V.A.C. Therapy KCI Licensing, Inc. All rights reserved. DSL# (4/12)

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1 V.A.C. Therapy 101

2 2 Important Information Prior to use of any V.A.C. Therapy System, it is important for the provider to: Consult the treating physician Read and understand all Instructions for Use, including Safety Information, and Dressing Application Instructions KCI recommends that clinicians participate in device in-service and training prior to use. All trademarks designated herein are proprietary to KCI Licensing, its affiliates and licensors. Rx only.

3 3 Objectives Describe the contraindications, warnings, and precautions of V.A.C. Therapy to be aware of prior to use of the system. Identify the Indications and wound types for V.A.C. Therapy. Identify the four phases of wound healing. Identify components of the V.A.C. Therapy Systems. Identify the Mechanisms of Action of V.A.C. Therapy. Describe the steps of Basic V.A.C. Therapy dressing application. Identify the correct methods to resolve leak, blockage, low pressure, and low battery alerts and alarms on the V.A.C. Therapy System.

4 4 V.A.C. Therapy is indicated for patients with: Chronic Wounds Acute Wounds Traumatic Wounds Sub-acute Wounds Partial-thickness burns Dehisced wounds Ulcers such as: Diabetic Venous Insufficiency Pressure Flaps Grafts

5 5 V.A.C. Therapy Contraindications DO NOT place any V.A.C. Foam Dressings (V.A.C. GranuFoam, V.A.C. GranuFoam Silver, V.A.C. WhiteFoam, V.A.C. VeraFlo and V.A.C. VeraFlo Cleanse Dressings) in direct contact with exposed blood vessels, anastomotic sites, organs or nerves. DO NOT use V.A.C. Therapy: when there is malignancy in the wound with untreated osteomyelitis with non-enteric and unexplored fistulas with necrotic tissue with eschar present DO NOT use the V.A.C. GranuFoam Silver Dressing on a patient with a known sensitivity to silver

6 V.A.C. Therapy Warning Categories Bleeding 6 To decrease bleeding risks: Protect vessels and organs Infected vessels are at risk of complications and must be carefully noted and protected. Cover or eliminate sharp edges Ensure adequate wound hemostasis Increase patient monitoring when: Anticoagulants, platelet aggregation inhibitors, aspirin, etc. are prescribed Wounds are related to vascular surgical procedures Infection is present in the wound

7 7 Considerations for V.A.C. Therapy Patients at Increased Risk of Bleeding With or without using V.A.C. Therapy, certain wound care patients are at high risk of bleeding complications Place at-risk patient in a monitored setting as MD deems appropriate Are organs or vessels visible and/or exposed? Preferably cover with a thick layer of natural tissue When natural tissue is not available, multiple layers of a non-adherent material can be used Never place any V.A.C. Dressing foam directly on organs, vessels, nerves, tendons, or ligaments Are weak or friable vessels noted in or around the wound? Infection, trauma and radiation can weaken vessels, increasing rupture potential Vascular surgery repairs (i.e., vessels with sutures, anastomosis, graft, etc.) Vessel repairs increase risk for complications regardless of treatment modality Require close monitoring when wound close to large vessels (e.g., femoral, brachial) Is adequate wound hemostasis present? Non-sutured hemostatic agents including spray sealants may dislodge under negative pressure foam dressing DO NOT initiate V.A.C. Therapy until bleeding is well controlled Are medications or co-morbidities present that affect bleeding? Closely monitor patients on medications affecting bleeding times Clicking on the Education & Training link in will give you access to the Vascular Surgical Wounds of Lower Extremity module.

8 V.A.C. Therapy Warning Categories Infection 8 Infected wounds should be monitored closely and may require more frequent dressing changes than non-infected wounds. If there are any signs of the onset of systemic infection or advancing infection at the wound site, contact a physician immediately to determine if V.A.C. Therapy should be continued. In the event of a clinical infection, V.A.C. GranuFoam Silver is not intended to replace the use of systemic therapy or other infection treating regimens. V.A.C. Therapy should NOT be initiated on a wound with untreated osteomyelitis. If the V.A.C. Dressing is in place, but therapy is OFF for more than 2 consecutive hours, the patient s risk for infection may increase; either change V.A.C. Dressing and reinitiate therapy, or apply alternative dressing.

