SBIR Phase I: BondTrue Incision and Closure Device Prototype Development

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will be a novel medical device that standardizes the process of surgical incision and closure, which could decrease the prevalence of surgical site infections (SSIs) through reducing wound drainage. Wound complications, namely persistent wound drainage, typically precede SSIs. Patients suffer from an estimated 100,000+ SSIs, associated with nearly 1 million additional inpatient-stays and estimated annual cost of $3.3 billion. Initially, the project has the opportunity to impact obese patients, as obesity and subcutaneous fat have shown to be a strong risk factor and risk predictor of SSI in both adults and children, this solution can be launched initially to support this population, representing roughly 40% of adults and 18% in youths. This project will investigate a new solution to close surgical sites, with impacts including improved surgical efficiency and improved care. This Small Business Innovation Research (SBIR) Phase I project addresses the need for reducing SSIs with improved, standardized, everted surgical closure with a guiderail-like solution providing uniform skin tension and accurate realignment when closing a wound. The proposed solution will produce 3.25x more wound compression than freehand closure in both linear and rounded incisions on a neoprene surface, with 20% reduction in trans-incision closure variability over hand-stapled wounds in linear incisions.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.