RENASYS TOUCH NPWT Clinical Guidelines Sept 2016

Table of contents Introduction 5 Wound bed preparation 7 Optimization of NPWT  8 Wound assessment  9

RENASYS™ introduction 11 Description  12 Important Information – monitoring NPWT 12 Indications for use  12 Contraindications  13 Warnings  13 Precautions  13 Precautions specific to RENASYS TOUCH 15

General therapy considerations 17 Choosing a wound filler and interface  18 Wound characteristics   18 Considerations for device   20 RENASYS TOUCH portfolio – pumps and canisters  21 Pump/canister optimization   22 Dressing changes  23 NPWT pressure settings  23 Delivering the right pressure level  24 Continuous versus Intermittent therapy 24 RENASYS Soft Port – considerations for use  25 Physician orders  25

RENASYS Dressing selection and application

27

RENASYS-G Gauze Dressing with Soft Port application technique  RENASYS-F Foam Dressing with Soft Port application technique  Optimization of therapy/enhancing dressing wear time 

28 33 39

RENASYS™ advanced and complex dressing applications 41 Advanced and complex dressing techniques  42 Undermining and/or tunneling  43 Combination therapy  44 Skin grafts 46 RENASYS Adhesive Gel Patch  47

RENASYS AB Abdominal Dressing Kit with Soft Port 51 Description and Indications for Use   52 Dressing application technique  57

RENASYS appendix 61 RENASYS TOUCH troubleshooting  62 RENASYS FAQ 71 RENASYS ordering information 73

References 76

Introduction

Introduction - 5

Smith & Nephew has an extensive portfolio of wound care products and therapies that cover all major aspects of managing a wide range of wound types. It is a well-established principle that wounds are managed across a continuum of healing and require different therapies at each step in the continuum. Smith & Nephew offers negative pressure wound therapy (NPWT) as part of a complete range of wound care products to use along a patient’s journey towards healing. The key to deciding which product to use at each stage of the continuum is to identify the barriers to healing along with a treatment goal to combat those issues.1,2 NPWT is widely adopted as a standard treatment for patients with both acute and chronic wounds.3 A variety of formats are now available, and, as the wound progresses along the continuum, a switch from one format to another may be the most appropriate course. NPWT has been shown to be cost effective when used appropriately.4,5 Knowledge of when NPWT is most appropriate and when alternative therapies may be more appropriate is vitally important to maintain the efficient use of resources while not negatively affecting wound outcomes.3,6,7 Negative pressure wound therapy involves the application of controlled levels of sub-atmospheric (negative) pressure to a wound. The systems described in these guidelines consist of a suction pump to generate negative pressure and a variety of wound dressing kits to deliver the therapy to the wound site. The benefits of NPWT in progression towards wound healing go well beyond drainage management. Studies have shown that NPWT improves granulation tissue formation, may decrease bacterial burden, protects from the outside environment, promotes moisture balance within the wound bed, and may decrease the frequency of dressing changes.3 The following Clinical Guidelines should be used as a reference for treating wounds with RENASYS™ NPWT products. The Guidelines do not constitute and are not a substitute for medical advice or medical judgement. The Guidelines do not guarantee positive outcomes, wound healing or proper function of the RENASYS NPWT Device. As with any medical device, consult the physician/clinician concerning the patient’s individual condition and prescribed treatment. Always consult and follow all applicable user’s manuals, product inserts, instructions for use, safety information and reference guides for product use, operation and application.

6 - Introduction

Wound bed preparation Wound bed preparation has been defined as the process of removing the barriers to healing. Removal of these barriers is thought to allow the wound repair process to progress.1,2 The Tissue, Infection, Moisture and Edge (epithelial margin) “TIME” scheme is a useful way of identifying and removing barriers to healing. Wound bed preparation represents a combination of both scientific knowledge and practical skill; its application can help correct abnormalities in acute and chronic wounds and stimulate or progress the healing process.1 To optimize the use of negative pressure wound therapy, it is essential that clinicians ensure wound bed preparation is achieved prior to, during and after therapy.7

