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Internationaal onderzoek toont aan dat incisies behandeld met het unieke PICO◊ Negatieve Druk Systeem significant minder wondcomplicaties en een betere litteken kwaliteit geven bij patiënten met bilaterale borstreductie.

Smith & Nephew (LSE: SN, NYSE: SNN), wereldwijd medisch technologiebedrijf, kondigt vandaag aan dat de gegevens van een internationaal multicenter-onderzoek1 gepresenteerd op het Symposium van Esthetische Borstchirurgie (Milaan, 10-13 december , 2014), heeft aangetoond dat significant minder wondhelingscomplicaties geassocieerd met borstreductie voorkomen bij de post-operatieve toepassing van PICO Negatieve Druk Therapie. De studie, geleid door Dr Robert Galiano van de Northwestern University Feinberg School of Medicine, Chicago, USA, analyseerde de effectiviteit van PICO in de vermindering van post-operatieve complicaties.

200 bilaterale borstreductie-patiënten werden in zes toonaangevende centra gevolgd. PICO werd gebruikt als incisie management-systeem en vergeleken met de standaard postoperatieve wondverzorgingsprocedure (chirurgische hechtstrips). De eerste analyse geeft significant minder helingscomplicaties met PICO vergeleken met de standaardbehandeling (p =0,004), en 38% vermindering van chirurgische dehiscentie van 26.4% naar 16.2 % (p <0.001).

 

Littekenkwaliteit verbetering

De studie evalueerde ook het littekenkwaliteit op 42 en 90 dagen na de operatie. Beide, POSAS (Patiënt and Observer Scar Assessment Scale) en VAS (Visual Analogue Scale) scoring systemen, toonden een superieure litteken kwaliteit met PICO dan met de standaardzorg (p <0,001) op dag 42 en 90 na chirurgie.

Bij de presentatie van de bevindingen van deze studie op het Esthetische Borstchirurgie - symposium, zei Dr. Risal Djohan, van de Cleveland Clinic, Ohio, USA: "Deze chirurgische procedure heeft een relatief hoge frequentie van postoperatieve complicaties, vooral bij patiënten met overgewicht of obesitas, waar het percentage varieert van 21,6% tot 35% 2-5. Voor een patiëntengroep met een hoge verwachting6, biedt PICO chirurgen een reële kans om chirurgische incisie-complicaties te verminderen en het esthetisch resultaat te verbeteren. "

Dr. Maurizio Nava, voorzitter van het symposium en geassocieerd hoogleraar plastische chirurgie aan de Universiteit van Milaan, zegt 'De psychologische impact van borstoperatie is aanzienlijk en vaak zijn littekens de eerste bron van ontevredenheid voor 65% van de patients7. Gegevens uit klinisch onderzoek in borstoperaties suggereren dat innovatieve apparaten zoals PICO de incidentie van chirurgische complicaties kunnen verminderen en littekenvorming verbeteren, en dit is vooral van belang bij hoog-risico patiënten. Dit is belangrijk voor borstreductie-chirurgie, maar kan ook een impact hebben op borstreconstructie en op esthetische interventies.'

- Einde -


Voor vragen met inbegrip van volledige referenties, interviewverzoeken en beelden, neem dan contact op met

Rachel Cunningham: +44 20 8995 5832 of +44 7837209143 / rachel@ROADCommunications.co.uk


Background Information


Background facts

Breast surgery incidence

  • Nearly 3.5 million aesthetic breast operations were performed in 20138
  • 37% of women who are diagnosed with breast cancer will have a mastectomy9

SSI risk: 

  • SSI risk is 4 times higher following a mastectomy, compared to cosmetic breast surgery10
  • Post-operative complications lead to prolonged hospital stay & increased hospital costs9
  • Patients with a BMI of 35 or more were twice as likely to develop an SSI9

Psychological impact:

  • 65% of aesthetic breast surgery patients said they were dissatisfied with scaring7


The Study

A prospective, randomized, intra-patient, comparative, open, multi-centre study to evaluate the efficacy of a single use Negative Pressure Wound Therapy (NPWT) system* on the prevention of post-surgical incision healing complications in patients undergoing bilateral breast reduction surgery. This study was sponsored by Smith & Nephew. NCT01640366 http://clinicaltrials.gov/ct2/show/NCT01640366

Authors and centres involved:

  • Dr Robert Galiano, Dr Thomas Mustoe, Dr Jing Liu and Katherine Anne Piserchia: Northwestern University, Feinberg School of Medicine, Chicago, IL, USA
  • Dr Risal Djohan, Margo Rhia: Cleveland Clinic, Cleveland OH, USA
  • Dr Joseph H Shin, Dr Zachary Farris, Dr Teresa Benequista, Roger Swayze: Montefiore Medical Centre, Albert Einstein School of Medicine, Bronx, NY, USA
  • Professor Donald Hudson, Dr Kevin Adams: University of Cape Town, Cape Town, South Africa
  • Professor René Van der Hulst, Dr Jip Beugels, Dr Volkan Tanaydin, Dr John Sawor: Maastricht University Hospital, Maastricht, Netherlands and Viecuri Medical Center, Venlo, Netherlands
  • Professor Franck Duteille, Yann Donnio, Patricia Yego: CHU de Nantes – Hôtel Dieu, University of Nantes, Nantes, France


About PICO

PICO is cleared for use in hospital and homecare settings in Europe, US, Canada, Japan and Australia. For more information about the PICO system and the NPWT portfolio of products from Smith & Nephew, please visit www.smith-nephew.com. 
 

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 14,000 employees and a presence in more than 90 countries. Annual sales in 2013 were more than $4.3 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).

For more information about Smith & Nephew, please visit our corporate website www.smith-nephew.com, follow @SmithNephew plc on Twitter or visit SmithNephew plc on Facebook.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, payors 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; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; strategic actions, including acquisitions and dispositions and our success in integrating acquired businesses; and numerous other matters that affect us or our markets, including those of a political, economic, business or competitive 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.

◊ à Trademark of Smith & Nephew. Registered US Patent and Trademark Office. © Smith & Nephew December 2014 55480

References

  1. Galiano R, Djohan R, Shin J, Hudson D, Van der Hulst, Beugels J, Duteille F, Huddleston E, Cockwill J, Megginson S The effects of a single use canister-free Negative Pressure Wound Therapy (NPWT) System* on the prevention of postsurgical wound complications in patients undergoing bilateral breast reduction surgery. Presented at the 30th Annual Scientific Meeting of the British Association of Aesthetic Plastic Surgeons, London 25/26 September 2014).
  2. Baldwin CJ, Kelly EJ, Batchelor AG. J. The variation in breast density and its relationship to delayed wound healing: a 3 prospective study of 40 reduction mammoplasties. Plast Reconstr Aesthet Surg. 2010 Apr;63(4):663-5.
  3. Setälä L, Papp A, Joukainen S, Martikainen R, Berg L, Mustonen P, Härmä M. Obesity and complications in breast reduction surgery: are restrictions justified? J Plast Reconstr Aesthet Surg. 2009 Feb;62(2):195-9. Epub 2007 Nov 26.
  4. Henry SL(1), Crawford JL, Puckett CL. Risk factors and complications in reduction mammaplasty: novel associations and preoperative assessment. Plast Reconstr Surg. 2009 Oct;124(4):1040-6. doi: 10.1097/PRS.0b013e3181b45410.
  5. Cunningham BL, Gear AJ, Kerrigan CL, Collins ED. Analysis of breast reduction complications derived from the BRAVO study. Plast Reconstr Surg. 2005 May;115(6):1597-604.
  6. Harcourt, D., & Rumsey, N. (2001). Psychological aspects of breast reconstruction: a review of the literature. Journal of advanced nursing, 35(4), 477-487.
  7. White, C. P., Khoee, H. F., Kattan, A. E., Farrokhyar, F., & Hynes, N. M. (2013). Breast Reduction Scars A Prospective Survey of Patient Preferences. Aesthet Surg J. 2013 Aug 1;33(6):817-21
  8. International Survey on Aesthetic/Cosmetic: Procedures Performed in 2013. International Society of Aesthetic Plastic Surgery. http://www.isaps.org/Media/Default/global-statistics/2014%20ISAPS%20Global%20Stat%20Results.pdf
  9. Davis, G. B., Peric, M., Chan, L. S., Wong, A. K., & Sener, S. F. 2013. Identifying risk factors for surgical site infections in mastectomy patients using the NSQIP database. The American Journal of Surgery, 2013 205(2) 194–199
  10. Olsen, M. A., Lefta, M., Dietz, J. R., Brandt, K. E., Aft, R., Matthews, R., & Fraser, V. J. 2008. Risk factors for surgical site infection after major breast operation. J Am Coll Surg 2008;207:326–335

Press pack

ZIP file (2.0MB) containing:

- Press release (with translations in Spanish, French, Italian, Dutch and Portuguese)
- PICO product images
- Related article "Karlakki et al (2013) Incisional NPWT review BJR"
- Infographic

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PICO

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