英国のNICEがPICO（TM）のメドテック・イノベーション・ブリーフィングを公表

AsiaNet 74206 （1161）

【ロンドン、ニューヨーク2018年7月3日PR Newswire=共同通信JBN】

＊縫合後の切開部位の合併症軽減の予防的使用に関して

グローバルな医療技術企業であるスミス・アンド・ネフュー（Smith & Nephew）（LSE: SN）（NYSE：SNN）は、英国の国立医療技術評価機構（NICE）がPICO単回陰圧創傷治療システム（sNPWT）使用に関するメドテック・イノベーション・ブリーフィング（MIB）を公表したと発表した。

（Photo: https://mma.prnewswire.com/media/713195/Smith_Nephew_sNPWT.jpg ）

MIBは、手術部位合併症（SSC）の予防において、標準的な術後ドレッシングよりPICOの予防的使用の方が潜在的により有効な代替手段であると報告している。これはSSC予防用のNPWT装置についてNICEが公表した唯一のMIBである。

術創からの合併症は経済的、人的に大きな重荷で、毎年NHS（国民保健サービス）に約10億ポンド（参照1）の負担となっており、英国および世界中で罹患率、死亡率の大きな部分を占めている。最近の世界創傷治癒学会連合（World Union of Wound Healing Societies）の合意ガイドラインでは、手術部位感染（SSIs）の最大60％が予防可能と報告されている（参照2）。

PICOシステムの予防的使用は、SSCのリスクが高い患者において、SSI、離開（創傷断裂）を含むSSCを減少させるのに有効であることが証明されている（参照7）。

PICOドレッシングは、術創と、切開自体によって自然発生した創傷周囲領域全体に均一かつ一貫してNPWTを届ける独自のAIRLOCK（TM）技術を採用している（参照3）、（参照4）。この独自機能は、標準的なドレッシングと比較して、術後の流体、腫れ、関連した縫合後の切開部位周辺の張りを減少させることによって、創傷合併症のリスクを軽減するのに役立つよう設計されている（参照5）、（参照6）。こうした動作の組み合わせは、2つの最も一般的なSSCである外科的創傷裂開（参照7）とSSI（参照7）のリスクを軽減するのに役立つ。

エビデンスは、開腹手術後の創傷縫合の際にPICOを予防的に使用すると、合併症を減らし、病院からの早期退院で平均8日以上、入院期間が短縮され（参照8）＊、NHSにとって入院負担が軽減される可能性があることを示している。一次性股関節や膝関節形成術を受けている患者では、PICOでのケアが、標準的ドレッシングでケアした場合と比較して、高リスク患者（BMIが35以上、あるいはASAが3以上）にかかる費用を1人当たり7000ポンド以上節約できたと推計されている（参照9）＊＊。

NICEの調査結果についての詳細は次を参照。http://www.smith-nephew.com/PICOMIB

ワージング病院（Worthing Hospital）のポーリン・ホワイトハウス一般・大腸外科医長は「当院で中程度から高リスクの切開手術にPICOを導入したところ、手術部位の表面感染が大幅に減少したことにすぐ気付いた。現在、病院全体にPICOを導入、他の専門科目の感染合併症でも同様の減少が見られている」と語った。

MIBは、臨床医、管理者、調達責任者による現場での意思決定を支援するための、デバイスおよび診断技術に関する客観的な情報である。それらはNHSのアドバイス （https://www.nice.org.uk/about/what-we-do/our-programmes/nice-advice ）であり、新しい医療機器やその他の医療機器の利用を検討しているNHS、ソーシャルケアコミッショナー、スタッフを支援するのが目的である。ブリーフィングは、諸組織が類似の情報を地元で作成する必要性を回避し、スタッフの時間とリソースを節約するのに役立つ。MIBは、NHSイングランドによって委託され、NHSの5年フォワードビューのサポートを受け、具体的には新たな治療法、診断法におけるイノベーションを加速するいくつかのステップの1つとして、作成されている。

