Global

‡ In these countries please contact our distributor

RCT demonstrates that breast surgery incisions managed with PICO◊ have significantly improved scar quality compared with standard care

10 December 2018

Smith & Nephew (NYSE:SNN; LSE:SN), the global medical technology business, today welcomes the publication of a new randomised controlled trial (RCT) demonstrating the effectiveness of PICO™ Single Use Negative Pressure Wound Therapy System (sNPWT) in reducing healing complications and improving the quality of scars following bilateral breast reduction mammoplasty.1

The prospective RCT, published in the journal Aesthetic Plastic Surgery, evaluated patients who underwent a bilateral breast reduction mammoplasty and demonstrated a significant reduction in wound healing complications within 21 days of surgery when treated with PICO versus standard care.

Quality of scarring was assessed post operatively at days 42, 90, 180 and 365 to track the progress of scar healing from start to finish. Significant improvements in quality of scarring at days 42 and 90 (p<0.05) were demonstrated using two comprehensive scoring scales – the visual analogue scale (VAS) and the patient scales and observer scale (POSAS). The scales were completed by both patients and healthcare professionals and involve the scoring of a number of parameters such as pigmentation, itching and patient comfort to rank the aesthetic appearance and overall quality of the scars.

In addition to the benefits in scarring quality, healthcare professionals involved in the study found the PICO wound dressing easy to use and patients gave it a high score for comfort. Furthermore, healthcare professionals and patients reported that PICO did not cause much pain or irritation upon removal.1

Dr Volkan Tanaydin, lead author of this study, said “Scarring has been found to be the number one cause of dissatisfaction regarding the aesthetic outcome of the breasts postoperatively.2 Within the 100,000 patients operated on in the US per year,3 up to 15% of inframammary scars are reported to be thick, itchy or uncomfortable following inferior pedicle breast reduction,1,4 with 13.5% of the scars deemed completely unacceptable.5 As well as suffering from musculoskeletal fatigue and pain, many patients experience side effects such as skin rashes due to excessive moisture and heat beneath the breasts.6

Professor Van Der Hulst, of Maastricht University Hospital and one of the authors, said, ‘Data received on the surgical outcomes of patients with various contraindications to healing can assist in developing new preventative measures to adverse scar formation. This RCT has indicated a significant improvement in the aesthetic appearance and quality of scarring [at days 42 and 90] using PICO when applied prophylactically as opposed to standard care.”

The results reported in this study are part of a larger multicentre study by Galiano et al. This RCT involving 200 patients undergoing bilateral reduction mammoplasties showed a 38% relative reduction in incidence of post-surgical dehiscence with PICO compared with standard dressings (p<0.001).7

Learn more about the study

Learn more about PICO and breast surgery incisions

 

Enquiries

Media

Dave Snyder
+1 (978) 749-1440
Smith & Nephew

 

References

  1. Tanaydin V, Beugels J, Andriessen A, Sawor JH, van der Hulst RRWJ. Randomized controlled study comparing disposable negative-pressure wound therapy with standard care in bilateral breast reduction mammoplasty evaluating surgical site complications and scar quality. Aesthetic Plast Surg. 2018;42(4):927-935.
  2. Brown AP, Hill C, Khan K. Outcome of reduction mammoplasty–a patients' perspective. Br J Plast Surg. 2000;53(7):584-587.
  3. Ambaye AB, Goodwin AJ, MacLennan SE, Naud S, Weaver DL. Recommendations for pathologic evaluation of reduction mammoplasty specimens: a prospective study with systematic tissue sampling. Arch Pathol Lab Med. 2017;141(11):1523-1528.
  4. Eggert E, Schuss R, Edsander-Nord A. Clinical outcome, quality of life, patients' satisfaction, and aesthetic results, after reduction mammaplasty. Scand J Plast Reconstr Surg Hand Surg. 2009;43(4):201-206.
  5. Makboul M, Abdelhamid M, Al-Attar G. Long term follow up and patient satisfaction after reduction mammoplasty: superomedial versusi pedicle. World J Plast Surg. 2017;6(1):82-87.
  6. Brown DM, Young VL. Reduction mammoplasty for macromastia. Aesthetic Plast Surg. 1993;17(3):211-23.
  7. Galiano RD, Hudson D, Shin J, et al. Incisional negative pressure wound therapy for prevention of wound healing complications following reduction mammaplasty. Plast Reconstr Surg Glob Open. 2018;6(1):e1560.

 

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 15,000 employees and a presence in more than 100 countries. Annual sales in 2017 were almost $4.8 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

 

For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on www.Facebook.com

To learn more about how we can help you get CLOSER TO ZERO™ surgical site complications, please visit www.closertozero.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, payers 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 or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational 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.

 

Trademark of Smith & Nephew.  Certain marks registered US Patent and Trademark Office.16686