Positive trial results for abdominoplasty scar therapy
Published date : 08 August 2012
Article date : 08 August 2012
Neodyne Biosciences has announced positive interim results from the REFINE Trial (Scar Prevention and the Clinical Effectiveness of a Novel Mechano-modulating Polymer,) a randomised control clinical trial designed to assess the efficacy and tolerability of the Embrace(TM) device for use in the management of closed hyper-proliferative (hypertrophic and keloid) scars. This interim analysis demonstrates the efficacy of Embrace therapy within abdominoplasty (tummy tuck) - a scar-prone surgical procedure.
The results of the first 28 patients to complete the six month assessment showed a highly significant difference between the expert blinded assessments of scar appearance for the Embrace treated as compared to the control (standard-of-care treated) incision sites. All other efficacy and tolerability related parameters were strongly positive and in favor of the Embrace treatment versus that of standard-of-care, including the Patient and Observer Scar Assessment Scales (POSAS), physician and patient preference and enthusiasm to recommend and to use in the future.
Embrace Advanced Scar Therapy delivers mechano-modulation therapy to the injury site and surrounding tissues. The device includes a simple disposable applicator that transfers a predetermined level of strain to a single use adhesive silicone sheet, which is then adhered over the closed scar. This unique mechanism of action provides a uniform compressive strain, or stress-shield around a closed scar, which can minimize collagen proliferation and formation of scar tissue. The Embrace device has been FDA Cleared (September, 2011), and is being finalised for initial market release later.
Read further details here