9 9 Considerations for V.A.C. Therapy Patients at Increased Risk of Infection With or without using V.A.C. Therapy, certain wound care patients are at high risk for infection Infection-weakened vessels can rupture and result in significant blood loss Protect all organs and vessels from direct V.A.C. Dressing contact More frequent V.A.C. Dressing changes may be required for any suspected infection in the wound Place at-risk patient in a monitored setting as MD deems appropriate Closely monitor patient for worsening condition V.A.C. Therapy should be considered only as an adjunct in the management of wound infection Use appropriate anti-infective agents and/or any other appropriate interventions (e.g. debridement, HBO) to combat wound infection V.A.C. Therapy should be ON (active) for 22 hours out of 24 hours If V.A.C. Dressing in place and therapy off for more than 2 hours, notify MD, remove V.A.C. Dressing, clean wound and: Replace with new V.A.C. Dressing or Replace with alternate dressing if unable to continue with V.A.C. Therapy

10 10 V.A.C. Therapy Warning Categories Foam Dressings Do not place foam dressings into blind or unexplored tunnels Help prevent foam dressing complications by: Documenting number and type of materials placed in the wound Maintaining a hour dressing change schedule (no less than 3x week unless on a skin or skin substitute graft) Using a non-adherent layer between wound bed and foam Using appropriate dressing in appropriate area of the wound, e.g, V.AC. WhiteFoam Dressings only in tunnels

11 11 Considerations for V.A.C. Therapy Patients at Increased Risk for Retained Foam Foam left in the wound for greater than the recommended time period may: Foster ingrowth of tissue into the wound, Create difficulty in removing foam, or Lead to infection or other adverse events. V.A.C. Dressings are radiolucent; they are not detectable by X-ray or other radiological methods Document on the drape or the V.A.C. foam quantity label or ruler (if provided) and in patient s medical chart: : Date, number and type of foam pieces placed in the wound Always count the total number of pieces removed and ensure the same number of foam pieces was removed as was placed Visualize the wound bed completely Patient positioning should be consistent for each V.A.C. Dressing change Move redundant tissue to allow wound bed visualization if needed Careful inspection of the wound to ensure all foam is removed is essential In the absence of infection, change V.A.C. Dressings at least every hours; no less than 3 times a week Rapid granulation formation in some wounds/patients may increase risk for foam adherence

12 V.A.C. Therapy Warning Categories Canister Size Allergy Resuscitation Use in Altered Environment ml canister is not recommended for use on patients: At high risk of bleeding or Unable to tolerate a large loss of fluid volume V.A.C. Therapy products are latex-free Patients with a known allergy to acrylic adhesives may react adversely to the V.A.C. Drape Seek medical attention if patient experiences a severe reaction The foam dressing, if in the thoracic area, may interfere with defibrillation efforts Joules may need to be adjusted to compensate or the dressing may need to be removed V.A.C. Therapy Units should not be taken into a Magnetic Resonance Imaging (MRI) environment as they are MRI unsafe V.A.C. Dressings, including V.A.C. GranuFoam Silver Dressings, may be used safely in the MRI suite However, foam may interfere with quality of image V.A.C. Therapy Units should not be taken into a Hyperbaric Oxygen Therapy (HBO) chamber as they are HBO unsafe V.A.C. GranuFoam and V.A.C. WhiteFoam Dressings have been used safely in the HBO chamber Ensure dressing tubing is not clamped during HBO therapy The V.A.C. GranuFoam Bridge Dressing contains additional synthetic materials which may pose a risk during HBO Therapy

