Neodyne Biosciences Inc’s Embrace™ device may improve the appearance of hypertrophic and keloid scars following abdominoplasty, according to interim results from the REFINE Trial (Scar Prevention and the Clinical Effectiveness of a Novel Mechano-modulating Polymer).
Twenty-eight tummy tuck patients showed a highly significant difference between the expert blinded assessments of scar appearance for the Embrace-treated and standard-of-care-treated incision sites. All other efficacy and tolerability related parameters were in favor of the Embrace treatment, the study showed.
“The interim results of this trial demonstrate a highly significant difference between Embrace therapy versus standard of care in one of the most challenging wounds possible in terms of offloading tension, because a tummy tuck is closed under significant tension,” says study author Rod J. Rohrich, MD, a professor and chairman of the department of plastic surgery at The University of Texas Southwestern Medical Center at Dallas, in a press release. “Given the success within this wound type, there is a high probability that the Embrace device will work in lower-tension scars as well. This study offers further evidence that active compressive strain (mechano-modulation) can provide a better aesthetic outcome than current standards of care.”
Embrace Advanced Scar Therapy delivers mechano-modulation therapy to the injury site and surrounding tissues. The device includes a disposable applicator that transfers a predetermined level of strain to a single-use adhesive silicone sheet, which is then adhered over the closed scar. The Embrace device has been cleared by the FDA and is currently being finalized for initial market release in the fourth quarter of 2012.