title: A Mechanomodulatory Device to Minimize Incisional Scar Formation.
abstract: OBJECTIVE
  To mechanically control the wound environment and prevent cutaneous scar formation.
  
  
  METHODS
  We subjected various material substrates to biomechanical testing to investigate their ability to modulate skin behavior. Combinations of elastomeric materials, adhesives, and strain applicators were evaluated to develop topical stress-shielding devices. Noninvasive imaging modalities were utilized to characterize anatomic site-specific differences in skin biomechanical properties in humans. The devices were tested in a validated large animal model of hypertrophic scarring. Phase I within-patient controlled clinical trials were conducted to confirm their safety and efficacy in scar reduction in patients undergoing abdominoplasty surgery.
  
  
  RESULTS
  Among the tested materials and device applicators, a polymer device was developed that effectively off-loaded high tension wounds and blocked pro-fibrotic pathways and excess scar formation in red Duroc swine. In humans, different anatomic sites exhibit unique biomechanical properties that may correlate with the propensity to form scars. In the clinical trial, utilization of this device significantly reduced incisional scar formation and improved scar appearance for up to 12 months compared with control incisions that underwent routine postoperative care.
  
  
  METHODS
  This is the first device that is able to precisely control the mechanical environment of incisional wounds and has been demonstrated in multiple clinical trials to significantly reduce scar formation after surgery.
  
  
  CONCLUSIONS
  Mechanomodulatory strategies to control the incisional wound environment can significantly reduce pathologic scarring and fibrosis after surgery.
authors: Department of Surgery, Stanford University , Stanford, California.
authors: Victor W
authors: VW
authors: Wong
authors: Neodyne Biosciences, Inc. , Menlo Park, California.
authors: Bill
authors: B
authors: Beasley
authors: Neodyne Biosciences, Inc. , Menlo Park, California.
authors: John
authors: J
authors: Zepeda
authors: Department of Materials Science and Engineering, Stanford University , Stanford, California.
authors: Reinhold H
authors: RH
authors: Dauskardt
authors: Department of Biomedical Engineering, Stanford University , Stanford, California.
authors: Paul G
authors: PG
authors: Yock
authors: Department of Surgery, Stanford University , Stanford, California.
authors: Michael T
authors: MT
authors: Longaker
authors: Department of Surgery, Stanford University , Stanford, California.
authors: Geoffrey C
authors: GC
authors: Gurtner