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Ewma Document: Negative Pressure Wound Therapy EWMA DOCUMENT: NEGATIVE PRESSURE WOUND THERAPY OVERVIEW, CHALLENGES AND PERSPECTIVES Jan Apelqvist,1, 2 (editor) MD, PhD, Associate Professor Christian Willy,3 (co-editor) MD, PhD, Professor of Surgery Ann-Mari Fagerdahl,4 RN, CNOR, PhD Marco Fraccalvieri,5 MD Malin Malmsjö,6 MD, PhD, Professor Alberto Piaggesi,7 MD, Professor of Endocrinology Astrid Probst,8 RN Peter Vowden,9 MD, FRCS, Professor 1. Department of Endocrinology, University Hospital of Malmö, 205 02 Malmö, Sweden 2. Division for Clinical Sciences, University of Lund, 221 00 Lund, Sweden 3. Department of Trauma & Orthopedic Surgery, Septic & Reconstructive Surgery, Bundeswehr Hospital Berlin, Research and Treatment Center for Complex Combat Injuries, Federal Armed Forces of Germany, 10115 Berlin, Germany 4. Department of Clinical Science and Education, Karolinska Institutet, and Wound Centre, Södersjukhuset AB, SE-118 83 Stockholm, Sweden. 5. Plastic Surgery Unit, ASO Città della Salute e della Scienza of Turin, University of Turin, 10100 Turin, Italy 6. Clinical Sciences, Lund University, Lund, Sweden. 7. Department of Endocrinology and Metabolism, Pisa University Hospital, 56125 Pisa, Italy 8. Kreiskliniken Reutlingen GmbH, 72764 Reutlingen, Germany 9. Faculty of Life Sciences, University of Bradford, and Honorary Consultant Vascular Surgeon, Bradford Royal Infirmary, Duckworth Lane, Bradford, BD9 6RJ, United Kingdom Editorial support and coordination: Niels Fibæk Bertel, EWMA Secretariat Corresponding author: Jan Apelqvist, [email protected] The document is supported by unrestricted educational grants from: Acelity, BSN medical, Genadyne, Mölnlycke Health Care, Schülke & Mayr GmbH, Smith & Nephew and Spiracur. The document is published as a deliverable for the SWAN iCare project, www.swan-icare.eu, which is partially funded under the ICT Smart components and smart systems integration programme (FP7-ICT) as part of the Research and Innovation funding programme by the European Commission. This article should be referenced as: Apelqvist, J., Willy, C., Fagerdahl, A.M. et al. Negative Pressure Wound Therapy – overview, challenges and perspectives. J Wound Care 2017; 26: 3, Suppl 3, S1–S113. © EWMA 2017 All rights reserved. No reproduction, transmission or copying of this publication is allowed without written permission. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, mechanical, electronic, photocopying, recording, or otherwise, without the prior written permission of the European Wound Management Association (EWMA) or in accordance with the relevant copyright legislation. Although the editor, MA Healthcare Ltd. and EWMA have taken great care to ensure accuracy, neither the editor, MA Healthcare Ltd. nor EWMA will be liable for any errors of omission or inaccuracies in this publication. Published on behalf of EWMA by MA Healthcare Ltd. Editor: Rachel Webb Publisher: Anthony Kerr Designer: Lindsey Butlin Published by: MA Healthcare Ltd, St Jude’s Church, Dulwich Road, London, SE24 0PB, UK Tel: +44 (0)20 7738 5454 Email: [email protected] Web: www.markallengroup.com S 2 JOURNAL OF WOUND CARE VOL 26 NO 3 SUPPLEMENT EWMA DOCUMENT 2017 Contents Abbreviations 6 5. Treatment 19 Development of the range of indications: NPWT 1. Introduction 8 1990–2015 19 Aim 9 Goals of the treatment and the scientific background 19 Mechanism of action: NPWT on open wounds 19 2. Methodology and terminology 10 Creating a moist wound environment and removal of Search history and document development 10 exudate 20 Terminology 10 Removal of oedema 20 Mechanical effects on wound edges 20 3. The principles of NPWT 11 NPWT induced change in perfusion 22 Short history 11 Angiogenesis and the formation Functional principle of NPWT 11 of granulation tissue 24 Example of application 11 Change in bacterial count, bacterial clearance and Mechanism of action of NPWT 12 immunological effects 24 Effect on the wound 12 Molecular mechanisms in wound healing 26 Handling 12 Effect on topical antibiotic concentrations 27 Patient comfort 14 General points 27 Functional principle of NPWTi 14 Pressure level/suction strength 28 Mechanism of action of NPWTi 14 Vacuum source 29 Functional principle of ciNPT 14 Intermittent or continuous modus 30 Lack of mechanism of action ciNPT 15 Wound fillers 31 Differences in mechanism of action in ciNPT and NPWT Morphology of the wound 31 15 Exuding wounds 31 Wounds at risk of ischaemia 32 4. Review of the literature evidence on Infected wounds 32 NPWT 16 Tendency to the formulation of excessive granulation tissue 32 Literature search 16 Wound contact layers 32 Search period and search keywords 16 NPWT and dermal replacement 33 Results 17 Protections of tissue and organs 33 Development in