TIME principles of wound bed preparation

T Barrier

Intervention

Outcome

issue nonviable or deficient

Defective matrix and cell debris

Debridement

Restore wound base and ECM proteins

I

nfection or inflammation

High bacterial counts or prolonged inflammation

Antimicrobials

Low bacterial counts and controlled inflammation

M

oisture imbalance

Desiccation or excess fluid

Dressings Compression Restore cell migration, maceration avoided

E

dge of wound non-advancing or undermined

Non-migrating keratinocytes Non-responsive wound cells Biological agents Adjunct therapies Debridement Stimulate keratinocyte migration

Introduction - 7

Optimization of NPWT The effective use of NPWT relies on thorough assessment of the patient, the wound, and development of a plan for how the wound might be closed. When to debride and when to start and stop NPWT are keys to an effective treatment plan.8,9

Debride wound Effective debridement may: • Reveal extent of tissue damage • Reduce biochemical imbalance, senescent cells10 • Reduce bacterial burden10 • Reduce odor • Optimize healing potential10

Prepare the wound environment

Consequences of ineffective debridement are: • Potential for delayed healing • Potential for infection • Physical barrier preventing accurate assessment • Reduced patient Quality of Life (QoL) • Psychological aspects

Know when to stop or change treatment

Use NPWT

Optimal healing/ cost-effective wound care

Optimize healing – mechanisms of action3 • Remove exudate • Assist in wound contraction • Stimulate granulation tissue • Protect from outside contaminants • Increase vascular perfusion

Foam

• May reduce wound bioburden • Remodel connective tissue matrix • Encourage maturation of epithelial cells • Maintain a moist wound environment

Gauze

Know when to stop or change treatment • Established goal of therapy has been met3,8 • No improvement or reduction in wound volume has been documented consecutively for 2 weeks8 • Individual patient characteristics and wound considerations may vary clinical decisions in regards to whether to continue or discontinue NPWT8

8 - Introduction

General therapy considerations

Wound assessment NPWT treatment depends heavily upon the quality of the clinical wound assessment. The wound should have a detailed assessment at the initiation of the NPWT treatment regime and with every dressing change thereafter. The following areas should be addressed with every wound assessment: Wound size: length, width, depth • NPWT has the ability to assist with removal of interstitial fluid and sloughy necrosis.11,12 With the removal of the space filling materials, the volume of the wound may increase slightly. This will likely happen within the first few dressing changes, especially if the wound is in the inflammatory phase of wound healing. Granulation tissue: amount and description • Healthy granulation tissue should be beefy red and not bleed easily. No trauma should occur to the granulation tissue with dressing removal. A non-adherent dressing or a contact layer may be used to reduce pain or where the risk of tissue ingrowth is present.3 Epithelialization: amount and description • Epithelialization is thin and often noted to be shiny or silver in appearance and may be hard to see. The new cells are very fragile. If undermining is present, it is important to fill the undermined areas with gauze or foam to prevent the edges from rolling under. Necrotic tissue: type and amount • The use of NPWT in wounds with necrotic tissue with eschar present is contraindicated. • Necrotic tissue is devitalized tissue and often appears black or brown, hard and dry. Soft or boggy necrotic tissue should be assessed for infection. • NPWT, along with the autolytic environment established by the Transparent Film, may result in a decrease in necrotic slough.11,13 Slough • Slough is necrotic or devitalized tissue that is yellow in appearance and can be dry or moist. Exudate: type, amount and consistency • Assess wound exudate for type, amount, color and consistency. Evaluate the wound exudate for consistent characteristics with the wound type and the anticipated exudate. Significant changes in exudate warrant a reassessment of the wound. Odor: present/absent, description • It is important to note that body fluids that have been contained in a sealed system for an extended period of time may likely have an unpleasant odor. This odor is not a direct indication of wound infection. Remove dressing and cleanse wound per facility protocol. If odor persists, assess for wound infection, and if required, treat and increase frequency of dressing until odor is under control. The use of an antimicrobial wound contact layer may be used to reduce bacterial burden.14 If odor persists, contact your Smith & Nephew representative for possible pump replacement or service. Pain: use facility approved tool for rating pain • There should not be pain with the RENASYS™-G Gauze Dressing Kit. If the patient experiences pain, decrease the amount of pressure. The pressure range is 40-120mmHg which should allow for pressure adjustments. • When using the RENASYS-F Foam Dressing Kit, tissue adherence may be reduced by use of a non-adherent wound contact layer, decreasing the pressure, and/or increasing the frequency of the dressing changes to decrease tissue ingrowth.3 • Consider utilizing RENASYS-G Gauze Dressing Kit. See choosing a wound filler/interface.

