From the Department of Surgery (S.M.V., N.A., B.L.S.B.v.d.B., T.T.C.F.v.D., R.H.), Alrijne Hospital, Leiderdorp; Trauma Research Unit, Department of Surgery (S.M.V., O.J.F.v.W., M.H.J.V., R.H.), Erasmus MC, University Medical Center Rotterdam, Rotterdam; Defense Healthcare Organization (O.J.F.v.W., T.T.C.F.v.D., R.H.), Ministry of Defense, Utrecht; and Department of Surgery (T.T.C.F.v.D., R.H.), Leiden University Medical Centre, Leiden, the Netherlands.
J Trauma Acute Care Surg. 2023 Apr 1;94(4):599-607. doi: 10.1097/TA.0000000000003836. Epub 2022 Nov 28.
Prompt bleeding control in the prehospital phase is essential to improve survival from catastrophic junctional hemorrhage. This study aimed to compare the effectiveness and practicality of Foley catheter balloon tamponade (FCBT), Celox-A, and XSTAT for the treatment of catastrophic hemorrhage from penetrating groin injuries with a small skin defect in a live-tissue porcine model. In addition, this study aimed to determine whether a training program could train military personnel in application of these advanced bleeding control adjuncts.
A standardized wound was created in 18 groins from 9 anesthetized swine. Eighteen military medics participated in the training program and performed a bleeding control procedure after randomization over the swine and test products and after transection of the femoral neurovascular bundle. Primary endpoints were bleeding control, time to bleeding control, rebleeding, blood loss, medic performance, and user product rating.
No significant differences were found in vital signs and laboratory values between the groups. In the Celox-A group, 3/6 groins achieved hemorrhage control. This was 6/6 in the XSTAT and FCBT groups. XSTAT scored best on application time, time to obtain hemorrhage control, hemorrhage control score, and practicality. No significant differences were found between groups for rebleeding, amount of blood loss, and medic performance. Military medics had a significant higher preference for XSTAT over Celox-A. This was not significant for FCBT.
All tested products proved effective in obtaining hemorrhage control. XSTAT has the highest effectivity and shortest application time for the treatment of catastrophic bleeding from nonpackable, penetrating junctional groin injuries with a small skin defect, compared with Celox-A and FCBT. XSTAT scored best on practicality. This study shows that our training curriculum can be used to train military medics with limited prior experience in the use of advanced bleeding control techniques for penetrating junctional groin injuries with small skin defect.
在院前阶段及时进行压迫性止血对于提高灾难性腹股沟交界处出血的生存率至关重要。本研究旨在比较 Foley 导管球囊填塞（FCBT）、Celox-A 和 XSTAT 在活体组织猪模型中治疗伴有小皮肤缺损的穿透性腹股沟损伤所致灾难性出血的有效性和实用性。此外，本研究旨在确定培训计划是否可以培训军事人员应用这些先进的止血辅助方法。
在 9 头麻醉猪的 18 个腹股沟处创建了一个标准化伤口。18 名军事医务人员参加了培训计划，并在对猪和测试产品进行随机分组以及切断股神经血管束后，进行了止血控制程序。主要终点是止血效果、达到止血效果的时间、再出血、失血量、医务人员的表现和产品的用户评分。
各组间生命体征和实验室值无显著差异。在 Celox-A 组，6/6 腹股沟实现了出血控制。XSTAT 和 FCBT 组均为 6/6。XSTAT 在应用时间、获得出血控制时间、出血控制评分和实用性方面得分最高。各组间再出血、失血量和医务人员表现无显著差异。军事医务人员对 XSTAT 的偏好明显高于 Celox-A，但对 FCBT 的偏好则不显著。
所有测试的产品均能有效达到止血效果。与 Celox-A 和 FCBT 相比，XSTAT 在治疗伴有小皮肤缺损的非填塞性穿透性腹股沟交界处出血方面具有最高的有效性和最短的应用时间。XSTAT 在实用性方面得分最高。本研究表明，我们的培训课程可以用于培训具有有限使用先进止血技术经验的军事医务人员，用于治疗伴有小皮肤缺损的穿透性腹股沟交界处损伤。
