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International study shows incisions managed with unique PICO◊ NPWT System demonstrated significantly fewer healing complications and improved scar quality in bilateral breast reduction patients

17th December 2014

Smith & Nephew (LSE: SN, NYSE: SNN), the global medical technology business, today announces that data from an international, multicentre-study1 presented at the Sixth European Symposium of Aesthetic Surgery of the Breast (Milan, December 10-13, 2014), has shown significantly fewer wound healing complications associated with breast reduction surgery, through the post-operative application of PICO Negative Pressure Wound Therapy (NPWT) system as compared to standard wound care. The study, led by Dr Robert Galiano of the Northwestern University Feinberg School of Medicine, Chicago, USA, analysed the effectiveness of PICO in the reduction of  post-surgical complications.

200 bilateral breast reduction patients were observed across six leading centres in USA, Europe and South Africa. For each patient PICO was used as an incision management system and compared to the standard post–operative wound care procedure (surgical strips). The primary analysis shows significantly fewer overall healing complications for PICO compared to standard care (p<0.004), and a 38% relative reduction in surgical dehiscence (a surgical complication in which the wound ruptures along the surgical suture line) from 26.4% to 16.2% (p<0.033).

Scar Quality Improved

The study also evaluated the scar quality at 42 and 90 days post surgery. PICO showed significantly better scar quality at each time point (p<0.001). Both POSAS (Patient and Observer Scar Assessment Scale), and VAS (Visual Analogue scale) scoring systems demonstrated that PICO provided a superior quality scar over standard of care at days 42 and 90 after surgery.

Presenting the study findings at Aesthetic Surgery of the Breast, Dr. Risal Djohan, of the Cleveland Clinic, Ohio, USA, said, “This surgical procedure has a relatively high frequency of postoperative complications, particularly in patients overweight or obese, where the percentage ranges from 21.6% to 35%2-5. The study data also suggests that the incidence of delayed healing and dehiscence increases with the weight of the tissue removed. For a patient group with high expectations6, PICO presents surgeons with a real opportunity to reduce surgical incision complications and improve the aesthetic outcome.”

Dr. Maurizio Nava, congress president and associated professor of Plastic Surgery at the University of Milan, says ‘The psychological impact of breast surgery is considerable and often scarring is the primary source of dissatisfaction for 65% of the patients7. Data from clinical investigations developed in different surgical areas, and now also in breast surgery, are suggesting that the use of innovative devices like PICO, can effectively reduce the incidence of surgical complications and improve the scar appearance, and this is particularly important for patients with high Body Mass Index (>30) or with other risk factors, such as tobacco smoking, high blood pressure, radiotherapy, etc….. This is important for breast reduction surgery, but may also have an impact on breast reconstruction and on aesthetic interventions, which are performed in a much higher number.”

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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. Click here for more information about the PICO system and the NPWT portfolio of products from Smith & Nephew.

 

Enquiries

Media

For all enquiries, including interview requests, please contact

Beth Lowes at ROAD Communications: +44 20 8995 5832 or +44 7712702385 beth@ROADCommunications.co.uk

 

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.

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References

1Galiano 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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Video

Interview with Dr. R. Djohan and Dr. Maurizio Nava on the PICO clinical study

PICO Dr Djohan MD

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