Randomized, Controlled Comparison of Advanced Hemostatic Pads in Hepatic Surgical Models

Blood loss during hepatic surgery leads to poor patient outcomes. This study investigates the hemostatic efficacy of a novel sealing hemostatic pad (polyethylene glycol-coated collagen, PCC) and a fibrin sealant pad (fibrin-thrombin coated collagen, FTC) in a leporine hepatic segmentectomy and a porcine hepatic abrasion model. A segmentectomy was used to compare hemostatic success and hematoma incidence in 20 rabbits (10/group). Hepatic abrasions were used to compare hemostatic success up to 10？min after application in six pigs (42 lesions/group). In the segmentectomy model, PCC achieved 100% hemostatic success within 2？min (95% CI: 72.3% to 100%) and FTC achieved 80% hemostatic success within 3？min (49.0% to 94.3%). PCC had lower hematoma incidence at 15？min (0.0 versus 11.1%) and 24？h (20.0 versus 66.7%). In the abrasion model, PCC provided superior hemostatic success at 3 (odds ratio: 24.8, 95% CI: 8.86 to 69.2, ), 5 (66.3, 28.5 to 153.9, ), 7 (177.5, 64.4 to 489.1, ), and 10？min (777.6, 148.2 to 4078, ) leading to statistically significant less blood loss. The novel sealing hemostat provides faster and more sustained hemostasis than a fibrin sealant pad in a leporine hepatic segmentectomy and a porcine hepatic abrasion model of hepatic surgery. 1. Introduction Patients undergoing hepatic resection can experience blood loss between 700 and 1,200？mL [1] leading to a 20–40% likelihood of receiving a transfusion [2]. These high blood loss and transfusion rates are associated with increased postoperative complications [3], increased rates of relaparotomy [4], prolonged hospital inpatient stay [3], increased likelihood of tumor recurrence [5, 6], decreased time to tumor reoccurrence [7], and greater likelihood of in-hospital mortality [3, 8]. Overall, blood loss is uniformly accepted as a predictor of patient outcome following hepatic resection, where lower blood loss has improved outcomes [4, 8, 9]. Bleeding in these patients is expected as the liver synthesizes and eliminates pro- and anticoagulation proteins [10, 11]. Acute and chronic hepatic disease leads to impaired synthesis of coagulation proteins (i.e., factors V, VII, and X–XII, fibrinogen, and prothrombin), thrombocytopenia, and excessive fibrinolysis [11, 12]. As a result, several different techniques are used during dissection and transection of hepatic parenchyma to minimize tissue perfusion and damage (e.g., Pringle maneuver, portal hypotension, surgical staplers, etc.). Inevitably, these methods have a transient or incomplete effect, which require treatment with a topical hemostatic agent