PICO NPWT & high-risk orthopaedic patient benefits - New clinical data shows PICO◊ canister-free NPWT system has positive benefits for high-risk orthopaedic patients

Smith & Nephew (LSE: SN, NYSE: SNN), the global medical technology business, has presented new clinical data that demonstrates the benefits of using its single-use, canister free NPWT system, PICO, in high-risk orthopaedic patients.

In a symposium at the European Federation of Orthopaedics (EFORT), three leading orthopaedic surgeons - Mr. Sudheer Karlakki (UK), Dr. Matthias Brem (Germany) and Prof. Sandro Giannini (Italy) - presented the preliminary results of randomized controlled studies they had carried out in their individual facilities. The three studies compared the use of PICO to reduce the incidence of post-surgical complications against the standard care in primary and revision arthroplasty and spinal fractures. All of the studies reported a positive outcome for patients when using PICO post-surgery.

“PICO is a fantastic product for orthopaedic surgeons,” says Diogo Moreira-Rato, President of Smith & Nephew Europe and Canada. “The new data presented at EFORT shows how its clinical effectiveness, coupled with the extreme portability provided by the exclusive canister-free technology, may help patients to have a safe and early discharge, without interfering with their mobilisation.

“Since its launch, we have seen fantastic results when the product is used in a community setting and we are now focused on demonstrating the benefits of PICO following orthopaedic surgery.  We are committed to reducing the human and economic costs of wounds and this evidence supports the notion that NPWT can help to reduce surgical site infections (SSIs).”

Clinical data results

Mr. Sudheer Karlakki, Clinical Director and Consultant Orthopedic Surgeon at the Robert Jones & Agnes Hunt Hospital, in Oswestry UK, shared the preliminary results of a randomized controlled trial, evaluating a post-operative wound management protocol based on PICO in 220 primary hip and knee arthroplasty patients.

“The aim of the study was to evaluate if, using PICO, it was possible to predictably and safely discharge patients early without worrying about post-discharge wound complications, says Mr. Karlakki. “The data showed PICO reduced the overall length of stay particularly in high-risk patients with Body Mass Index above 35. The study group had also experienced less infections and leakages compared to the control group.”

Dr. Matthias Brem (Klinikum Nuremberg, Germany) reviewed the studies investigating the mode of action of NPWT on closed incisions: reduction of lateral tension across the incision and reduction of oedema and hematoma and seroma formation seem to play a fundamental role in how NPWT influences the healing of surgical incisions^1-2. Dr. Brem shared the preliminary results of a randomized controlled study where he is treating surgical incisions after fractures of the spine with either PICO or a standard surgical dressing.

“The clinical protocol included ultrasound examination to measure postoperative seromas on the 5^th and 10^th day post-surgery. Preliminary results show a reduction of the number of dressing changes and the time to perform a dressing change in the PICO group. The current data showed a reduction of seroma formation after five days from surgery,” says Dr. Brem.

Prof. Sandro Giannini (Istituto Ortopedico Rizzoli, Bologna, Italy), shared the preliminary results of a randomized controlled study, comparing PICO vs. standard care in revision hip and knee arthroplasty. He says: “Revision arthroplasties have an incidence of complications significantly higher than primary operations, with major risk factors being the formation of hematoma, prolonged drainage, ASA score, obesity and diabetes. The hip arm of the study is complete and has shown lower ASEPSIS and VAS scores (indicating better quality wound healing and less pain) in the PICO group. The preliminary results of the knee arm of the study show the same pattern.”

Data from several agencies demonstrates the size of the problem generated by post-surgical complications to National Healthcare Systems. In a report published in 2013 by Public Health England, on 170,158 hip replacement procedures (0.7%) had a diagnosis of SSIs with a corresponding 0.6% of 182,566 knee replacement procedures suffering the safe outcome.³

According to Sudheer Karlakki, this data may be underestimated: “Patient reported outcome measures (PROMs) from the UK National Joint Registry in 2013 reports that 10% (corresponding to 8,498 patients) of all the primary hip surgery patients have experienced wound problems after the operation and 7.3% (corresponding to 6,726 patients) had to be re-admitted to hospital after the operation. For primary knee surgery 13.4% (corresponding to 11,825 patients) experienced wound problems after the operation and 9.6% (9,295 patients) had to be re-admitted after the operation⁴. Whilst not all the wound problems reported by patients may be serious infections, it is clear that management of the post-operative wound is an important patient concern.”

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Notes to editors

 These are preliminary results only and more information will be available upon study completion.  

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About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people's lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 11,000 employees and a presence in more than 90 countries. Annual sales in 2013 were more than $4.3 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).

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