The effectiveness of Foley catheter balloon tamponade versus expanding sponges and hemostatic granules for catastrophic penetrating groin hemorrhage with small skin defect: A comparative study in a live tissue porcine model with evaluation of a concise training program.

ABSTRACT

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.