Objective: To mechanically control the wound environment and prevent cutaneous scar formation. Approach: 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 profibrotic 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. Innovation: 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. Conclusion: Mechanomodulatory strategies to control the incisional wound environment can significantly reduce pathologic scarring and fibrosis after surgery.
INTRODUCTIONWound healing proceeds through overlapping stages of inflammation, proliferation, and remodeling.1 All wounds heal with some degree of scar formation, but the mechanisms that govern whether the result will be a fine thin scar, a prominent hypertrophic scar, or a tumor-like keloid remain unclear.2,3 It is estimated that more than 230 million major surgical procedures are performed around the world each year, all of which result in cutaneous wounds which heal with scars. 4 In addition, fibrotic complications after injury can cause considerable dysfunction and disfigurement, costing more than $4 billion yearly in healthcare costs in the United States alone.5 Modern multimodality regimens have produced inconsistent outcomes, and recombinant cytokinebased strategies have failed to prevent scar formation in phase III clinical trials (www.renovo.com). 6 The current challenge for researchers and health care providers is to develop highly effective approaches that combat this significant biomedical problem.The role of mechanical force in wound healing was observed by anatomists and surgeons more than a century ago.7 Subsequent clinical observations and reports have substantiated the importance of tension in scar formation after injury. For example, sternotomy wounds develop greater fibrosis in the lower half of the incision that is subj...