MIBの一環として、NICEはさまざまなメタ分析と無作為対照化試験（RCT）の公開済み、ピアレビュー済みデータを徹底的にレビューした。SSC減少におけるPICOの有効性は、10件のRCTと多くの観察研究で分析された。最近公表された患者1839人のメタ分析は、予防的に使用されたPICOが、標準的ケアと比較して縫合後の術創でSSIを58％と大幅に減少させたとして、その有効性を実証した（参照5）＊＊＊。

PICOは、病院と地域の両方の環境での使用に適しており、縫合後の術創部位を含む多くの適応症に対し認可されている。

スミス・アンド・ネフューのパオロ・ディビンチェンツォ高度創傷管理担当上級副社長は、次のように語った。「NICE MIBsはNHSの諸機関にとって素晴らしいリソースであり、英国以外の医療システムでもよく使われる参考資料である。今日われわれは、手術部位の合併症の率を減らそうとしている臨床医にとって、PICOの予防的使用が効果的代替手段であるとNICE MIBが支持してくれたことを喜ばしく思う。これは、経済的、臨床的により良い結果を出すべく努力している彼らの力となり、彼らがリスクのある患者や治療に対し、自信を持ってPICOを使用できるようになるだろう」「PICOによって、われわれはスミス・アンド・ネフューを、負担を軽減し、より良い臨床的、経済的成果を提供することで、現在のケア水準を向上させ続けていく先駆的ソリューションを提供する最前線に立たせることができている。PICOは、費用対効果の高いポータブルなソリューションで、患者の転帰の改善に大きく寄与する、命にかかわる縫合後の手術切開部の感染の減少という重要な臨床成果を示してくれた」

▽スミス・アンド・ネフュー（Smith & Nephew）について

スミス・アンド・ネフューは、医療従事者が人々の生活を改善するのを支援することに専心するグローバルな医療技術企業である。整形外科的再建（http://www.smith-nephew.com/about-us/what-we-do/orthopaedic-reconstruction ）、高度創傷管理（http://www.smith-nephew.com/about-us/what-we-do/advanced-wound-management ）、スポーツ医学 （http://www.smith-nephew.com/about-us/what-we-do/sports-medicine ）、外傷・四肢 （http://www.smith-nephew.com/about-us/what-we-do/trauma ）で指導的立場にあるスミス・アンド・ネフューには、約1万5000人の従業員がおり、100カ国以上（http://www.smith-nephew.com/about-us/where-we-operate ）にプレゼンスがある。2017年の年間売上高は約48億ドル。スミス・アンド・ネフューはFTSE100（LSE：SN、NYSE：SNN）のメンバーである。

スミス・アンド・ネフューの詳細については、ウェブサイト（http://www.smith-nephew.com ）http://www.smith-nephew.com/news-and-media ）を参照するか、Twitterの@SmithNephewplc （http://www.twitter.com/smithnephewplc ）をフォロー、あるいはFacebook.com（http://www.facebook.com/smithnephewplc ）のSmithNephewplcにアクセスを。

（TM）はスミス・アンド・ネフュー（Smith & Nephew）の商標。これら特定商標は米国特許商標庁に登録されている。

＊50人の患者の研究、入院期間の短縮：PICO 6.1日、対照群 14.7日、pは0.019未満。

＊＊20人の患者のRCT（無作為対照化試験）に基づく計算。

＊＊＊メタ分析には、10件のRCTと6件の観察研究が含まれていた。 SSIの減少（16研究）には1839人の患者（2154の切開）が含まれていた。PICO 5.2％、対照群 12.5％、pは0.0001未満。入院期間の平均減少（8試験を含む）0.47日、p 0.0001未満。

