The safety and efficacy of haemostasis with a catechol-conjugated, chitosan-based haemostatic dressing versus a chitosan-based haemostatic dressing after transfemoral approach for transcatheter arterial chemoembolization: a randomized controlled trial

PURPOSE: To compare the haemostatic efficacy (i.e. efficacy to prevent access site complications) of the InnoSEAL haemostatic pad and Clo-Sur PLUS P.A.D. after femoral arterial puncture for transcatheter arterial chemoembolization (TACE). MATERIAL AND METHODS: This randomized controlled trial compared the safety and efficacy of an InnoSEAL haemostatic pad (n = 48) and a Clo-Sur PLUS P.A.D. (n = 52) for haemostasis of arterial puncture sites after TACE with femoral arterial access using a 5-Fr sheath. Primary endpoints were incidence of major (necessitating surgery) and moderate access site complications (ASC) (necessitating blood transfusion/thrombin injection). Secondary endpoints were incidence of minor ASC (no therapy required) and time to haemostasis. RESULTS: No major or moderate ASC was seen with either device. Minor ASC (6.3% [3/48] vs. 19.2% [10/52], p = 0.075) and ecchymosis (classified as minor ASC; 4.2% [2/48] vs. 17.3% [9/52]; p = 0.053, p-value cut-off after Bonferroni correction = 0.025) were less frequently observed with the InnoSEAL haemostatic pad. The time to haemostasis did not differ significantly between the 2 devices (5.6 ± 1.0 vs. 5.3 ± 0.7 minutes; p = 0.118). Multivariable logistic regression analysis showed a lower risk of ASC with the InnoSEAL pad (adjusted OR, 0.174; 95% CI: 0.034-0.890; p = 0.036). CONCLUSIONS: No major ASC was seen with either pad, and no significant difference of minor ASC was observed between 2 pads.