New Condom: Feasibility Study

描述(申请人提供)：这笔赠款的主要目标是改进和测试舒适避孕套的原型(Tm)：一种由硅胶制成的新避孕套，这种材料可能提供更好的感觉，并且比乳胶或塑料更不容易破裂。舒适避孕套将采用几项技术创新，包括：1)坚固、厚实的材料，摸起来像人体组织，创造感觉，而不是充当过滤器；2)宽松的贴合，更舒适；3)离散的阴囊固定带，减少滑脱的可能性；4)高度可伸缩的材料，更适合和舒适。具体的研究目标有五个：1.采用液体注射成型技术，以硅胶为原料，制作了三种舒适避孕套原型。2.确认舒适避孕套(TM)中使用的VI类医用硅胶在制造过程后仍保持生物相容性。完成的避孕套将接受细胞毒性、致敏性、刺激性和全身毒性的实验室测试。所有三款原型机都将接受测试。3.通过测量拉伸性能、泄漏量、渗透率、空爆量和空爆压力来评估舒适避孕套(Tm)的结构完整性。所有三款原型机都将接受测试。4.比较三种舒适避孕套(Tm)原型的安全性、可接受性和性能。一项名为“可行性和设计性”的研究将对十对异性伴侣进行。每对夫妇将使用六个避孕套(每个原型两个)，对每个避孕套的各种主观特征进行评级，并报告他们可能遇到的任何破损、滑脱或不良事件。5.比较最舒适避孕套原型(Tm)和市售男用乳胶避孕套的安全性、可接受性和性能。将对36对夫妇进行“表现和可接受性”研究。每对夫妇将使用三个舒适避孕套(TM)和三个乳胶避孕套，对每个避孕套的各种主观特征进行评级，并报告他们可能遇到的任何破裂、滑脱或不良事件。对于性生活活跃的夫妇来说，正确和始终如一地使用避孕套是降低艾滋病毒和其他性传播感染(STI)风险的最有效方法。不幸的是，许多人认为乳胶避孕套是不可接受的。开发新的和改进的避孕套是防治艾滋病毒/艾滋病危机的一个关键组成部分。

DESCRIPTION (provided by applicant): The primary objective of this grant is to refine and test a prototype of the Comfort Condom(tm): a new condom made from silicone, a material that may offer better sensation and be less prone to breakage than latex or plastic. The Comfort Condom will feature several technological innovations, including: 1) strong, heavy- gauge material that feels like human tissue, creating sensation instead of acting as a filter to it, 2) a loose fit for greater comfort, 3) a discrete scrotal retention band to reduce the likelihood of slippage, and 4) highly stretchable material for better fit and comfort. There are five specific aims: 1. Fabricate three prototypes of the Comfort Condom(tm) from silicone using liquid injection molding. 2. Confirm that the Class VI medical grade silicone used in the Comfort Condom(tm) remains biocompatible after the manufacturing process. The completed condoms will undergo laboratory testing for cytotoxicity, sensitization, irritation, and systemic toxicity. All three prototypes will be tested. 3. Assess the structural integrity of the Comfort Condom(tm) by measuring tensile properties, leakage, permeability, airburst volume, and airburst pressure. All three prototypes will be tested. 4. Compare the safety, acceptability, and performance of the three Comfort Condom(tm) prototypes. A "Feasibility and Design" study will be conducted with ten heterosexual couples. Each couple will use six condoms (two of each prototype), rate various subjective features of each condom, and report on any breakage, slippage, or adverse events they may experience. 5. Compare the safety, acceptability, and performance of the best Comfort Condom(tm) prototype with a commercial male latex condom. A "Performance and Acceptability" study will be conducted with thirty-six couples. Each couple will use three Comfort Condoms(tm) and three latex condoms, rate various subjective features of each condom, and report on any breakage, slippage, or adverse events they may experience. For sexually active couples, condoms used correctly and consistently are the most effective method available to reduce the risk of transmitting HIV and other sexually transmitted infections (STI). Unfortunately, many individuals find latex condoms unacceptable. The development of new and improved condoms is a key component in combating the HIV/AIDS crisis.