参照：

   1. Guest J et al, Health economic burden that different wound types impose

on the UK's National Health Service. Int Wound J 2016; doi: 10.1111/iwj.12603

    2. World Union of Wound Healing Societies (WUWHS) Consensus Document.

Closed surgical incision management: understanding the role of NPWT. Wounds

International, 2016

    3. Data on File. DS/17/253/R. Project Opal PICO 7 System Stability Testing

- Initial Time Point. October 2017

    4. Malmsjo M et al. Biological effects of a disposable, canisterless

Negative Pressure Wound Therapy system (in-vitro). Eplasty 2014; 14:e15

    5. Selvaggi F et al., New Advances in Negative Pressure Wound Therapy

(NPWT) for Surgical Wounds of Patients Affected with Crohn's Disease. Surgical

Technology International XXIV; 83- 89

    6. Loveluck et al (2016) Biomechanical modeling of forces applied to closed

incision during NPWT eplasty16e20

    7. Strugala, V. and Martin, R. Meta-analysis of comparative trials

evaluating a prophylactic single-use negative pressure wound therapy system for

the prevention of surgical site complications. Surgical Infections (2017). DOI

10.1089/sur.2017.156

    8. O'Leary, Donal Peter et al. 2017. "Prophylactic Negative Pressure

Dressing Use in Closed Laparotomy Wounds Following Abdominal Operations."

Annals of Surgery. Jun 265(6): 1082-1086

    9. Nherera LM, Trueman P, Karlakki SL. Cost-effectiveness analysis of

single-use negative pressure wound therapy dressings (sNPWT) to reduce surgical

site complications (SSC) in routine primary hip and knee replacements. Wound

Repair Regen. April 2017. doi:10.1111/wrr.12530

PDF：https://mma.prnewswire.com/media/713194/PICO_Single_Use_Negative_Pressure_Wound_Therapy.pdf

ソース：Smith & Nephew

UK's NICE Publishes a Medtech Innovation Briefing on PICO(TM) for the Prophylactic Use in Surgically Closed Incisions to Reduce Surgical Site Complications

PR74206

LONDON and NEW YORK, July 3, 2018 /PRNewswire=KYODO JBN/--

     Smith & Nephew (LSE: SN) (NYSE: SNN), the global medical technology

business, announces that the UK's National Institute for Health and Care

Excellence (NICE) has issued a Medtech innovation briefing (MIB) on the use of

PICO Single Use Negative Pressure Wound Therapy (sNPWT).

(Photo: https://mma.prnewswire.com/media/713195/Smith_Nephew_sNPWT.jpg )

    The MIB reports the prophylactic use of PICO as a potentially more

effective alternative to standard surgical dressings in the prevention of

surgical site complications (SSCs). This is the first and only MIB published by

NICE on an NPWT device for preventing SSCs.

    Complications from surgical incisions are a significant economic and human

burden, costing an approximate GBP1 billion[1] to the NHS each year and

contributing to significant morbidity and mortality in the UK and globally. A

recent World Union of Wound Healing Societies consensus guidelines reports that

up to 60% of surgical site infections (SSIs) are preventable[2].

    The prophylactic use of the PICO system is proven to be effective in

reducing SSCs, including SSIs and dehiscence (wound rupturing) of the surgical

incision, in patients at elevated risk of SSCs[7].

    The PICO dressing has a proprietary AIRLOCK(TM) Technology that uniformly

and consistently delivers NPWT across a surgical incision and the surrounding

zone of injury generated naturally by the incision itself[3],[4]. This

proprietary feature is designed to help reduce the risk of wound complications

by reducing post-operative fluid, swelling and associated tension around a

closed surgical incision compared with standard dressings[5], [6]. The

combination of these actions helps reduce the risk of surgical wound

dehiscence[7]  and SSIs[7], the 2 most common SSCs.

    Evidence shows how the prophylactic use of PICO resulted in fewer

complications, and in earlier discharge from hospitals, reducing length of

stay, on average by more than 8 days, in closed laparotomy wounds after

abdominal surgery[8]*, which has the potential to release bed days for the NHS.