Introduction - 9

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RENASYS™ introduction

RENASYS introduction - 11

RENASYS™ Negative Pressure Wound Therapy RENASYS TOUCH RENASYS-F Foam Dressing Kit with Soft Port RENASYS-G Gauze Dressing Kit with Soft Port NOTE: Full device operation is found in the Clinician User Manual for the RENASYS TOUCH Device

Description RENASYS NPWT Devices are designed to provide NPWT to a closed environment over a wound, in order to evacuate exudate from the wound site to a disposable canister, which may promote wound healing via removal of fluids, including irrigation and body fluids, wound exudate and infectious materials.

Important information – monitoring NPWT Carefully and frequently monitor the patient, device, and dressing frequently to determine if there are any signs of bleeding, exudate accumulation (pooling), infection, maceration, or loss of negative pressure wound therapy. The frequency should be determined by the clinician based on individual characteristics of the patient and wound. Warning: Carefully monitor patients for signs of bleeding, which may lead to interruption in therapy and hemodynamic instability. If such symptoms are observed, immediately discontinue therapy, take appropriate measures to control bleeding, and contact treating clinician NPWT may be impacted by various conditions related to system configuration, set-up and individual characteristics of the patient and wound (eg exudate characteristics, patient anatomy). Alignment of the port to the opening in the drape, use of a bridging technique and choice of dressing configuration based on wound characteristics may impact NPWT vacuum delivery over the course of therapy. Exudate volume, viscosity and consistency may influence fluid removal or occlusion formation. A full canister, incorrect canister orientation and device/tubing height relative to the wound can contribute to loss of NPWT and the accumulation of exudate within the wound, which could lead to maceration, infection, or unrecognized bleeding. Monitor the wound for infection and ensure that all wound filler is removed at each dressing change to reduce the risk of infection. Skin grafts should be closely monitored to ensure NPWT is being delivered. Review indications, contraindications, warnings and precautions before use.

Indications for use The RENASYS System is indicated for patients who would benefit from a suction device (negative pressure) as it may promote wound healing via removal of fluids, body fluids, wound exudate and infectious materials. • • • • • • •

Appropriate wound types include: Chronic Acute Traumatic Sub-acute and dehisced wounds Ulcers (such as pressure or diabetic) Flaps and grafts Partial thickness burns

12 - RENASYS introduction

Contraindications The use of the RENASYS™ System is contraindicated in the presence of: • • • • • •

Necrotic tissue with eschar Untreated osteomyelitis Malignancy in wound (with exception of palliative care to enhance quality of life) Exposed arteries, veins, organs or nerves Non-enteric and unexplored fistulas Anastomotic sites

Warnings NOTE: Full device operation is found in the User Manual for the RENASYS TOUCH Device 1. Carefully monitor patients for signs of bleeding, which may lead to interruption in therapy and hemodynamic instability. If such symptoms are observed, immediately discontinue therapy, take appropriate measures to control bleeding, and contact treating clinician. 2. Patients suffering from difficult hemostasis or who are receiving anticoagulant therapy have an increased

risk of bleeding. During therapy, avoid using hemostatic products that, if disrupted, may increase the risk of bleeding.

3. Do not use directly on exposed blood vessels or organs. Sharp edges such as bone fragments must be

covered or removed prior to initiating therapy, due to risk of puncturing organs or blood vessels drawn closer under the action of negative pressure.

4. NPWT has not been studied on pediatric patients. Patient size and weight should be considered when

prescribing the device.

5. Foam or gauze must not be tightly packed or forced into any wound area. Over-packing may interfere with

distribution of NPWT evenly across the wound. This may decrease the ability of the wound to properly contract and permit exudate to remain in wound. Do not place foam into blind or unexplored tunnels

6. In the event defibrillation is required, disconnect device from wound dressing prior to defibrillation. Remove

wound dressing only if its location will interfere with defibrillation.

7. Device is not MRI compatible. Do not bring device into MRI suite. Prior to entering MRI suite, disconnect

device from dressing. Dressing can remain intact on patient.

