making sure that the pressure is set at the proper mmhg per doctor s order. STEP 12 Once the NPWT is turned on, the primary dressing, dome pad, and Transeal will start to compress. A compressed look means the Transeal is properly adhered to the skin and negative pressure is reaching the wound. IMPORTANT: Consult instructions for use for complete directions, warnings, and precautions

18 NPWT TECHNICAL DATA Air-flow rate of pump 8 liters/min Negative pressure Max. 200mmHg (Conversion factor: 1kPa ~ 7.5mmHg) Collection canister (PRO-III) Disposable canister systems Suction tubing (PRO-III) Various drainage systems, depending on supplier and specific applications. Type and kind of use are determined by the medical staff. Nominal voltage of power supply adapter V primary, 12VDC secondary Power requirements V, 50/60Hz, 45W Maximum load current 1.25 A Mains frequency of power supply adapter 50/60Hz Nominal voltage of electronic circuit board 12V Power consumption 15W (charging operation)/10w (charging only) Current consumption 1.25A Rechargeable battery 7.4V, 4.4Ah lithium-ion battery Charging time of empty battery half empty battery 6 7 hours hours PRO-II dimensions (W x H x D) 8.4" x 6.5" x 3.5" PRO-III dimensions (W x H x D) 11.4 x (canister) x 5.1 PRO-II weight (basic unit) 1.3kg (2.65 lbs.), with canister PRO-III weight (basic unit) 1.8kg (3.97 lbs.) Operating time AC operation: continuous operation DC operation: approx hours, depending on use Degree of protection according to IEC Type BF Risk class according to 93/42/EEC, IX IIa Sound emission 35dB (A) Protection class according to IEC II REIMBURSEMENT The PRO Series of pumps are reimbursable under most third party payer plans. Below are the Medicare HCPCS codes for the Negative Pressure Wound Therapy System: Therapy Units (PRO-II and PRO-III) Code: E2402 Negative pressure wound therapy electrical pump, stationary or portable DRESSING CHANGE KIT Code: A6550 Wound care set, for negative pressure wound therapy electrical pump, includes all supplies and accessories CANISTER Code: A7000 Canister, disposable, used with suction pump, each The HCPCS information is for information purposes only. It represents no statement, promise, or guarantee by DeRoyal concerning level of reimbursement, payment, or charge. It does not and is not intended to increase or maximize reimbursement, nor does it promise or guarantee that the codes listed will be appropriate or that reimbursement will be made. Please consult your payor organization to obtain the most current information about your local Medicare Part B coverage and reimbursement policies. 18

19 Thank you for your interest in DeRoyal s Negative Pressure Wound Therapy products. We share the same passion for patient comfort, wound healing, and ease-of-use as you do. We are confident that we can provide all the necessary tools for you to administer the best possible care for your patients. For more information, please contact your local DeRoyal Wound Care representative. My Kaywa QR-Code Scan QR Code to view NPWT on APPLICATION VIDEOS For further instructions on how to apply DeRoyal s dome connector, and other specialty dressings, please visit www. deroyal.com or subscribe to DeRoyal s YouTube channel. Below is a complete list of helpful tutorials: Scan QR Code to view videos - Application of Dressing with Dome Connector - Application of Foam Dressing with Drain - Application of Gauze Dressing with Dome Connector - Continuous Pressure Therapy Mode - Customizing Sensitivity Levels - Operating the PRO Series Therapy Units - Pro-II Components and Set Up - Pro-III Components and Set Up - Skin Prep - Specialty Dressing Application - Bridge Dressing - Specialty Dressing Application - Mushroom Dressing - Specialty Dressing Appliction - Offsetting Technique - Understanding Alarms - Variable Pressure Therapy Mode Download the Kaywa QR Code Reader (App Store &Android Market) and scan your code! References 1. Morykwas MJ, Argenta LC, Shelton-Brown EI, McGuirt W. Vacuum-Assisted Closure: A new method for wound control and treatment: Animal studies and basic foundation. Annals of Plastic Surgery 1997;38: Borquist, O., Ingemansson, R., Malmsjo, M., The Influence of Low and High Pressure Levels during Negative Pressure Wound Therapy on Wound Contraction and Fluid Evacuation. Plastic and Reconstructive Surgery, February 2011; 127:2: Eberlein T, Fendler H, Ahearn C. Using a new technique for negative pressure wound therapy (NPWT) for the management of chronic, non-healing wounds. SAWC 2008, San Diego 4. Eberlein T, Fendler H. Using a new technique of negative pressure wound therapy (NPWT), Variable Pressure Therapy (VPT) for the management of chronic, non-healing wounds. JWOCN May/June 2009;36(35):S23 5. Malmsjö, M., Gustafsson, L., Lindstedt, S., Gesslein, B., & Ingemansson, R. (2012). The Effects of Variable, Intermittent, and Continuous Negative Pressure Wound Therapy, Using Foam or Gauze, on Wound Contraction, Granulation Tissue Formation, and Ingrowth Into the Wound Filler. Eplasty, 12, e5. 6. An in-vitro laboratory study using the Kirby-Bauer Susceptibility Test to determine antimicrobial properties by measuring the zone of inhibition. Data on file with DeRoyal Industries. 7. Davydov YA, Malafeeva AP, Smirnov AP. Vacuum therapy in the treatment of purulent lactation mastitis. Vestnik Khirurgii. 1986;9: Trademark Attributions DeRoyal, the DeRoyal logo, Improving Care. Improving Business. Continuum, Dermanet, Pro-II, Pro-III, Prospera, TopDraw, Transeal, and VPT are registered trademarks of DeRoyal Industries, Inc. Advanced NPWT Solutions is a trademark of DeRoyal Industries, Inc

20 DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN USA 800.DEROYAL or Customer Service: , DeRoyal Industries, Inc. All Rights Reserved Reprint #: Rev. 04/16