Improving Maternal Outcomes of Cesarean Delivery with the Prevention of Postoperative Adhesions

摘要 糖尿病和高血压等各种既往疾病的发病率增加，与 围绕提供的孕产妇保健质量的系统性问题导致显著增加 在少数族裔社区的剖腹产率。这些外科手术造成了 产妇健康结局和术后并发症，因为剖腹产增加了盆腔的可能性 粘连形成。这些粘连是导致不孕不育、疼痛和分娩时间延长的主要原因 随后的生育，以及少数族裔社区对这些程序的过度管理(即 这些妇女接受剖腹产的可能性要高出33%)，这意味着这些影响可能会出现更多 通常发生在这些人群中。目前预防粘连的产品很难在妇科应用 手术和未能妥善处理这一严重的手术并发症。露娜实验室的专利AeroVeil 技术，一种双组分可喷雾水凝胶，已被证明在减少发病率方面有效 以及大鼠和兔模型腹壁粘连的严重程度。拟议的计划将重点放在 将产品应用从这些腹部粘连模型过渡到伤口愈合和疗效 妇科应用模型，以评估该领域产品应用的安全性和有效性。 这些努力的成功完成将推动技术过渡和监管批准，以支持 与商业合作伙伴一起启动临床试验，减少不必要的手术并发症 少数族裔社区的妇女。

ABSTRACT An increased incidence of various pre-existing conditions like diabetes and hypertension, combined with systemic issues surrounding the quality of maternal health care provided, has resulted in a significant increase in the cesarean delivery rate in minority communities. These surgical procedures contribute to disparities in maternal health outcomes and postoperative complications, as C-sections increase the likelihood of pelvic adhesion formation. These adhesions are a leading cause of infertility, pain, and increased delivery time for subsequent births, and the disproportionate administration of these procedures in minority communities (i.e. these women are 33% more likely to undergo cesarean delivery) means these repercussions may be found more frequently in these populations. Current products for adhesion prevention are difficult to apply in gynecologic procedures and fail to properly address this severe surgical complication. Luna Labs’ patented AeroVeil technology, a two-component sprayable hydrogel, has been demonstrated effective in decreasing the incidence and severity of abdominal adhesion formation in rat and rabbit models. The proposed program will focus on transitioning product application from these abdominal adhesion models into wound healing and efficacy models of gynecologic applications to evaluate the safety and efficacy of product application in this space. Successful completion of these efforts will drive technology transition and regulatory approval to support the initiation of clinical trials with a commercial partner and reduce the needless surgical complications suffered by women in minority communities.