In patients undergoing primary hip and knee arthroplasties, it was estimated

that care with PICO enabled cost savings of more than GBP7,000 per high-risk

patient (BMI greater than or equal to35 or ASA greater than or equal to3)

compared with care with standard dressings[9]**.

    Read more about NICE's finding here: http://www.smith-nephew.com/PICOMIB

    Ms Pauline Whitehouse, Consultant General and Colorectal Surgeon, Worthing

Hospital, said, "Following the introduction of PICO into our Trust for

moderate- to high-risk incisions, we quickly noticed a significant reduction in

superficial surgical site infections. We have now introduced PICO across the

Trust and are seeing similar reductions in infective complications for other

specialities."

    MIBs are objective information on device and diagnostic technologies to aid

local decision-making by clinicians, managers and procurement professionals.

They are NICE advice

[https://www.nice.org.uk/about/what-we-do/our-programmes/nice-advice ],

designed to support NHS and social care commissioners and staff who are

considering using new medical devices, and other medical or diagnostic

technologies. The briefing will help avoid the need for organisations to

produce similar information locally, saving staff time and resources. MIBs are

commissioned by NHS England and produced in support of the NHS 5-Year Forward

View, specifically as one of a number of steps that will accelerate innovation

in new treatments and diagnostics.

    As part of the MIB, NICE conducted a thorough review of the published and

peer-reviewed data from a variety of meta-analyses and randomised controlled

trials (RCTs). The effectiveness of PICO in reducing SSCs has been examined in

10 RCTs and multiple observational studies. A recently published 1,839 patient

meta-analysis demonstrated the efficacy of PICO, used prophylactically,

significantly reducing SSIs by 58% in closed surgical incisions compared with

standard care[5]***.

    PICO is suitable for use in both hospital and community settings, and is

approved for a number of indications, including surgically closed incision

sites.

    "NICE MIBs are a great resource for NHS organisations, and are often a

reference used by healthcare systems beyond the UK. Today we are delighted to

see the NICE MIB support for the prophylactic use of PICO as an effective

alternative for clinicians who look to reduce their rates of surgical site

complications. This will provide them with the confidence to use PICO for their

at-risk patients and procedures, in support of their efforts to achieve better

economic and clinical outcomes," said Paolo Di Vincenzo, Smith & Nephew's SVP

of Advanced Wound Management. "With PICO, we are keeping Smith & Nephew at the

forefront of delivering pioneering solutions that continue to improve current

standards of care, by reducing the burden and delivering better clinical and

economic outcomes. PICO has shown significant clinical results in reducing

life-threatening infections on closed surgical incisions, which has contributed

significantly to improved patient outcomes, in a cost-effective portable

solution."

    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

[http://www.smith-nephew.com/about-us/what-we-do/orthopaedic-reconstruction ],

Advanced Wound Management

[http://www.smith-nephew.com/about-us/what-we-do/advanced-wound-management ],

Sports Medicine

[http://www.smith-nephew.com/about-us/what-we-do/sports-medicine ] and Trauma &

Extremities [http://www.smith-nephew.com/about-us/what-we-do/trauma ], Smith &

Nephew has around 15,000 employees and a presence in more than 100 countries

[http://www.smith-nephew.com/about-us/where-we-operate ]. Annual sales in 2017

were almost $4.8 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN,

NYSE:SNN).

    For more information about Smith & Nephew, please visit our website

http://www.smith-nephew.com [http://www.smith-nephew.com/news-and-media ],

follow @SmithNephewplc on Twitter [http://www.twitter.com/smithnephewplc ] or

visit SmithNephewplc on Facebook.com [http://www.facebook.com/smithnephewplc ].

