SBIR Phase I: BondTrue Incision and Closure Device Prototype Development

这项小企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力将是一种新型医疗设备，它可以标准化手术切口和闭合过程，通过减少伤口引流来减少手术部位感染（ssi）的发生率。伤口并发症，即持续的伤口引流，通常发生在ssi之前。患者估计有超过10万例ssi，与近100万例额外住院有关，估计每年的费用为33亿美元。最初，该项目有机会影响肥胖患者，因为肥胖和皮下脂肪已被证明是成人和儿童SSI的一个强大的危险因素和风险预测因素，该解决方案可以最初启动，以支持这一人群，约占40%的成年人和18%的青少年。该项目将研究闭合手术部位的新解决方案，其影响包括提高手术效率和改善护理。这个小企业创新研究（SBIR）第一阶段项目通过改进的、标准化的、弯曲的手术闭合解决了减少ssi的需求，该解决方案采用类似导轨的解决方案，在闭合伤口时提供均匀的皮肤张力和准确的调整。所提出的解决方案在氯丁橡胶表面的线性和圆形切口上比徒手缝合的伤口压缩性高3.25倍，在线性切口上比手工缝合的伤口跨切口闭合性降低20%。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.