8. Device is unsuitable for use in areas where there is danger of explosion (eg, hyperbaric oxygen unit). 9. When operating, transporting or disposing of device and accessories, there is risk of infectious liquids

being aspirated or contamination of device assembly through incorrect use. Universal precautions should be observed whenever working with potentially contaminated components or equipment.

10. Device and canister kits are provided non-sterile and should not be placed within a sterile field.

Precautions NOTE: Full device operation is found in the User Manual for each RENASYS TOUCH Device. 1. More frequent device and wound dressing monitoring, should be taken for patients who are or may be:

• Suffering from infected blood vessels • Receiving anticoagulant therapy or platelet aggregation inhibitors, in addition to patients with intrinsic coagulation problems such as low platelet counts • Actively bleeding or have friable blood vessels or organs • Suffering from abnormal wound hemostasis • Untreated for malnutrition • Noncompliant or combative • Suffering from wounds in close proximity to blood vessels or friable fascia When monitoring patients for delivery of therapy, ensure wound dressing is free of air leaks, fully compressed and firm to the touch. 2. As a condition of use, device should only be used by qualified and authorized personnel. User must have

necessary knowledge of the specific medical application for which NPWT is being used.

RENASYS introduction - 13

3.

The dressing seal may be lost or pooling may occur, without alarm activation, when an occlusion forms on the wound side of the dressing. Viscous, purulent or serosanguineous drainage may contribute to occlusion of the dressing. Regular monitoring of device and dressing is required to ensure full delivery of therapy and exudate removal. Ensure the wound dressing is free of air leaks, fully compressed and firm to the touch whenever therapy is active.

4.

Underlying structures, such as bone, tendons, ligaments and nerves should be covered with natural tissue or a non-adherent dressing layer prior to applying the NPWT dressing to ensure protection and minimize the risk of damage from direct contact with the dressing.

5.

To minimize the risk of bradycardia, do not place NPWT in proximity to the vagus nerve.

6.

In the event a patient with spinal cord injury experiences autonomic dysreflexia, discontinue use of NPWT and immediately seek medical assistance.

7.

When treating enteric fistulas, do not place NPWT dressing in direct contact with exposed bowel. Cover the wound bed, including fistula opening, with non-adherent gauze or with one layer of saline moistened gauze. During the course of treatment patient’s fluid levels must be closely monitored.

8.

Avoid use of circumferential dressings except in cases of edema or heavily exuding extremities, where this technique may be necessary to maintain a seal. Consider using multiple drapes to minimize risk of decreased distal circulation. Regularly assess distal pulses, and discontinue therapy if changes in circulation are detected.

9.

As NPWT is not intended to directly treat infection, if there are any signs of systemic infection or advancing infection at wound area, contact treating clinician immediately.

10. If multiple pieces of foam or gauze are needed to fill the wound profile, count and record how many pieces

are present to ensure all pieces are removed at a dressing change to minimize the risk of retention and possible infection.

11.

NPWT should remain on for duration of treatment. The length of time a patient may be disconnected from device is a clinical decision based on individual characteristics of patient and wound. Factors to consider include location of wound, volume of drainage, integrity of dressing seal, assessment of bacterial burden and patient’s risk of infection.

12. Do not use a dressing kit with breached or damaged packaging. 13. Use of NPWT presents a risk of tissue ingrowth. Tissue ingrowth may be reduced by reducing therapy

pressure, using a wound contact layer or increasing the frequency of dressing changes.

14. NPWT should not be painful. If patient reports discomfort, consider reducing pressure setting and use of a

wound contact layer. Pressure setting is a clinical decision based on individual characteristics of patient and wound. Factors to consider include location of wound, volume of drainage and integrity of dressing seal.

15. Maintain regular monitoring of device and wound site during therapy to ensure therapeutic treatment and

patient comfort.

16. When bathing or showering patient must disconnect from device, protecting the end of the RENASYS™ Soft

Port tubing using a tethered cap. Ensure aeration disc located near Quick Click Connector is free of moisture before reactivation of therapy to ensure proper alarm functionality and prevent interruption in therapy.

17.

If any liquids penetrate device, discontinue use and return to your Smith & Nephew authorized provider for service.

