LONDON and NEW YORK, July 3,
2018 /PRNewswire/ --
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:
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)
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
£1 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™ 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 £7,000 per high-risk
patient (BMI ≥35 or ASA ≥3) 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,
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,
Advanced Wound Management, Sports Medicine and Trauma &
Extremities, Smith & Nephew has around 15,000 employees and a
presence in more than 100 countries. 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, follow @SmithNephewplc on
Twitter or visit SmithNephewplc on Facebook.com.
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registered US Patent and Trademark Office.
* 50-patient study; length of stay reduced: PICO 6.1 days;
control group 14.7 days; p<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<0.0001. Mean
reduction in hospital length of stay (8 studies included): 0.47
days; p<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. Malmsjö 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