SCIENCE, PRACTICE AND EDUCATION DOI: 110.35279/jowm202110.07 Multi-centre study demonstrating safety and efficacy of an upgraded sNPWT system on closed surgical wounds Sudheer L Karlakki , FRCS (Orth), MSc,The Robert Jones and Agnes Hunt Orthopaedic NHS Foundation Trust, Oswestry, UK; Jessica R Evans , MBBS, FRCS Dept. of Research and Innovation and General Surgery, Queen Elizabeth the Queen Mother Hospital, Margate, UK Simon P Booth , RN (Dip), MScQueen Victoria Hospital, East Grinstead, UK Jason KF Wong , PhD,FRCS (Plast), Blond McIndoe Laboratories, Division of Cell Matrix and Regenerative Medicine, University of Manchester, Manchester, UK; Department of Burns and Plastic Surgery, Manchester University Foundation Trust, Wythenshawe Hospital, Manchester Academic Health Science Centre, Manchester, UK Lyn Wilson , , Pinderfields Hospital, Wakefield, UK Steven LA Jeffrey , FRCS (Plast), Wound Healing Practice Development Unit, Birmingham City University, Birmingham, UK Rohit Makhija , FRCS (Glasg, GenSurg) Peterborough City Hospital, Peterborough, UK Yves Harder , MD, Department of Plastic, Reconstructive and Plastic Aesthetic Surgery, Ente Ospedaliero Cantonale (EOC), Lugano, Switzerland; Faculty of Bio- medical Sciences, Università della Svizzera Italiana (USI), Lugano, Switzerland Iain McNamara , FRCS (Tr and Orth) MD, Norfolk and Norwich University Hospital, Norwich, UK; University of East Anglia, Norwich, UK Mike Reed , MD, FRCS, Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital, Ashington, UK David E Barnes , MSc, FRCS, Plast Edin St Andrews Centre for Burns and Plastic Surgery, Broomfield Hospital, Chelmsford, UK Sarah Megginson , MSc, Biostatistics, Smith+Nephew, Hull, UK Brian Gilchrist , MSc, RN, Global Clinical Strategy, Smith+Nephew, Watford, UK Correspondence: Sudheer.karlakki@nhs.net · Conflicts of Interest: This study was sponsored and funded by Smith + Nephew. Sarah Megginson and Brian Gilchrist were employees of Smith + Nephew at the time of this manuscript’s preparation and submission. Keywords: Closed surgical incisions; PICO 7; single-use negative pressure wound therapy; skin flaps; split-thickness skin grafts; surgical site complications ABSTRACT Background Surgical site complications (SSCs) pose a major post- operative challenge. Single-use negative pressure wound therapy (sNPWT) systems have been shown to be effective for reducing SSCs. An upgraded sN- PWT system (PICOTM 7) with improved functional performance and ease-of-use was assessed in a prospective, single-arm study. The study aimed to assess if the system was a safe and effective therapy for delivering consistent negative pressure. Methods Between November 2018 and May 2019, eligible patients across 11 sites with a closed abdominal or knee arthroplasty incision, skin graft or flap, were en- rolled. Postoperatively, patients received sNPWT for up to 7 days with follow-up until 30 days. Endpoints included the ability to maintain a consistent nega- tive pressure for the intended duration, complication rates, clinician and patient usability and satisfaction and serious adverse events. Results The device was capable of delivering consist- ent negative pressure across all assessed surgical wounds and was statistically equivalent to the ref- erence negative pressure (-80.2 mmHg) (n=46; p=0.002). Low complication rates were observed within 30 days post-surgery. High levels of clinician usability (>90%) and patient satisfaction (95%) were reported. No serious device-related adverse events were reported. Conclusions The study demonstrated the functional performance, JOURNAL OF WOUND MANAGEMENT OFFICIAL JOURNAL OF THE EUROPEAN WOUND MANAGEMENT ASSOCIATION 47
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