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Incisions managed with PICO demonstrate significantly fewer healing complications and improved scar quality in bilateral breast reduction patients

Smith & Nephew, the business, has announced that data from an international, multicentre-study1 presented at the Sixth European Symposium of Aesthetic Surgery of the Breast, has shown significantly fewer wound healing associated with surgery, through the post-operative application of PICO Negative Pressure Wound Therapy (NPWT) system as compared to standard wound care. The study, led by of the Northwestern University Feinberg School of Medicine, Chicago, USA, analysed the effectiveness of PICO in the reduction of post-surgical .

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 (over 30) or with other risk factors, such as tobacco smoking, high blood pressure, radiotherapy, etc… This is important for , but may also have an impact on breast reconstruction and on aesthetic interventions, which are performed in a much higher number.”

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 http://www.smith-nephew.com.

Breast teated with PICO and control breast for comparison
Image courtesy of Dr. Risal Djohan – Cleveland Clinic

Source

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

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