In the largest randomized, controlled trial to date of the embrace Advanced Scar Therapy device, Neodyne Biosciences reported a highly significant improvement in scarring for patients treated with embrace versus control at 1-year follow-up.
embrace Advanced Scar Therapy actively relieves the tension surrounding a healing scar to minimize scar formation and uses technology initially developed at Stanford University and subsequently licensed to Neodyne Biosciences.
"These data further support the long-term value proposition of embrace, which has now been shown to improve results out to one year post-surgery. The differences were highly significant between embrace-treated and control-treated groups when analyzed by independent, blinded reviewers using the Visual Analog Scale [VAS]," said Geoffrey Gurtner, MD, FACS and Co-Founder of Neodyne Biosciences.
The REFINE trial enrolled patients who underwent abdominoplasty procedures, a challenging indication for scarring since the incision is closed under maximum tension. Half of each newly closed incision was selected randomly to be treated with the embrace® device. The remaining portion of the incision served as the "control" side and was treated according to the plastic surgeon’s standard of care.
-At 12 months, the mean VAS score for embrace-treated scars was significantly improved compared to control-treated scars, (difference = 0.39, 95% confidence interval [0.14, 0.66], p = 0.027).
-Both subjects and investigators found that embrace-treated scars demonstrated significant improvements in overall appearance at 12 months using the Patient and Observer Scar Assessment Scale (POSAS), (p = 0.02 and p < 0.001, respectively).
"The differences at one year between the embrace-treated and control-treated scars were highly significant, showing no regression to the mean and an extremely positive long-term benefit in scar reduction with the embrace device," said Michael Longaker, MD, FACS and Co-Founder of Neodyne Biosciences.
"Neodyne is committed to providing clinically proven technologies to both surgeons and patients looking to minimize scarring," said Bill Beasley, President of Neodyne Biosciences, "embrace® is the first scar management product of its kind, and to our knowledge, no other scar treatment is backed by the same wealth of clinical data."