Kliniska data visar att Smith & Nephews Pico-system minskar sårkomplikationer hos patienter med kejsarsnitt

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Det globala medicinteknikbolaget Smith & Nephew har offentliggjort två nya oberoende kliniska utvärderingar som båda visar på positiva resultat vid förebyggandet av sårinfektioner genom användandet av bolagets Pico Negative Pressure Wound Therapy System 1 (vakuumassisterad sårbehandling) postoperativt efter kejsarsnitt.

Den första studien följde femtio patienter som på grund av övervikt bedömdes löpa högre risk för sårinfektioner efter genomförda kejsarsnitt. Som en följd av detta behandlades dessa patienter enligt ett vårdprotokoll där Pico ingick som en del. Resultaten2, som presenterades vid Wounds UK-konferensen i Harrowgate, Storbritannien av Lindsey Bullough och Diane Wilkinson från Royal Albert Edwardssjukhuset i Wigan, visade att inga infektioner uppstod och att inga patienter behövde återbehandlas.

– Övervikt innebär en ökad risk för infektioner och risken ökar ju mer överviktig kvinnan är, säger Lindsey Bullough som är sjuksköterska specialiserad på sårläkning. En överviktig patient som genomgår ett kejsarsnitt är särskilt utsatt, då operationen i sig medför en högre risk för infektioner.

– Jag fick göra ett akut kejsarsnitt och var orolig för hur det skulle gå, eftersom jag fick en infektion den första gången jag gjorde ett sådant, berättar Michelle Mann, trebarnsmor och deltagare i studien i Wigan. Att använda Pico var lika lätt som att bära ett bälte. Det hindrade inte min rörelseförmåga och var lätt att ta av när jag skulle duscha. Jag fick inga infektioner och jag återhämtade mig mycket snabbare den här gången.

– Infektionerna påverkar inte bara modern och familjen, utan också sjukvårdskostnaderna i form av kostnader för antibiotika, läkartid och mödravård, säger Diane Wilkinson, sjuksköterska med inriktning på infektionskontroll vid Royal Albert Edwardssjukhuset i Wigan.

Ytterligare studie visar på färre infektioner med Pico
Nyligen har också resultatet från en ny postoperativ strategi för kejsarsnitt presenterats. I denna studie som följde utvecklingen vid ett sjukhus nära Seattle, USA, minskade antalet sårinfektioner med 83 procent3. Den genomsnittliga kostnaden för återbehandling med anledning av postoperativa infektioner uppgår till 50 000 USD, motsvarande cirka 350 000 svenska kronor.

Sjukhuset använde ett vårdprotokoll där Pico ingick som en del i en standardiserad metod för behandling av högriskpatienter, det vill säga patienter med ett BMI högre än 35, alternativt två ytterligare riskfaktorer, som till exempel diabetes, steroidterapi inom 48 timmar från operation, immunförsvarssjukdomar, eller nedsatt immunförsvar.

Resultaten4presenterades av Jeanette Harris, som arbetar med infektionsförebyggande åtgärder, samt Evelyn Hickson, specialist på perinatal vård, båda från MultiCare Health Systems, i samband med ”The 27th Annual Clinical Symposium on Advances in Skin & Wound Care” som genomfördes i Las Vegas, USA 20-23 oktober 2012.

– Vi vill hjälpa till att minska de mänskliga kostnaderna i form av smärta och andra besvär som kan följa på sår, samtidigt som vi sparar på tillgängliga resurser. Vi är stolta över att de studier som presenterats understryker nyttan av Pico när det gäller att minimera riskerna för postoperativa komplikationer i denna patientgrupp. Detta var drivande bakom vårt utvecklingsarbete, säger Carina Ekbladh, Nordic Brand Manager, Smith & Nephew.

För mer information, kontakta:
Carina Ekbladh, Nordic Brand Manager, Smith & Nephew, +46 70 545 33 10, carina.ekbladh@smith-nephew.com

Om Smith & Nephew
Smith & Nephew är ett globalt medicintekniskt företag med målet att förbättra människors levnadsvillkor. Med ledande positioner inom ortopedisk rekonstruktion, avancerad sårbehandling, sportmedicin, trauma och klinisk terapi har Smith & Nephew nästan 11 000 medarbetare och närvaro i över 90 länder. Försäljningen 2011 uppgick till nära 4,3 miljarder USD.

Noter

1      Pico NPWT-systemet lanserades i Europa och fick godkännande av FDA i USA 2012. Bolaget har genomfört etnografiska marknadsundersökningar och återfört resultat från kundundersökningar i designprocessen för att skapa en patientvänlig upplevelse, samtidigt som hänsyn tas till behov och krav från sjukvårdsorganisationen i sig. Pico gör de terapeutiska fördelarna med Negative Pressure Wound Therapy tillgängligas för fler patienter, eftersom systemet är både lättillgängligt och lätt att använda för patienten. Systemet används bland annat för kroniska, akuta, traumatiska, subakuta och ulcerösa sår, liksom för operationssår som gått upp.

2      “Changing Wound Care Protocols to Reduce Post-Operative Caesarean Section Complications” presenterades vid Wounds UK-konferensen i Harrowgate, Storbritannien, av Lindsey Bullough och Diane Wilkinson från Royal Albert Edwardssjukhuset. Enligt forskningsresultat som presenterats av brittiska Health Protection Agency är risken för en kvinna med ett BMI mindre än 18,5 att drabbas av sårinfektion i samband med ett kejsarsnitt 4,7 procent. För en kvinna med ett BMI högre än 35 är motsvarande siffra 19,3 procent.

Se vidare: HPA 2012 Risk of infection from caesareans at nearly 10 per cent: http://www.hpa.org.uk/NewsCentre/NationalPressReleases/2012PressReleases/120801Infectionriskfromcsection/ accessed October 2012

En genomlysning inom Withingthon, Wigan och Leigh Trust I Storbrittannie, genomförd under perioden augusti till december 2011 belyste också en större andel sårinfektioner hos kvinnor med ett BMI på över 35.

På samtliga kvinnor med ett BMI överstigande 35 användes därefter Pico direkt efdterc ingreppet och under en vecka efter detta. Efter utbildning och träning använde barnmorskorna vid de respektive avdelningarna det nya vårdprotokollet och stöttade klinikerna under studien, som totalt omfattade 50 patienter som behandlades med Pico-systemet. Inga av dessa patienter fick infektioner eller krävde återbehandling.

3. Resultatet innebar en minskning från redan låga sex infektioner per 1 200 genomförda kejsarsnitt under 2011. Från början av 2012 fram till mitten av november inträffade endast en infektion bland de patienter som behandlades enligt den nya metoden.

4. “Using a Multi-Faceted Active Change Process and Infection Prevention to Reduce Post Op C-Section Infections” presenterades av Jeanette Harris, som arbetar med infektionsförebyggande åtgärder, samt Evelyn Hickson, specialist på perinatal vård, båda från MultiCare Health Systems, i samband med ”The 27th Annual Clinical Symposium on Advances in Skin & Wound Care” som genomfördes i Las Vegas, USA 20-23 oktober 2012.

För vidare information om Pico, besök www.mypico.com eller www.possiblewithpico.com,. Du kan också följa @woundcare Twitter för senaste nytt från Smith & Nephews Advanced Wound Management division.

In English

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.

- ends -

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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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