Safety and Efficacy of TachoSil (Absorbable Fibrin Sealant Patch) Compared With Current Practice for the Prevention of Cerebrospinal Fluid Leaks in Patients Undergoing Skull Base Surgery: A Randomized Controlled Trial.

Background: Cerebrospinal fluid (CSF) leakage associated with incomplete sealing of the dura mater is a major complication of intradural procedures.

Objective: To compare the efficacy and safety of adjunctive TachoSil (Takeda Pharma A/S, Roskilde, Denmark) with current practice for the prevention of postoperative CSF leaks in patients undergoing elective skull base surgery involving dura mater closure.

Methods: Patients were intraoperatively randomized to TachoSil or current practice immediately before primary dura closure by suturing ± duraplasty.

Fibrin Sealant Patch (TachoSil) vs Oxidized Regenerated Cellulose Patch (Surgicel Original) for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection: A Randomized Controlled Trial.

Background: Local hemostatic agents are important for the control of bleeding during liver resection when standard surgical techniques are insufficient.

Study Design: This was a multicenter, randomized, open-label study to compare fibrin sealant patch (FSP; TachoSil; Takeda Pharma A/S) with oxidized regenerated cellulose gauze (ORCG; Surgicel Original; Ethicon) for the secondary treatment of local bleeding after hepatic resection in adult and pediatric patients. Primary end point was the proportion of adult patients with intraoperative hemostasis at the target bleeding site within 3 minutes of application of treatment.

Efficacy and safety of TachoSil® versus standard treatment of air leakage after pulmonary lobectomy.

Objectives: Alveolar air leakage remains a serious problem in lung surgery, being associated with increased postoperative morbidity, prolonged hospital stay and greater health-care costs. The aim of this study was to evaluate the sealing efficacy and safety of the surgical patch, TachoSil®, in lung surgery.

Methods: Patients undergoing elective pulmonary lobectomy who had grade 1 or 2 air leakage (evaluated by the water submersion test) after primary stapling and limited suturing were randomised at 12 European centres to open-label treatment with TachoSil® or standard surgical treatment (resuturing, stapling or no further treatment at the surgeons' discretion).

Hemostatic efficacy of TachoSil in liver resection compared with argon beam coagulator treatment: an open, randomized, prospective, multicenter, parallel-group trial.

Background: The aim of this trial was to confirm previous results demonstrating the efficacy and safety of a fixed combination tissue sealant versus argon beam coagulation (ABC) treatment in liver resection.

Methods: This trial was designed as an international, multicenter, randomized, controlled surgical trial with 2 parallel groups. Patients were eligible for intra-operative randomization after elective resection of ≥ 1 liver segment and primary hemostasis.

Efficacy and safety of TachoSil as haemostatic treatment versus standard suturing in kidney tumour resection: a randomised prospective study.

Objective: Elective nephron-sparing surgery (NSS) for renal cell carcinoma (RCC) has gained general acceptance as an alternative to radical nephrectomy. To achieve haemostasis without risk of local ischaemia and necrosis of kidney parenchyma after standard haemostatic suturing, we investigated TachoSil's efficacy and safety as atraumatic haemostatic treatment after kidney tumour resection.

Methods: A total of 185 patients scheduled for NSS for small, superficial kidney tumours were included in an open, randomised, prospective, multicentre, parallel-group trial.