® V.A.C. Instill Therapy System Frequently Asked Questions 2 Frequently Asked Questions (FAQ) 1. What are the indications for V.A.C. Instill® ? The V.A.C. Instill® Therapy System is indicated for patients who would benefit from V.A.C.® Therapy coupled with controlled delivery and drainage of topical wound treatment solutions or suspensions over the wound bed. The first market segment where V.A.C. Instill® Therapy System will be introduced to, is the severely infected orthopedic and trauma wounds. 2. What are the indications for V.A.C. Instill® Therapy as compared to V.A.C.® Therapy? Both V.A.C. Instill® Therapy and V.A.C.® Therapy can be used on infected wounds. However, V.A.C. Instill® Therapy is more suitable for severe infections in deep wounds like acutely infected (< 8 weeks) orthopedic implants and deep trauma wounds. When infection is resolved, treatment may be continued with standard V.A.C.® Therapy. 3. What are the specific benefits of V.A.C. Instill® Therapy? V.A.C. Instill® Therapy combines the benefits of V.A.C.® Therapy with the benefits of fluid instillation to help promote wound healing. Automated instillation and drainage of fluids at user-defined intervals helps treat infections. The wound is rinsed regularly and infectious material and bacterial toxins are removed without the need to change the dressing. When V.A.C. Instill® Therapy is used to treat wound infections with an antiseptic or antibiotic solution, longer dressing change intervals may be considered on the advice of the treating physician. 4. Is V.A.C. Instill® Therapy the same as standard surgical drainage? No. Standard surgical drainage is an old treatment modality. It will create channels of preference for fluid flow. V.A.C. Instill® Therapy is a high technology, multifaceted, automated therapy system, which distributes the fluid evenly over the entire wound bed. This leads to more efficient irrigation as compared to standard surgical drainage. 5. Can I treat both acute and chronic infections with V.A.C. Instill® Therapy? Information collected so far suggests that mainly acute wound infections (infections not older than 8 weeks) are suitable for V.A.C. Instill® Therapy. More chronic infections are less likely to respond to V.A.C. Instill® Therapy because topical agents to effectively treat chronic infections are not (yet) available. 6. Is V.A.C. Instill® Therapy effective in the presence of biofilm? Biofilm is often present in chronic infections. It consists of a matrix produced by the bacteria present which protects them from antibacterial agents. Because implanted materials, such as hip and knee prostheses are lacking blood supply, these are especially susceptible to the formation of biofilm. At this moment there is no topical agent available that is compatible with the V.A.C. Instill® Therapy System which works against biofilm. 7. What evidence is available for clinical efficacy of V.A.C. Instill® Therapy, in addition to V.A.C.® Therapy? Case studies have demonstrated that fluid delivery and removal is very effective and that this related to reduction in infection parameters. For publications on V.A.C. Instill® Therapy please refer to the reference list at the end of this document. 8. What can be said about the fluids to be used with V.A.C. Instill® Therapy? Only fluids that are compatible with the V.A.C. Instill® Therapy System can be used, such as aqueous solutions within physiological pH range. For more information about compatible and non-compatible solutions, please see the V.A.C. Instill® Therapy operations manual and the table below. KCI does not claim clinical efficacy nor indication for use of products listed. For more information about intended use and clinical efficacy of the fluids please contact the manufacturer of the solutions. Only fluids mentioned in the list below have been tested for material compatibility with the V.A.C. Instill® Therapy System. Other solutions should not be used with the V.A.C. Instill® Therapy System because of the risk of non-compatibility. Compatible* 䡵 Saline 䡵 Lavasept® 䡵 Acetic Acid – up to 0.25% 䡵 Prontosan® 䡵 Dermacyn® 䡵 Sulfamylon (Mafenide Acetate) – up to 5% 䡵 Bacitracin® 䡵 Nebacetin® 䡵 Silver nitrate – up to 0.5% 䡵 Lidocaine® 䡵 Dakin’s Solution (Sodium Hypochlorite) – up to 1/4 strength * Non compatible** Octenisept ® 䡵 Hydrogen peroxide 䡵 Solutions that are alcohol based or contain alcohol 䡵 The listing of a solution or pharmaceutical product is not an endorsement or recommendation by KCI for use with the V.A.C. Instill® System. Brand names referenced are not trademarks of KCI, its affiliates, or licensors. ** Brand names referenced are not trademarks of KCI, its affiliates, or licensors. 3 4 9. Why is Octenisept® contraindicated for use with the V.A.C. Instill® Therapy System? Compatibility testing conducted with V.A.C.® Dressing components indicated that both, V.A.C.® GranuFoam® and V.A.C. Instill® WhiteFoam, as well as V.A.C.