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

December 10, 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

Media

Dave Snyder
[phone]
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.

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