The findings were presented at the Aesthetic Surgery of the Breast Symposium in Milan.
PICO, a pocket-sized negative pressure wound therapy device, is cleared for use in hospital and homecare settings in Europe, the US, Canada, Japan and Australia.
In the new prospective, randomized, intra-patient trial study, researchers analyzed the effectiveness of PICO in the reduction of post-surgical complications in 200 bilateral breast reduction patients at six centers. PICO was compared to the standard post–operative wound care procedure (surgical strips).
Breast reduction has a high frequency of postoperative complications, particularly in patients overweight or obese, where the percentage ranges from 21.6% to 35%, the study authors point out.
The primary analysis shows significantly fewer healing complications for PICO compared to standard care (p<0.004), and a 38% relative reduction in surgical dehiscence 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. Both Patient and Observer Scar Assessment Scale and Visual Analogue scale scoring systems demonstrated that PICO provided a superior quality scar (p<0.001) over standard of care at 42 and 90 days.
“The psychological impact of breast surgery is considerable, and often scarring is the primary source of dissatisfaction for 65% of the patients, says Maurizio Nava, MD, Congress president and associate professor of plastic surgery at the University of Milan in Italy, in a news release. “Data from clinical investigations into breast surgery suggest that innovative devices like PICO can effectively reduce the incidence of surgical complications and improve the scar appearance, and this is particularly important for high risk patient groups. This is important for breast reduction surgery, but may also have an impact on breast reconstruction and on aesthetic interventions.”
This study was sponsored by Smith & Nephew.