® Drape are adversely affected when in contact with Octenisept®. 10. Why are alcohol based solutions contraindicated for the use with V.A.C. Instill® Therapy System? Alcohol (Ethanol) is not compatible with wound tissue and thus should not be used with the V.A.C. Instill® Therapy System. 11. Why is hydrogen peroxide contraindicated for use with the V.A.C. Instill® Therapy System? Hydrogen peroxide is contraindicated for use with the V.A.C. Instill® Therapy System due to the effervescent nature of this solution. The V.A.C. Instill® Therapy System dressing is a closed system that is not vented to the atmosphere. Therefore, any effervescence produced by the hydrogen peroxide may remain in the wound bed, potentially leading to air emboli. In addition, hydrogen peroxide is considered highly cytotoxic and deleterious to wound healing. 12. Why are solutions within a pH-range of 6.0 – 7.4 recommended for use? This recommendation is intended to provide clinicians with a general guideline for judging the appropriateness of a particular solution, when not otherwise stated in the V.A.C. Instill® Therapy System operations manual. A solution within this range is considered acceptable for use because it is close to the physiological pH-range (for compatible solutions, please see question 8 on page 3). 13. What testing has been done to ensure solutions are safe for use with the V.A.C. Instill® Therapy System? Because of the variety of solutions that can be used with the V.A.C. Instill® Therapy System, representative members of solution categories have been tested for material compatibility with all components of our V.A.C. Instill® Dressings. Please refer to the material compatibility list in this document for the solutions tested. 14. When should I use antibiotics and when should I use antiseptics? The choice of which fluid to use is the responsibility of the physician. KCI can not give recommendations about which instillation fluid to use with the V.A.C. Instill® Therapy System. KCI does not claim clinical efficacy or indications for use of compatible products. KCI can only give a material compatibility statement for those fluids listed above about the use with the V.A.C. Instill® Therapy System. 15. What should I do if I want to change from one instillation fluid to a different instillation fluid? If solution “x” is being used and the physician wants to change to solution “y” (assuming that they are both compatible with V.A.C. Instill® Therapy System), the following is advised. Stop delivery of fluid “x” and connect the Instillation tube to saline or a comparable rinsing solution. Use this fluid to rinse the system (including the dressing). Hereafter disconnect the saline and connect the fluid container with fluid “y”. Continue V.A.C. Instill® Therapy. 16. Should I continue systemic antibiotic treatment? Yes. V.A.C. Instill® Therapy is an adjunct to systemic antibiotic therapy. The topical treatment with V.A.C. Instill® Therapy helps remove infectious material and clear infection. 17. Should topical antibiotics be used with the V.A.C. Instill® Therapy? An advantage of applying topical antibiotics may be that high concentrations are achieved at the site of infection. It is solely at the discretion of the treating physician whether or not to use topical antibiotics, as long as they are compatible with the V.A.C. Instill® Therapy System. The use of topical antibiotics is considered highly controversial amongst physicians, because of the risk of hypersensitivity and the potential induction of bacterial resistance. Therefore it is the decision of the treating physician. 18. When should I stop V.A.C. Instill® Therapy? The discontinuation of V.A.C. Instill® Therapy is based on the wound condition and infection parameters, according to the clinician’s judgment. Infection should be resolved after 10–15 days of V.A.C. Instill® Therapy. Alternative treatments should be considered if no signs of improvement are observed after that period of time. 19. Which dressing should be used for which wound type? When using the V.A.C. Instill® Therapy, the main treatment goal is to resolve infection. We therefore recommend the V.A.C. Instill® WhiteFoam Dressing, which is available with embedded tubing, especially for severely infected wounds such as infected orthopedic implants. The advantage is that the wound status can be judged by evaluating the color of the foam on a day to day basis (ref. 7). V.A.C.® GranuFoam® can also be used when the wounds are more easily accessible. However, please be aware that the V.A.C.® GranuFoam® takes up more fluid than the V.A.C.® WhiteFoam Dressing so the consumption of instillation fluids may be higher when using V.A.C.® GranuFoam®. 