18. CT scans and x-ray have the potential to interfere with some electronic medical devices. Where possible,

move device out of x-ray or scanner range.

19

Use caution if device is used in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

Additional precautions: 20. Electrical power can only be removed by disconnecting power cord or AC power adaptor. Take care in

positioning the device to allow access to cord receptacle.

21. If power cord or power source is damaged, wires are frayed or exposed, do not use power cord. Contact

your Smith & Nephew representative for a replacement cord or power source.

22. Canisters kits are single use devices. Do not reuse. 23. Do not apply NO-STING SKIN-PREP™ Wipes directly to open wounds. NO-STING SKIN-PREP is flammable.

Use in a well ventilated area. Avoid using around flames and sources of ignition. Keep out of reach of children. For external use only.

14 - RENASYS introduction

24. As with all adhesive products, apply and remove dressing carefully from sensitive or fragile skin to

avoid blistering and skin stripping, especially after frequent dressing changes. Use of skin sealant may assist with protection of periwound skin.

25. If patient must be disconnected, the end of the RENASYS™ Soft Port and canister tubing should be

protected using tethered caps to avoid leakage of fluid and cross contamination.

Precautions specific to RENASYS TOUCH Device 1. RENASYS TOUCH Pump is only to be used with Smith & Nephew authorized components. Use

of any other products has not been proven safe and effective with RENASYS TOUCH.

2. In the event of heavy or viscous drainage with sediment or when blood is present, regular

monitoring and more frequent dressing changes may be required to reduce the risk of interruption of therapy, maceration, infection, and ensure proper exudate removal.

3. For patients with high risk of bleeding, use 300mL canister. Ensure the 300mL canister viewing

window is checked frequently for signs of bleeding.

For detailed product information, including indications for use, contraindications, effects, precautions and warnings, please consult the product’s Instructions for Use (IFU) prior to use. For further information please contact us at 1-800-876-1261.

RENASYS introduction - 15

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RENASYS™ general therapy considerations

RENASYS general therapy considerations - 17

Choosing a wound filler and interface Smith & Nephew offers the clinician flexibility with a choice of dressing kits for use with NPWT. The following dressing kits are available: RENASYS™-F Foam with Soft Port, RENASYS-G Gauze with Soft Port and RENASYS AB Abdominal Dressing Kit with Soft Port. The factors to consider when choosing a dressing kit are based on the patient, the wound characteristics and clinical judgment of the healthcare professional (HCP). Clinical studies have demonstrated that the overall healing rates, defined as percent reduction in wound volume/surface area per week, are similar with both gauze and foam.3,15,16 This validates that the HCP can expect similar efficacy from either type of filler. The following guidelines have been developed based on feedback and insights from HCPs who have used all RENASYS Dressing Kit options.

Factors to consider include: • • • • • • •

Wound size and volume Contour of wound bed Appearance of wound bed/tissue type Amount and type of exudate Anatomical location of wound, eg, weight bearing area Patient comfort and preference Caregiver skills NOTE: It is important that a holistic assessment is made of the patient and wound characteristics and that a decision is not just made on only one factor alone. The above list is not exhaustive and local clinical judgment must always be used. Always consult the IFU and safety information

Wound characteristics Wound size and volume • Small to moderate size wounds with shallow depth: both foam and gauze may be used with similar ease of application • Moderate to large surface area wounds with shallow depth: gauze is generally considered easier to apply • Moderate to large surface area wounds with deep depth: foam may be considered easier to use WARNING: Do not tightly pack or force foam into any areas of the wound. Do not place foam into blind or unexplored tunnels. Precaution: The use of negative pressure presents a risk of tissue ingrowth into the foam. Tissue ingrowth may be reduced by reducing therapy pressure, using a wound contact layer or by increasing the frequency of dressing changes.

RENASYS general therapy considerations - 18

Wound contour • Wound bed contour10

Gauze wound filler easily maintains contact with an irregular surface. Foam wound filler may not intimately contact irregular shape spaces in wound bed. In this case, gauze and foam may be used in combination. See combination therapy page 44. The choice of wound filler will be influenced by the amount and consistency of wound exudate High

Low Wound exudate level Gauze Foam

Precautions specific to gauze 1.