13 13 V.A.C. Therapy Precaution Categories Standard precautions reduce the risk of transmission of blood borne pathogens Continuous therapy setting is recommended for: First 48 hours of V.A.C. Therapy Skin and skin substitute grafts Highly exudating wounds Tunnels and undermined areas Difficult dressing applications Painful wounds Intermittent or Dynamic Pressure Control * should not be used in the situations recommended for continuous therapy Patient Size and Weight may influence response to fluid loss and dehydration Spinal Cord Injury Patients may experience sudden changes in heart rate or blood pressure due to autonomic dysreflexia, which requires removal from V.A.C. Therapy Bradycardia may occur if foam dressing is placed close to the vagus nerve Wounds with enterocutaneous (enteroatmospheric) fistula require special dressing application techniques. Refer to V.A.C. Therapy Clinical Guidelines. Protect periwound skin from foam contact Circumferential dressings should be applied loosely do not tightly stretch drape as this may impair blood flow Check circulation distal to dressing frequently V.A.C. Therapy Unit Pressure Excursions May occur if therapy unit senses blockage Therapy unit may briefly go to -250mmHg or higher * Dynamic Pressure Control provided on V.A.C.Via and V.A.C.Ulta Therapy Systems.

14 14 Precautions for V.A.C. GranuFoam Silver Dressing Topical agents or solutions may adversely interact with the V.A.C. GranuFoam Silver Dressing: Saline-based solutions may compromise dressing effectiveness As with all V.A.C. Foam Dressings, the V.A.C. GranuFoam Silver Dressing should not be placed indirect contact with exposed vessels, anastomotic sites organs, or nerves Are organs or vessels visible and/or exposed? Preferably cover with a thick layer of natural tissue When natural tissue is not available, multiple layers of a non-adherent material can be used Be aware that a protective dressing may create a physical barrier that can interfere with silver ion delivery to the wound bed Dressings containing oil-based solutions may compromise the delivery of silver to the wound bed Electrodes or conductive gel should not be in contact with GranuFoam Silver Dressing during electronic monitoring (e.g. EKG) Interference with diagnostic imaging may occur in certain imaging situations with the V.A.C. GranuFoam Silver Dressing in place The 10% elemental silver in the V.A.C. GranuFoam Silver Dressing may cause tissue discoloration as seen with other silver-based dressings

15 15 Wound Healing Phases Hemostasis Inflammation Proliferation Remodeling

16 V.A.C. Therapy Creates an Environment that Promotes Wound Healing The application of uniform negative pressure delivered by V.A.C. Therapy induces a physical response (Macrostrain) and a biological response (Microstrain). Macrostrain draws wound edges together, removes exudate and infectious material, reduces edema, and promotes perfusion. Microstrain creates tissue microdeformation, causing cells to stretch. Cell stretch leads to cell migration and proliferation that result in the formation of granulation tissue. 16 1) Draws wound edges together 2) Removes infectious material 3) Reduces edema 4) Promotes perfusion 6) In vitro studies show that cell stretch under negative pressure stimulates cellular activity that results in granulation tissue formation 2 5) In vitro/in vivo studies show that foam contact with tissue under negative pressure creates tissue micro-deformation that leads to cell stretch 1,3 1. Saxena SM, et al. Vacuum Assisted Closure: Microdeformations of Wounds and Cell Proliferation. Plastic & Reconstructive Surgery, 2004;114(5): McNulty: AK, et al. Effects of negative pressure wound therapy on the fibroblast viability, chemotactic signaling and proliferation in a provisional wound (fibrin) matrix. Wound, 2007; 15: McNulty AK, et al. Effects of negative pressure wound therapy on cellular energetics in fibroblasts grown in a provisional wound (fibrin) matrix. Wound Repair and Regeneration Mar;17(3):192-9.

