Clinical trial demonstrated superior wound closure rates with PICO ◊ Compared to traditional NPWT in lower extremity ulcers1

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

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

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

1. 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.
2. 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.
3. 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.
4. Werdin F, Tenenhaus M, Rennekampff HO. Chronic wound care. Lancet. 2008 29;372(9653):1860-1862.
5. 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.
6. 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.
7. Smith & Nephew October 2017. Project Opal PICO 7 System Stability Testing, Initial Time Point. Internal Report. DS/17/253/R.
8. 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.

9. 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.

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