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

通过预防术后粘连改善剖宫产的产妇结局

• 批准号: 10821599
• 负责人: Lauren Costella
• 金额: $ 87.47万
• 依托单位: LUNA LABS USA, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-18 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10821599
• 关键词: Abdomen; Address; Adhesions; Adopted; African American; Age; Alginates; Biotechnology; Birth; Black race; Cattle; Cesarean section; Chitosan; Cicatrix; Clinical; Clinical Research; Clinical Trials; Collaborations; Confined Spaces; Contracts; Development; Diabetes Mellitus; Disparity; Education; Evaluation; Film; Formulation; Funding; Goals; Government; Gynecologic; High Risk Woman; Histopathology; Human; Hydrogels; Hypertension; Incidence; Individual; Infertility; Insurance; Investments; Legal patent; Live Birth; Maintenance; Marketing; Maternal Health; Maternal Health Services; Maternal Mortality; Measurable; Medicaid; Minority Groups; Modeling; Mothers; Mus; Myometrial; National Institute on Minority Health and Health Disparities; Not Hispanic or Latino; Operative Surgical Procedures; Oryctolagus cuniculus; Outcome; Pain; Patients; Pelvis; Phase; Polymers; Population; Postoperative Complications; Postoperative Period; Pregnancy; Prevention; Procedures; Quality of Care; Rattus; Reporting; Research Contracts; Risk; Safety; Severities; Shapes; Sodium; Solid; Source; Strategic Planning; Surface; Surgical complication; Surgical incisions; Target Populations; Technology; Testing; Time; Tissues; Uterine Rupture; Uterus; Validation; Water; Woman; Work; biomaterial compatibility; black women; clinical trial protocol; disparity reduction; experience; first-in-human; healing; improved; injured; interest; maternal morbidity; meetings; minority communities; mouse model; payment; preclinical efficacy; pregnant; prevent; programs; treatment group; uterine smooth muscle cell; wound healing

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.

抽象的 糖尿病和高血压等各种先前存在的疾病的发生率增加 围绕孕产妇医疗保健质量的系统性问题，导致了大幅增加 在少数民族社区的剖宫产率中。这些手术程序导致 孕产妇的健康结果和术后并发症，因为剖腹产增加了骨盆的可能性 粘附形成。这些粘附是不育，疼痛和增加交付时间的主要原因 随后的出生，以及在少数民族社区中对这些程序的不成比例执行（即 这些妇女接受剖宫产的可能性高33％）意味着这些影响可能会发现更多 在这些人群中经常。当前的预防广告产品很难应用于妇科 程序，无法正确解决这种严重的手术并发症。 Luna Labs的专利Aeroveil 技术是一种可喷涂水凝胶的两组分子，已证明有效减少事件 大鼠和兔模型中腹部粘附形成的严重程度。拟议的计划将重点放在 将产品从这些腹部粘附模型转变为伤口愈合和效率 妇科应用的模型，以评估该空间中产品应用的安全性和效率。 成功完成这些努力将推动技术过渡和监管的批准，以支持 与商业伙伴开始临床试验，并减少不必要的手术并发症 少数民族社区的妇女。