    Forward-looking Statements

    This document may contain forward-looking statements that may or may not

prove accurate. For example, statements regarding expected revenue growth and

trading margins, market trends and our product pipeline are forward-looking

statements. Phrases such as "aim", "plan", "intend", "anticipate",

"well-placed", "believe", "estimate", "expect", "target", "consider" and

similar expressions are generally intended to identify forward-looking

statements. Forward-looking statements involve known and unknown risks,

uncertainties and other important factors that could cause actual results to

differ materially from what is expressed or implied by the statements. For

Smith & Nephew, these factors include: economic and financial conditions in the

markets we serve, especially those affecting health care providers, payers and

customers; price levels for established and innovative medical devices;

developments in medical technology; regulatory approvals, reimbursement

decisions or other government actions; product defects or recalls or other

problems with quality management systems or failure to comply with related

regulations; litigation relating to patent or other claims; legal compliance

risks and related investigative, remedial or enforcement actions; disruption to

our supply chain or operations or those of our suppliers; competition for

qualified personnel; strategic actions, including acquisitions and

dispositions, our success in performing due diligence, valuing and integrating

acquired businesses; disruption that may result from transactions or other

changes we make in our business plans or organisation to adapt to market

developments; and numerous other matters that affect us or our markets,

including those of a political, economic, business, competitive or reputational

nature. Please refer to the documents that Smith & Nephew has filed with the

U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act

of 1934, as amended, including Smith & Nephew's most recent annual report on

Form 20-F, for a discussion of certain of these factors. Any forward-looking

statement is based on information available to Smith & Nephew as of the date of

the statement. All written or oral forward-looking statements attributable to

Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake

any obligation to update or revise any forward-looking statement to reflect any

change in circumstances or in Smith & Nephew's expectations.

    (TM) Trademark of Smith & Nephew.  Certain marks registered US Patent and

Trademark Office.

    * 50-patient study; length of stay reduced: PICO 6.1 days; control group

14.7 days; p less than 0.019

    ** Calculations based on a 220-patient RCT

    *** Meta-analysis included 10 RCT and 6 observational studies. Reduction in

SSI (16 studies) included 1,839 patients (2,154 incisions); PICO 5.2%; control

group 12.5%; p less than 0.0001. Mean reduction in hospital length of stay (8

studies included): 0.47 days; p less than 0.0001

    References:

    1. Guest J et al, Health economic burden that different wound types impose

on the UK's National Health Service. Int Wound J 2016; doi: 10.1111/iwj.12603

    2. World Union of Wound Healing Societies (WUWHS) Consensus Document.

Closed surgical incision management: understanding the role of NPWT. Wounds

International, 2016

    3. Data on File. DS/17/253/R. Project Opal PICO 7 System Stability Testing

- Initial Time Point. October 2017

    4. Malmsjo M et al. Biological effects of a disposable, canisterless

Negative Pressure Wound Therapy system (in-vitro). Eplasty 2014; 14:e15

    5. Selvaggi F et al., New Advances in Negative Pressure Wound Therapy

(NPWT) for Surgical Wounds of Patients Affected with Crohn's Disease. Surgical

Technology International XXIV; 83- 89

    6. Loveluck et al (2016) Biomechanical modeling of forces applied to closed

incision during NPWT eplasty16e20

    7. Strugala, V. and Martin, R. Meta-analysis of comparative trials

evaluating a prophylactic single-use negative pressure wound therapy system for

the prevention of surgical site complications. Surgical Infections (2017). DOI

10.1089/sur.2017.156

    8. O'Leary, Donal Peter et al. 2017. "Prophylactic Negative Pressure

Dressing Use in Closed Laparotomy Wounds Following Abdominal Operations."

Annals of Surgery. Jun 265(6): 1082-1086

    9. Nherera LM, Trueman P, Karlakki SL. Cost-effectiveness analysis of

single-use negative pressure wound therapy dressings (sNPWT) to reduce surgical

site complications (SSC) in routine primary hip and knee replacements. Wound

Repair Regen. April 2017. doi:10.1111/wrr.12530

PDF:  

https://mma.prnewswire.com/media/713194/PICO_Single_Use_Negative_Pressure_Wound_Therapy.pdf

Source:  Smith & Nephew