Use of gauze as a filler in wounds that are in a weight bearing location or have moderate to heavy drainage may challenge the transfer of fluid and vacuum. Foam is recommended in these wounds. RENASYS™ Foam and Gauze Fillers may be combined within the same wound when tunneling or undermining is present.18 Gauze may be used in the areas of undermining or tunneling, with foam placed in the remainder of the wound cavity. In wounds with large amounts of exudate a wound interface (non-adherent layer) is generally not recommended.

• Ensure gauze is placed into the contours of the wound rather than tightly packed into the wound. This will aid fluid transference.

Patient comfort • Pain is a very subjective experience and will vary with each patient. Research has shown that patients report less pain with gauze.20,21 Lower level

Higher level

Pain/discomfort

Gauze

Foam

RENASYS general therapy considerations - 19

Considerations for device The RENASYS™ TOUCH pump can be used on a variety of wounds. RENASYS TOUCH has an intuitive touchscreen display which is easy to navigate and has adjustable volume, compression rates and therapy modes. The device is able to deliver therapy from -25 to -200mmHg and Intermittent therapy from 0 to -200mmHg with adjustable cycle times. RENASYS TOUCH is able to provide comprehensive data on the device and provides access to quick reference guides to provide assistance. Refer to specific quick reference guides, Instructions for Use (IFU) or specific product user manuals for additional instructions. Please see the appendix for product components and ordering.

The RENASYS TOUCH: • Small to large volume complex wounds • Awkward anatomy and difficult to seal locations • Multiple wounds bridged • High exudate levels • Large surface area wounds • Open abdominal wounds • RENASYS AB Abdominal Dressing Kit with Soft Port • 16 hour battery life

Overview of NPWT modes NPWT can be delivered to the wound bed using 3 modes of delivery; Continuous, Intermittent or Variable. • Continuous: Pressure is applied constantly • Intermittent: Pressure is repeatedly switched on and off alternating between 0 and set pressure • Variable: Pressure is varied between two levels (set pressure and low pressure) maintaining a negative pressure environment throughout the therapy. Continuous NPWT

(a)

Intermittent pressure therapy

0 Time

(b)

Variable pressure therapy -120

Negative pressure (mm Hg)

-120

Negative pressure (mm Hg)

Negative pressure (mm Hg)

-120

0 Time

-40 0

(c)

Time

RENASYS Touch RENASYS EZ

NOTE:(inc. ThePLUS RENASYS TOUCH is able to deliver Intermittent and Variable intermittent NPWT using tailored time and MAX) settings defined by the clinician. RENASYS GO

Experimental studies have shown improvements in the rate of granulation tissue formation, wound contraction and blood flow with Intermittent and Variable NPWT compared with continuous NPWT.23-26 Some reports suggest that Intermittent NPWT may be painful in susceptible patients.27 Patients being treated with Variable NPWT have been shown to report less pain24 compared with Intermittent pressure. The choice to use Continuous or Intermittent therapy should be based on clinical judgment and the therapy objective of the wound being treated.

INTERMITTENT therapy is not recommended for:

• Highly exudating wounds • Wounds with tunnels or undermining • Wounds in difficult areas where maintaining a seal is problematic • Patients who experience pain during intermittent therapy

RENASYS general therapy considerations - 20

RENASYS™ TOUCH portfolio – pumps and canisters Refer to specific Instructions for Use or specific product User Manuals for additional instructions. There may be certain unique indications, contraindications, precautions and warnings for the product.

RENASYS TOUCH Pump Power source and NA power cord Clinician User Manual Service Manual Single patient use carrying case and strap available • IV pole/bed rail clamp available • • • • •

• • • •

300mL Canister Sealed canister With or without solidifier Canister tubing Kickstand

800mL Canister • Sealed canister with solidifier • Canister tubing

CAUTIONS: 1.

Canister kits are single use non-sterile.

2. Always use the smallest canister volume possible. DO NOT use the 800mL canisters on patients

with high risk of bleeding.

3. Canisters should be changed at least once a week, whenever there is a change of patient or in

the event that the canister contents reach maximum volume indication. Do not wait for canister over-capacity alarm activation to change canister. See page 73 of appendix for product components and ordering

RENASYS general therapy considerations - 21