20. Who should be trained before using V.A.C. Instill® Therapy? Use of V.A.C. Instill® requires specialist expertise in a hospital environment. Proper skills and training are required to apply and operate the V.A.C. Instill® Therapy System. Both physicians and the nursing staff should be properly trained in the use of this advanced wound treatment modality. Training can be organized in the hospital, or medical personnel could be invited to one of the KCI sponsored trainings. 5 6 21. How to measure the instillation time? The instillation time is the time needed to fill the dressing with fluid. This will obviously depend on the size and geometry of the wound as well as on the type of foam used. Thus, instillation time needs to be determined before the onset of therapy by carrying out the following steps: 1. 2. 3. 4. 5. 6. Put dressing under vacuum Close roller clamp of the instillation tube Close vacuum clamp of the system Open Instill clamp Open roller clamp Take the time from opening the roller clamp until the dressing is filled with fluid, by using a stopwatch 7. Close roller clamp 8. Document the time 9. Program this time as instillation time in the therapy unit As soon as the instillation time has been measured, do not change the height of the fluid container, as this would require re-evaluation of the instillation time. Avoid overfilling the foam since this may lead to tenting of the drape and possible maceration of the peri-wound area. 22. How do I know the hold times for instillation fluids? The hold or dwell time is the time that the fluid is in contact with the wound bed and depends on the characteristics of the fluid used. For more information please refer to the instructions for use of the selected fluid or contact the manufacturer. 23. What are the time ranges for each mode of V.A.C. Instill® Therapy? Program Vacuum time Instillation time Hold time Adjustment range 5 minutes to 12 hours 1 second to 2 minutes 1 second to 60 minutes 24. Can I monitor the volume of fluids instilled to and removed from the wound? The current V.A.C. Instill® Therapy System does not automatically measure fluid volumes delivered to and removed from the wound. Manually, the fluid balance can be estimated by measuring the amount of fluid delivered in time (looking at level of fluid reservoir) and the amount of fluid in the canister during that same time. The values should be approximately the same. If more fluid ends up in the canister this could be due to the drainage of normal wound exudate plus the instilled fluid. However, when less fluid is collected in the canister than instilled, fluid might have been resorbed from the wound or may have accumulated in deeper cavities. In this case, the dressing should be removed and the wound be carefully inspected. 25. Will there be alarms if I forget to put the tubing within the clamps or if the irrigation fluid container is empty? No. It is very important to carefully inspect the V.A.C. Instill® Therapy System before the automated therapy is started. Also, please check regularly if there is sufficient fluid available for instillation. We strongly recommend product training for both physicians and nurses before starting to use the V.A.C. Instill® Therapy System. 26. If I want to continue with V.A.C.® Therapy following the treatment with V.A.C. Instill® Therapy, do I have to place a second order for a standard V.A.C.® Therapy System? No. The V.A.C. Instill® Therapy System can also be used to deliver standard V.A.C.® Therapy only without using the instillation function. Literature 1 2 3 4 5 6 7 Wolvos et al, Ostomy Wound Management 2004, 50 (11); 55–66 Bernstein et al, Wounds 2005, 17 (2), 37–48 Jerome D, J Wound Ostomy Continence Nurs. 2007, 34 (2), 1919–194 Kirr et al, Zentralbl Chir 2006, 131, S79–S83 Riepe and Schneider, Zentralbl Chir 2006, 131, S157–S159 Lehner and Bernd, Zentralbl Chir 2006, 131, S160–S164 Fleischmann, Vacuum Instillation Therapy, in Christian Willy, The Theory and Practice of Vacuum Therapy, 2006 chapter 5, 33–40 7 Singapore KCI Medical Asia Pte Ltd. 50 Ubi Crescent #01-01 Singapore 408568 Tel +65 6742 6686 Fax +65 6749 6686 Toll Free 1 800 742 9929 www.kci-medical.com KCI Europe Holding B.V. Parktoren, 6th Floor Van Heuven Goedhartlaan 11 1181 LE Amstelveen The Netherlands Tel +31 (0) 20 426 0000 Fax +31 (0) 20 426 0099 www.kci-medical.com © 2007 KCI Licensing, Inc. All Rights Reserved. All trademarks designated herein are property of KCI Licensing, Inc, its affiliates and licensors. Those KCI trademarks designated with the “®” symbol are registered and those designated with “TM” are considered to be proprietary trademarks or are pending trademark applications in at least one country where this product / work is commercialized. Most KCI products referred to herein are subject to patents or patent applications. KCII 1062-08-07-SGP / K-101-1528 / 08.07 KCI Corporate Office 8023 Vantage Drive San Antonio TX 78230 U.S.A. T (free) 1 800 531 5396, extension 6335 Tel +1 210 255 6335 Fax +1 210 255 6991 www.kci-medical.com
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