the number of annual publications 17 Pain treatment 34 NPWT and evidence-based medicine 17 NPWT and adjunct therapies 34 Criteria of evidence-based medicine 17 Indications in specialties 35 Particularities of NPWT and NPWTi 18 NPWT in acute traumatology and for the closure of Particularities of ciNPT 18 dermatofasciotomy wounds 35 Periprosthetic infections of the hip and knee joint 37 JOURNAL OF WOUND CARE VOL 26 NO 3 SUPPLEMENT EWMA DOCUMENT 2017 S 3 NPWT in the treatment of osteomyelitis and surgical site Mechanism of action of ciNPT 58 infection 37 Lateral tension 58 Exposed tendon, bone and hardware 38 Tissue perfusion 58 NPWT in the treatment of acute burns and scalds 39 Oedema 58 Plastic and reconstructive surgery 40 Haematoma and seroma 58 Abdominal surgery 41 Reduction of surgical site infection rate 58 Enterocutaneous fistula 43 ciNPT systems 59 Direct fascial closure 43 When to start, when to stop (achieved endpoint) 60 Hernia development 44 Length of hospital and intensive care unit stay 44 6. Patient perspective 63 Mortality 44 Overall quality of life 63 Other aspects 44 Physical aspects 64 Cardiovascular surgery 45 Pain 64 Vascular surgery 46 Physical discomfort 64 NPWT of infected blood vessels and vascular grafts 46 Sleep 64 Lymphocutaneous fistulas 47 Psychological aspects 65 Non-healing wounds 49 Body image 65 Leg ulcers 49 Stress 65 NPWT in leg ulcers 49 Anxiety 65 Pressure ulcers 50 Staff competence 66 NPWT in pressure ulcers 50 Social aspects 66 Diabetic foot ulcer 50 Isolation and stigma 66 NPWT in diabetic foot ulcers 51 Family and friends 66 Cautions and contraindications 52 Patient and family Risk of bleeding 53 caregiver education 66 Exposed vessels and vascular prostheses 53 Necrotic wound bed 53 7. Organisation of NPWT 68 Untreated osteomyelitis 53 Organisation of care 68 Malignant wounds 53 NPWT at different levels 68 NPWT and instillation 53 Short- and long-term goals 68 Functional principle NPWT with instillation 54 Reimbursement 68 Methods of action 54 NPWT in different settings 69 NPWTi versus irrigation-suction drainage 55 Hospital 69 Indications for NPWTi 55 Primary care 70 Fluids for NPWTi 55 Home care 70 ciNPT 56 Basic concepts in the organisation of NPWT treatment Literature review: randomised trials 57 71 S 4 JOURNAL OF WOUND CARE VOL 26 NO 3 SUPPLEMENT EWMA DOCUMENT 2017 Access and service support 71 Health economics and reimbursement with regard to Inventory and single-purchase models 71 wounds 84 Leasing model 72 Wounds treated with NPWT 84 Free rental model 72 Cost-effectivness 84 Disposable devices 72 Components of costs 84 Managed service 72 Evaluation of comparative and non-comparative studies: Service support 73 resource use and economic cost 84 How can continuous high-quality treatment be guaranteed? Complex surgical, postsurgical wounds and acute or 73 traumatic wounds 85 Service support with regard to the patient 73 NPWT in chronic wounds 85 Responsibility 74 NPWT in diabetic foot ulcers 86 Education and providing a network supporting the patient 74 General findings 87 Minimum requirements for staff education 74 Methodological considerations 87 Questions to be considered before initiating therapy 75 A paradigm shift in NPWT: inpatient to outpatient care, a service to a product 87 8. Documentation, communication and patient safety from the medico-legal 10. Future perspectives 89 perspective 76 Technological developments 89 Implications of cross-sectional NPWT 76 Hospital-based system with increased sophistication 89 Off-label use 77 Simplified single use devices 89 Contractual terms New material for wound fillers 89 and agreements 78 Systems with integrated sensors Patient safety issues 78 for long-distance monitoring 90 Patient safety checklist for out-patient NPWT 78 Changes in demand: supporting and constraining factors Communication 79 91 Documentation 79 Expanded indications 91 Legal and litigation issues 80 Increased focus on evidence and cost containment 91 Changes in organisation of care and community care 92 9. Health economics 81 Organisation of care 81 Appendices 114 Factors related to healing of hard-to-heal wounds 82 Technologies in the treatment of wounds 82 Comparing treatment interventions 83 Cost-effectiveness studies 83 Modelling studies 83 Controversies regarding health economic evaluations 83 JOURNAL OF WOUND CARE VOL 26 NO 3 SUPPLEMENT EWMA DOCUMENT 2017 S 5 Abbreviations • ACS: Abdominal compartment syndrome • FGF-2: Fibroblast growth factor-2 • ABRA: Abdominal re-approximation anchor system • HR: Hazard ratio • ADR: Acellular dermal replacement • HIF: Hypoxia-induced factor • bFGF: Basic fibroblast growth factor • IE: Immediate early • BMI: Body mass index • IM: Intermittent mode • Cdc42: Cell division control protein 42 •
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