Background: Hemostatic gauzes, which must be packed into wounds and compressed for several minutes, may be of limited use for noncompressible wounds in junctional anatomic locations. Rapid mechanical wound sealing is an alternative approach that seals the wound at the skin, allowing internal clot formation. We evaluate wound sealing for junctional hemorrhage control using a hemostatic clamp (iTClamp).
Methods: Severe junctional hemorrhage was induced in anesthetized immature female swine using a 5-mm femoral arteriotomy. After 30 seconds of free bleeding, animals were randomized to one of seven hemostatic interventions: no intervention (control), direct compression for 3 minutes (compression), plain gauze packing (packing), mechanical wound seal (seal), plain gauze packing + wound seal (packing + seal), plain gauze packing + compression (packing + compression), or hemostatic gauze packing (Combat Gauze) + compression (HS-packing + compression). All animals then received one 15-mL/kg bolus of Hextend, followed by lactated Ringer's solution for hypotension up to 100 mL/kg. Animals were monitored for 3 hours.
Results: Survival was similar between control (3-hour survival, 0%) and compression (0%, Kaplan-Meier survival analysis and log-rank test [KM-LR], p = 1.0) but marginally improved with packing (12.5%, KM-LR, p < 0.001). Survival improved with seal (62.5%) versus control (KM-LR, p < 0.001) and with packing + seal (100%) versus packing alone (KM-LR, p < 0.001). Survival was similar between packing + compression (87.5%), HS-packing + compression (62.5%), and packing + seal (100%) (KM-LR, p ≥ 0.05). Total hemorrhage volume was decreased for seal versus control (p < 0.001) and for packing + seal versus packing (p < 0.001). Hemorrhage was similar among packing + compression, HS-packing + compression, seal, and packing + seal (analysis of variance p ≥ 0.05). Application times (mean [SD]) were significantly faster with packing + seal (125.8 [56.2] seconds) than packing + compression (236.6 [7.2] seconds) and HS-packing + compression (223.0 [6.8] seconds) (analysis of variance, all p < 0.001).
Conclusion: In this preclinical junctional hemorrhage model, rapid wound sealing improved survival and decreased hemorrhage in both packed and unpacked wounds and performed comparably with standard-of-care hemostatic bandages. Rapidly sealing junctional wounds may be a viable alternative to wound compression.