Tissue loads applied by a novel medical device for closing large wounds

Closure of large soft-tissue defects following surgery or trauma constitutes substantial but common reconstructive challenges. Closing the wounds with sutures is a common solution yet involving high-tension closure. The alternative methods of closure such as skin grafting are often associated with relatively more complex surgical procedures, significant morbidity, and extended hospitalization and recovery periods. Here, we evaluate the efficacy of a tension relief system (TRS) device and compare it to surgical sutures. We employed finite element modeling and simulated three cases of (real) large wounds which were treated with TRS in reality, each located in a different organ and has different dimensions. Closure of the wounds induced peak-effective stresses on the skin that were at least an order of magnitude greater (and sometimes nearly 2 orders of magnitude greater) than when tension sutures were used with respect to the corresponding TRS data. For the tension suture simulations, the tensile stress was in the range of 415–648MPa and in the TRS simulations, it was 16–30MPa. Such large localized tissue distortions may obstruct the vasculature surrounding the wound or at the sutured skin itself, which will cause ischemia and necrosis of the skin within several hours following surgery. In addition, the substantial reduction of loads on and within the skin during large wound closure by the TRS allows surgeons to optimally employ the viscoelastic properties of the skin for primary wound closure.