8 January 2013

Clinical data indicates PICO◊ NPWT System reduces surgical site complications in Caesarean-section patients

Smith & Nephew (LSE: SN, NYSE: SNN), the global medical technology business, today announces two independent clinical evaluations that indicate favourable results in preventing surgical site infections (SSI) when using the PICO Negative Pressure Wound Therapy System (“PICO”)(1) post operatively following a Caesarean section.

The first study followed a group of 50 patients who were deemed of higher risk of contracting an infection post-C-section due to being clinically obese, but whose closed surgical incisions were treated with a protocol including PICO.  The results(2), presented at the recent Wounds UK conference in Harrogate by Lindsey Bullough and Diane Wilkinson of the Royal Albert Edward Infirmary in Wigan, showed that there were no infections and zero re-admissions.

“Obesity is strongly associated with the risk of developing an infection and increases the more overweight the woman is,” said Lindsey Bullough, who is a Tissue Viability Nurse. “An obese patient undergoing a C-section is particularly vulnerable given that the resulting incisions have a higher risk of infection.”

"I had an emergency C-section and was a bit nervous about my recovery since I had had an infection with my first C-section," said Michelle Mann, a mother of three and a patient who was part of the Wigan evaluation. "For me, PICO was as easy as wearing a belt.  It didn't restrict my movements at all and it was easy to remove for showering. I didn't have an infection after this surgery and overall my recovery was much better the second time around."

"Infections impact not only the mother and her family but also the health service costs in relation to antibiotic use, GP time and midwifery care,” said Diane Wilkinson, Infection Control, Junior Matron at Royal Albert Edward Infirmary.

Second study supports reduced surgical site infections with PICO

The results of a second new post-operative strategy in the management of C-sections have also been presented(4), showing an 83% reduction in surgical site infections (SSI).  The average cost of a re-admission due to post-operative SSI is calculated as above $50,000 .4

This study followed a centre near Seattle, Washington in the U.S. that had  adopted a similar protocol including PICO as part of a standard treatment bundle for post-surgical management of C-sections in high-risk patients (BMI≥35 or 2 or more risk factors, like diabetes, steroid therapy within 48 hours from surgery, autoimmune diseases, immune suppression and so forth).   

The clinical poster was presented by Jeanette Harris, Infection Preventionist and Evelyn Hickson, Perinatal Clinical Nurse Specialist from MultiCare Health Systems  at the 27th Annual Clinical Symposium on Advances in Skin and Wound Care (Las Vegas, 20-23 October 2012).

 “Our commitment to ensure we can help reduce the human cost of wounds and at the same time conserve resources, spurred the innovation of PICO,” concluded Andy Boyes, President, Europe, Advanced Wound Management division, Smith & Nephew. “We are pleased that the outcome of these studies reinforces the benefits of PICO in minimising the risk of post-operative complications in this group of patients.”

Notes

(1)The PICO NPWT system was launched in Europe and achieved FDA clearance in the U.S. in 2012. The company has ensured ethnographic market research incorporated customer feedback into the PICO system’s design to provide a patient-friendly experience that also addresses the needs and preferences of clinicians and payers. PICO makes the therapeutic benefits of NPWT available to more patients because it is easily accessed from the shelf, easily applied and simple for the patient to manage. The PICO system is indicated for chronic, acute and traumatic wounds; subacute and dehisced wounds; partial-thickness burns; ulcers (such as diabetic or pressure); flaps and grafts; and closed surgical incisions. The PICO system is as easy to apply as a conventional wound dressing, reducing the need for the intensive training, staff time and administrative paperwork associated with traditional NPWT. The simple application technique can be viewed online via an MS Tag included on the packaging.

(2) Clinical poster “Changing Wound Care Protocols to Reduce Post-Operative Caesarean Section Complications” was presented at the Wounds UK conference in Harrogate (12-14 November) by Lindsey Bullough and Diane Wilkinson of the Royal Albert Edward Infirmary in Wigan. 

According to research from the Health Protection Agency in the UK the rate of surgical site infection in women with a BMI<18.5 undergoing a C-section was 4.7 per cent, increasing to 19.3 per cent with a BMI≥35.   (HPA 2012 Risk of infection from caesareans at nearly 10  per cent:  http://www.hpa.org.uk/NewsCentre/NationalPressReleases/2012PressReleases/120801Infectionriskfromcsection/ accessed October 2012)

An audit conducted within the Wrightington, Wigan and Leigh Trust in the UK from August to December 2011 highlighted a higher incidence of wound infection in women with a BMI>35. In response to these  findings, the clinicians made recommendations in accordance with NICE guidance, using Smith & Nephew’sbarrier dressing OPSITE Post-Op Visible (3) on all uncomplicated cases. 

On all patients with BMI>35, the clinicians applied PICO immediately post surgery and left it in situ for one week. Following training and education,  the team of midwives managing the C-section patients diligently adopted the new protocol and supported the clinicians during the study. 

A total of 50 patients with the higher BMIs were treated with PICO. In this group there were no infections and zero re-admissions.

 (3) OPSITE Post-Op Visible unique and innovative design allows constant monitoring of the wound without the need to disrupt the healing process through unnecessary dressing changes.

(4) Clinical poster “Using a Multi-Faceted Active Change Process and Infection Prevention to Reduce Post Op C-Section Infections” was presented by Jeanette Harris, Infection Preventionist and Evelyn Hickson, Perinatal Clinical Nurse Specialist from MultiCare Health Systems  at the 27th Annual Clinical Symposium on Advances in Skin & Wound Care (Las Vegas, 20-23 October 2012). 

The study followed a centre near Seattle that had adopted a new protocol including PICO as part of a standard treatment bundle for post-surgical management of C-sections in high-risk patients (BMI≥35 or 2 or more risk factors, like diabetes, steroid therapy within 48 hours from surgery, autoimmune diseases, immune suppression and so forth).

The result was a further reduction of 83% in surgical site infections in C-sections, from the already low incidence of 0.5% (6 surgical site infections (SSI) ) over a total of 1200 C-sections in 2011, with only one infection in 2012 through mid-November in patients who had the complete SSI reduction bundle applied). 

The average cost of a re-admission due to post-operative SSI is calculated as above $50,000.

For more information about PICO, please visit www.mypico.com or www.possiblewithpico.com or follow the @woundcare Twitter handle for the latest news from the Advanced Wound Management division of Smith & Nephew.

For more information about OPSITE Post-Op Visible please visit

www.opsitepostop.com.

For more information about Smith & Nephew, please visit www.smith-nephew.com.

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About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping improve people's lives.  With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine, Trauma and Clinical Therapies, Smith & Nephew has almost 11,000 employees and a presence in more than 90 countries. Annual sales in 2011 were nearly $4.3 billion.  Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).

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