Smith+Nephew (LSE: SN, NYSE: SNN), the global medical technology
business, today announces the publication of a new randomized
controlled trial (RCT) which demonstrated that the use of PICO
Single Use Negative Pressure Wound Therapy System (sNPWT)
significantly reduced wound area, depth and volume compared to
traditional negative pressure wound therapy (tNPWT) in patients
with lower extremity ulcers.1*
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The results of the clinical trial were first published in Wound
Repair and Regeneration.
Chronic wounds cause significant morbidity and mortality and can
lead to significant medical costs.2 In the United States alone,
chronic wounds affect six million people, with increasing numbers
anticipated in growing elderly and diabetic populations.2 One study
showed that in a single year, chronic wounds cost ~$9.7 billion in
the USA.3 Venous or arterial insufficiency, diabetes, and
local-pressure effects are the most common causes of chronic
wounds.4 Chronic wounds can be managed with traditional negative
pressure wound therapy (tNPWT),5 but it can be complex to use and
limits patient mobility.6
The study was conducted at 16 centers in the US and two in
Canada, comparing the efficacy and safety of PICO sNPWT with tNPWT
in the management of patients with lower extremity ulcers with a
longer than four weeks duration over the period of 12 weeks.1 In
total, 164 patients were randomized to receive either PICO sNPWT or
tNPWT.
In this study PICO showed superior outcomes in a decrease in
wound area (73.1% vs 31.3% for tNPWT), a reduction in wound depth
(48.1% vs 12.7% for tNPWT) and a reduction in wound volume (61% vs
30% increase in tNPWT group).1* Twice as many wounds achieved wound
closure at 12 weeks with PICO sNPWT vs tNPWT.1 There were 44% fewer
dressing changes with PICO sNPWT vs tNPWT and 3.4 days longer wear
time.1 Overall satisfaction was also greater with PICO sNPWT, and
fewer patients had adverse events with PICO sNPWT than with
tNPWT.1
“For certain types of diabetic foot and leg wounds, PICO does a
superb job of addressing the limitations of traditional NPWT,
especially in routine clinical practice” said Paolo Di Vincenzo,
Smith+Nephew Senior Vice President, US Commercial, AWM. “We are
delighted that the clinical evidence points to an improvement over
traditional NPWT for patients with lower extremity ulcers.”
The unique PICO sNPWT dressing includes the proprietary
AIRLOCK◊ Technology for uniform and consistent delivery of
therapeutic NPWT across a wound and the surrounding zone of
injury.7 By minimizing the need for fillers and reducing dressing
change frequency compared with traditional NPWT1, PICO sNPWT helps
to facilitate the natural healing process, contributing to faster
time to wound closure, improved quality and distribution of
granulation tissue and more consistent re-epithelialization.8 PICO
sNPWT has a strong evidence base with 103 published papers of which
21 are published RCTs and 65 are unique clinical studies.1,9
To learn more about PICO sNPWT see www.possiblewithpico.com
- ends -
For detailed product information, including indications for use,
contraindications, precautions and warnings, please consult the
product’s applicable Instructions for Use (IFU) prior to use. PICO
7 is not indicated for use with compression therapy.
* ITT n=161; p<0.001 for area; p=0.014 for depth;
p=0.013 for volume for LS means tNPWT group consisted of devices
from leading manufacturers.
References
- Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A
Prospective, Randomized, Controlled Clinical Trial on the Efficacy
of a Single‐use Negative Pressure Wound Therapy System, Compared to
Traditional Negative Pressure Wound Therapy in the Treatment of
Chronic Ulcers of the Lower Extremities. Wound Rep Regen. 2019.
https://doi.org/10.1111/wrr.12727.
- Powers JG, Higham C, Broussard K, Phillips TJ. Wound healing
and treating wounds: Chronic wound care and management. J Am Acad
Dermatol. 2016;74(4):607-25.
- Bickers DR, Lim HW, Margolis D, et al. The burden of skin
diseases: 2004. A joint project of the American Academy of
Dermatology Association and the Society for Investigative
Dermatology. J Am Acad Dermatol. 2006;55(3):490-500.
- Werdin F, Tenenhaus M, Rennekampff HO. Chronic wound care.
Lancet. 2008 29;372(9653):1860-1862.
- Birke-Sorensen H, Malmsjo M, Rome P, et al. Evidence-based
recommendations for negative pressure wound therapy: treatment
variables (pressure levels, wound filler and contact layer)--steps
towards an international consensus. J Plast Reconstr Aesthet Surg.
2011;64 Suppl:S1-16.
- Hurd T, Trueman P, Rossington A. Use of a portable, single-use
negative pressure wound therapy device in home care patients with
low to moderately exuding wounds: a case series. Ostomy Wound
Manage. 2014;60(3):30-36.
- Smith & Nephew October 2017. Project Opal PICO 7 System
Stability Testing, Initial Time Point. Internal Report.
DS/17/253/R.
- Brownhill R, Bell A, Hart J, Webster I & Huddleston E.
Pre-clinical Assessment of a No-canister, Ultra- portable, Single
use Negative Pressure Wound Therapy (sNPWT) System* in a Porcine
Model of Wound Healing: Unlocking its Mode of Action. Poster
presented at the Advanced Wound Care (SAWC) Conference, 7-11 May
2019, San Antonio,Texas.
-
Strugala, V., 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, Vol. 18, No. 00, 2017.
About Smith+Nephew Smith+Nephew is a portfolio medical
technology business that exists to restore people’s bodies and
their self-belief by using technology to take the limits off
living. We call this purpose ‘Life Unlimited’. Our 16,000+
employees deliver this mission every day, making a difference to
patients’ lives through the excellence of our product portfolio,
and the invention and application of new technologies across our
three global franchises of Orthopedics, Advanced Wound Management
and Sports Medicine & ENT. Founded in Hull, UK, in 1856, we now
operate in more than 100 countries, and generated annual sales of
$4.9 billion in 2018. Smith+Nephew is a constituent of the FTSE100
(LSE:SN, NYSE:SNN). The terms ‘Group’ and ‘Smith+Nephew’ are used
to refer to Smith & Nephew plc and its consolidated
subsidiaries, unless the context requires otherwise.
For more information about Smith+Nephew, please visit www.smith-
nephew.com and follow us on Twitter, LinkedIn, Instagram or
Facebook.
To learn more about how we can help you get CLOSER TO ZERO◊
delay in wound healing, please visit www.possiblewithpico.com
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 organization 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.
◊ Trademark of Smith+Nephew. Certain marks registered US Patent
and Trademark Office.
PCEE76-14182-0919
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Enquiries Media Aaron Cohen aaroncohenpr@gmail.com
301-633-6773 or Dave Snyder Smith+Nephew +1 (978) 749-1440
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