A novel tamponade agent for management of post partum hemorrhage: adaptation of the Xstat mini-sponge applicator for obstetric use

Abstract

BackgroundAlthough 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.MethodsWe 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.ResultsThe 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.ConclusionWe 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.Electronic supplementary materialThe online version of this article (doi:10.1186/s12884-017-1373-x) contains supplementary material, which is available to authorized users.

Profile of the Jada® System: the vacuum-induced hemorrhage control device for treating abnormal postpartum uterine bleeding and postpartum hemorrhage

“…The compressed sponges expand while absorbing blood and exerting uniform pressure on bleeding sites. The device's sponges conform to the shape of the uterine cavity and apply pressure for up to 24 h. Originally developed for combat settings, this device was redesigned with an obstetric applicator designed to be deployed vaginally, with the tip placed transcervically in the lower uterine segment [16].…”

Management of Postpartum Hemorrhage With a Mini-Sponge Tamponade Device

“… 11 In a bleeding wound, the mini-sponges rapidly absorb blood, expand, and then exert outward pressure for up to 24 hours. 12 The mini-sponges are distinct from routine laparotomy sponges, which, when saturated, become smaller in size. The effect is not due to a hemostatic agent, but simply holding and maintaining pressure.…”

“…The effect is not due to a hemostatic agent, but simply holding and maintaining pressure. 8 , 12 The types of injuries treated in trauma settings include penetrating injuries from shrapnel, gunshots, or motor vehicle accidents. Deployment in these settings is rapid and reliable and provides a high degree of hemorrhage control.…”

Emerging approaches to pre-hospital hemorrhage control: a narrative review

“…XSTAT was used in 10 patients with penetrating trauma and hemorrhage was completely stopped on initial deployment in 9 out of 10 cases. Additionally, the use of XSTAT has also been described in non-traumatic hemorrhage, notably in the field of obstetrics as a tamponade agent for postpartum hemorrhage (41). The efficacy of XSTAT has been tested in standard swine models of lethal junctional hemorrhage, including both femoral and subclavian hemorrhages.…”