Rodriguez Maria I, Jensen Jeffrey T, Gregory Kenton, Bullard Mary, Longo Paul, Heidel Jerry, Edelman Alison
Section of Family Planning, Department of Obstetrics and Gynecology, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR, 97239, USA.
Center for Regenerative Medicine, Oregon Health & Science University RevMedx Inc, Wilsonville, USA.
BMC Pregnancy Childbirth. 2017 Jun 13;17(1):187. doi: 10.1186/s12884-017-1373-x.
Although uterine tamponade is an effective treatment for postpartum hemorrhage (PPH), current methods have key limitations in their use, particularly in low resource settings. The XStat™ Mini Sponge Dressing (MSD) is approved for the management of non-compressible wounds in the battlefield/trauma setting. The MSD applies highly compressed medical sponges capable of stopping high-flow arterial bleeding within seconds. The objective of our study was to adopt the MSD for use in managing PPH.
We performed desktop testing using a uterine model with pressure sensors to compare key design elements of the obstetrical prototype MSD (fundal pressure achieved, reduction in fluid loss, time to deploy, and time to remove) with alternativetechniques (uterine packing, balloon tamponade). To evaluate safety, we delivered the fetus of pregnant ewes by cesarean section and used the prototype to deliver the MSD into one uterine horn, and closed the hysterotomy. We followed the clinical recovery of animals (n = 3) over 24 h, and then removed the reproductive tract for histologic evaluation. To evaluate late effects, we surgically removed the MSDs after 24 h, and followed the clinical recovery of animals (n = 6) for an additional seven days before tissue removal.
The obstetrical prototype has a long tapered delivery system designed to be deployed during vaginal examination, and administers three times the volume of the approved MSD trauma bandage. The MSD are deployed within a mesh bag to facilitate removal by vaginaltraction. On desktop testing, the MSD resulted in the highest average fundal pressure (113 mmHg), followed by the MSD bag device (85.8 mmHg), gauze packing (15.5 mmHg), and the uterine balloon (8.2 mmHg). The MSD bag test group achieved the largest fluid flow reduction of -74%, followed by gauze packing (-55%), MSD (-35%), and uterine balloon (-19%). Animal testing demonstrated good uterine fill with no evidence of adverse clinical recovery, uterine trauma or infection at 24 h, or up to 7 days following device removal.
We adapted a highly effective trauma dressing and applicator for use in the treatment of severe PPH. Preliminary desktop and animal testing provide a basis for initial clinical trials in women.
尽管子宫压迫法是治疗产后出血（PPH）的有效方法，但目前的方法在使用上存在关键局限性，尤其是在资源匮乏地区。XStat™迷你海绵敷料（MSD）已被批准用于战场/创伤环境中不可压缩伤口的处理。MSD可应用高度压缩的医用海绵，能够在数秒内止住高流量动脉出血。我们研究的目的是将MSD应用于PPH的处理。
我们使用带有压力传感器的子宫模型进行桌面测试，以比较产科原型MSD的关键设计要素（达到的宫底压力、失液减少情况、部署时间和移除时间）与其他技术（子宫填塞、球囊压迫）。为评估安全性，我们通过剖宫产分娩怀孕母羊的胎儿，并使用原型将MSD送入一个子宫角，然后关闭子宫切口。我们在24小时内跟踪动物（n = 3）的临床恢复情况，然后取出生殖道进行组织学评估。为评估后期影响，我们在24小时后手术取出MSD，并在取出组织前额外7天跟踪动物（n = 6）的临床恢复情况。
产科原型有一个长的锥形输送系统，设计用于在阴道检查期间部署，并输送三倍于已批准的MSD创伤绷带体积的物质。MSD被部署在一个网袋内，以便通过阴道牵引便于取出。在桌面测试中，MSD导致平均宫底压力最高（113 mmHg），其次是MSD袋装置（85.8 mmHg）、纱布填塞（15.5 mmHg）和子宫球囊（8.2 mmHg）。MSD袋测试组实现了最大的液体流量减少，为-74%，其次是纱布填塞（-55%）、MSD（-35%）和子宫球囊（-19%）。动物测试表明子宫填充良好，在24小时或取出装置后长达7天内没有不良临床恢复、子宫创伤或感染的证据。
我们改编了一种高效的创伤敷料和施药器用于严重PPH的治疗。初步的桌面和动物测试为在女性中进行初步临床试验提供了基础。
