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New RCT demonstrates PICO™ sNPWT halving surgical site infections in caesarean sections

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13 November 2018

Smith & Nephew (LSE: SN, NYSE: SNN), the global medical technology business, welcomes the publication of a new study which concludes that PICO Single Use Negative Pressure Wound Therapy System (sNPWT) significantly reduced surgical site infections (SSIs) compared with standard dressings in high-risk obese women undergoing caesarean section.1 Wound exudate was also significantly reduced with PICO sNPWT use.1

The randomised study was conducted at five centres in Denmark in 876 women of mean age 32 years undergoing elective or emergency caesarean section all with a pre-pregnancy BMI equal to or higher than 30. The women received either PICO sNPWT or standard dressings.

The use of PICO sNPWT resulted in a 50% reduction in the incidence of SSIs, with only 4.6% developing infection with PICO, compared to 9.2% when standard dressings were used. The results were similar after adjustment for risk factors including pre-pregnancy BMI equal to or above 35. Fewer women had wound exudate with PICO sNPWT than those using standard dressings.

The lead author Nana Hyldig of Odense Universitetshospital, Denmark, said: “The study shows that the PICO dressing reduces the risk of SSI. Also, our experience shows that women are comfortable with the PICO dressing and have less pain. It is our hope that the results from the study will benefit patients and health care systems around the world.”

The PICO dressing, including a proprietary AIRLOCK™ Technology layer, uniformly and consistently delivers NPWT across a surgical incision and the surrounding zone of injury.2,3 This pioneering dressing, 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.4,5 The combination of these actions helps reduce the risk of surgical wound dehiscence6* and surgical site infections (SSIs)6*, the two most common surgical site complications.

PICO is suitable for use in both hospital and community settings, and is approved for a number of indications, including surgically closed incision sites.

“This study provides important insights into optimising clinical management strategies for preventing SSIs, which are an increasing concern for healthcare providers and their patients around the world.” said Paolo Di Vincenzo, Senior Vice President Global Marketing, Smith & Nephew. “It is the latest addition to the growing body of literature supporting PICO sNPWT as an effective prophylactic option for SSI prevention, and follows the recent NICE Medtech innovation briefing on PICO for use in surgically closed incisions to reduce surgical site complications,” added Paolo Di Vincenzo.

For more information see http://www.smith-nephew.com/pico-obs/

Media

Dave Snyder
Smith & Nephew
+1 (978) 749-1440

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 www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

To learn more about what we do to help reduce surgical site complications, please visit www.closertozero.com

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Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office. @October 2018 15633

* Meta-analysis included 10 RCT & 6 observational studies. Reduction in SSI (16 studies included): 1839 patients (2154 incisions); PICO 5.2%; control group 12.5%; p<0.0001.

References:

1.  Hyldig N, Vinter CA, Kruse M, et al. Prophylactic incisional negative pressure wound therapy reduces the risk of surgical site infection after caesarean section in obese women: A pragmatic randomised clinical trial. BJOG. 2018 Aug 1. [Epub ahead of print] Available at: British Journal of Obstetrics and Gynaecology https://obgyn.onlinelibrary.wiley.com/doi/abs/10.1111/1471-0528.15413
2. Data on File. DS/17/253/R. Project Opal PICO 7 System Stability Testing - Initial Time Point. October 2017
3. Malmsjö M et al. Biological effects of a disposable, canisterless Negative Pressure Wound Therapy system (in-vitro). Eplasty 2014; 14:e15
4.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
5. Loveluck et al (2016) Biomechanical modelling of forces applied to closed incision during NPWT eplasty16e20
6. 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