17 Macrostrain (Physical Response) 17 Contracts the wound under negative pressure, drawing the wound edges together 1) Draws wound edges together Provides direct and complete contact of the foam with the wound surface, allowing for even pressure distribution During compression of the hydrophobic open pore foam, the following occur at the wound site: Removal of infectious material and wound fluids Reduction of edema Promotion of perfusion to the wound bed 2) Removes infectious material 3) Reduces edema 4) Promotes perfusion

18 Microstrain (Biologic Response) 18 In vitro and in vivo* studies demonstrated that the effects of the biological response are initiated from the manifolding of negative pressure across the wound surface Foam contact with the wound creates areas of cell surface strain or micro-deformation leading to cell stretch (Saxena 2004) 5) Microdeformation leads to cell stretch When cells are stretched, they are stimulated to expand and grow, such as occurs with tissue expansion. In vitro V.A.C. Therapy studies have shown that activities following cell stretching include increased metabolic activity, fibroblast migration, cellular proliferation, and extracellular matrix production. (McNulty, 2007, 2009) All this leads to the formation of healthy granulation tissue in the wound bed 6) Cellular activity promotes granulation tissue formation *Based on in vitro and in vivo testing. KCI Data on file.

19 V.A.C. Therapy System: Family of Reticulated Open-Cell Foam Dressings 19 The Essential Component for Effective NPWT V.A.C. GranuFoam Dressing - Black Hydrophobic Open pore nature ( microns) provides uniform distribution of negative pressure at the wound site Aids wound contraction Conforms to wound bed V.A.C. GranuFoam Reticulated polyurethane ether foam V.A.C. WhiteFoam Dressing - White Hydrophilic, pre-moistened with sterile water Denser foam with greater pore size distribution Requires higher pressure mmhg to provide adequate negative pressure therapy distribution V.A.C. WhiteFoam Open Cell Polyvinyl alcohol foam V.A.C. GranuFoam Silver Dressing - Silver Hydrophobic Direct and complete silver contact with wound bed Open pore nature ( microns) provides uniform distribution of negative pressure at the wound site V.A.C. GranuFoam Silver Silver-bonded Reticulated polyurethane ether foam Artist rendering

20 20 SensaT.R.A.C. Technology An Essential Component of V.A.C. Therapy The only NPWT system that monitors pressure at the wound site and adjusts accordingly, patented SensaT.R.A.C. Technology ensures the prescribed negative pressure is maintained for optimal healing outcomes.

21 21 What is SensaT.R.A.C. Technology? SensaT.R.A.C. Pad Distributes negative pressure to individual sensing lumens Helps reduce tubing blocks and false alarms though enhanced fluid dynamics Enhances patient comfort with a low profile design and flexible material SensaT.R.A.C. Tubing Efficiently draws exudate away from the wound through the large inner lumen Independently monitors target pressure at the wound through the outer sensing lumens Allows for secure and convenient tubing connections Monitoring Software Continuously regulates negative pressure feedback Maintains prescribed negative pressure at the wound site by adjusting pump output Safety alarms alert caregivers if target pressure is not met or therapy is interrupted

22 22 Basic Application

23 23 Basic Dressing Application

24 24 Basic Dressing Application Click here for the application video located on KCI1.com

25 V.A.C. Therapy Alarm Troubleshooting System Alarm Action/Resolution Leak Alarm Use Leak detection procedure and the Seal Check Feature* to help find and repair leak For larger, highly exudating wounds, adjust intensity level to highest level to ensure a faster draw down and immediate seal May use skin prep over the drape to assist in making the drape more secure *Seal Check Feature can be found on VAC Ulta, InfoVAC and ActiVAC models by choosing that function directly or accessing the help menu through the [?] screen

26 V.A.C. Therapy Alarm Troubleshooting System Alarm Action/Resolution Low Pressure Alarm Check tubing for closed clamps kinks, crimps, or blockages Ensure dressing and drape have not sifted and blocked SensaT.R.A.C. pad s outer lumens Lower therapy unit and tubing to at or below wound level Ensure a 2.5 cm hole (quarter-sized) hole has been cut in the drape

27 V.A.C. Therapy Alarm Troubleshooting System Alarm Action/Resolution Blockage Alarm Inspect to ensure a 2.5 cm hole has been cut in drape Ensure the dressing and drape have not shifted underneath the Sensa T.R.A.C. Pad s outer lumens Lower therapy unit to or below wound Ensure Pad is located on a flat part of the body, avoid skin folds

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