A 2020 meta-analysis compared the efficacy and safety of fibrin sealants for achieving hemostasis in peripheral vascular surgery at clotting times of 1 minute (1C) and 2 minutes (2C). A total of 5 trials (N= 693) were included for analysis. Compared to manual compression, significant improvements in hemostasis by 4 minutes after treatment application was found with Vistaseal 2C (relative risk [RR] 2.67, 95% credible interval [CrI] 2.13 to 3.34), Vistaseal 1C (RR 2.00, 95% CrI 1.45 to 2.65), and Tisseel 2C (RR 1.99, 95% CrI 1.48 to 2.60). Tisseel 1C was not found to be significantly different in achieving hemostasis 4 minutes after application (RR 1.40, 95% CrI 0.70 to 2.33). Among fibrin sealants, Vistaseal 2C was associated with a significantly higher probability of achieving hemostasis at 4 minutes after application than Vistaseal 1C (RR 1.33, 95% CrI 1.02 to 1.82), Tisseel 2C (RR 1.34, 95% CrI 1.05 to 1.77), and Tisseel 1C (RR 1.90, 95% CrI 1.18 to 3.74). For achieving hemostasis by 10 minutes, Evicel 1C and Vistaseal 2C had the highest probabilities. Similar to the primary analysis, all fibrin sealants, except Tisseel 1C, significantly improved the probability of achieving hemostasis at 10 minutes after application compared with manual compression. Vistaseal 2C was associated with a significantly higher probability of achieving hemostasis at 10 minutes after application than Tisseel 2C (RR 1.16, 95% CrI 1.02 to 1.35) and Tisseel 1C (RR 1.23, 95% CrI 1.01 to 1.76). This network meta-analysis is limited by the lack of direct comparative evidence included. [1]
A 2018 review reported on the use of TachoSil® fibrin sealant patch as dural sealant in patients undergoing spinal intradural tumor surgery. Data were reported on 35 patients (age 58.14 ± 15.56 years, follow-up 23.20 ± 9.76 months). Functional status was assessed preoperatively and at latest follow-up using Modified McCormick Scale (MMS). The spinal segments operated on included cervical (3 cases, 8.57%), thoracic (13, 37.14%), lumbar (14, 40%), cervico-thoracic (2, 5.71%), and thoraco-lumbar (3, 8.57%). Preoperatively, 18 patients (51.42%) were classified as MMS grade I or II and 17 (48.57%) were grade III, IV, or V. At follow-up, an improvement in MMS was observed in 23 patients (65.71%) and a stable functional status in 12 patients (34.28%). No product-related adverse reactions were observed. The authors concluded TachoSil® after dural closure is safe and effective for intradural spinal tumors. [2]
A 2017 review aimed to summarize the current efficacy and safety literature of fibrin sealants in dura sealing and the prevention/treatment of cerebrospinal fluid leaks. A total of 33 articles from 32 studies (N= 2,935) enrolling patients who were exposed to fibrin sealant were included; 3 were randomized controlled trials (RCTs) and the remaining were prospective cohort analyses, case controlled studies, and prospective or retrospective case series. One randomized controlled trial (N= 89) found a greater rate of intraoperative watertight dura closure in the fibrin sealant group compared to the control group (92.1% vs. 38%; p <0.001); however, post-operative cerebrospinal fluid leakage occurred more often in the fibrin sealant group than the control group (6.7% vs. 2%; p > 0.05), but this was not significant. The other two RCTs included in this review were of low evidence that were not powered to demonstrate a significant advantage of fibrin sealant. The first of these RCTs (N= 62) found 78% of patients to have postoperative CSF leaks in the fibrin sealant group compared to 74% of patients in the standard of care alone (dura mater closed with sutures and patches) group. The second RCT did not observe any CSF leakage postoperatively in any study patients; no adverse events or complications were reported. The authors concluded that evidence from a single RCT indicates fibrin sealants provided a higher rate of intraoperative watertight closure of the dura suture line than control; however, there is a need for more well-designed prospective observational trials assessing the safety and efficacy of fibrin sealants. [3]
A 2019 meta-analysis by Kinaci et al. investigated the efficacy of sealants in preventing postoperative CSF leakage in spine surgery. Among 2,542 included cases of intended or unintended durotomy, sealant was applied in 2,193 cases (86.3%), whereas 349 cases (13.7%) underwent suture repair only. Fibrin glue sealants were the most common type of sealant used (1,696 cases [66.8%]) in combination with a graft or alone. Based on 4 comparative studies with 540 sealed cases and 343 cases with primary suture closure only, the quantity of CSF leakage did not differ between the sealant group (50/540 [9.1%]) and the suture-only group (48/343 [13.8%]) (risk ratio [RR], 0.58; 95% confidence interval [CI], 0.18 to 1.82). Moreover, the infection rate did not differ between the sealant and primary suture groups as well (RR, 0.94; 95% CI, 0.55 to 1.61). The secondary analysis of all cases showed regardless of sealant use, endoscopic or minimally invasive surgery had lower CSF leakage rates than the open surgery (RR, 0.18; 95% CI, 0.05 to 0.75). This analysis found no difference in the rate of CSF leakage after spinal surgery with fibrin sealant use; however, the rate of CSF leakage was significantly lower in open surgery regardless of sealant usage. Fibrin sealants are not approved for dural sealings, and this analysis found that extra treatment with fibrin glue does not lead to less postoperative CSF leakage than sutures in spinal surgeries. [4]
A 1999 review describes the effective use of fibrin sealant to fix CSF leakages after trauma or surgery in case series. Successful and permanent sealing was seen in all 57 patients who underwent repair of CSF leakage with pedunculated periosteal flaps with fibrin sealant compared to a 42.3% leakage rate in patients who underwent repair with lyophilised dura and cyanoacrylate adhesive. Fibrin sealant usage was also associated with a reduction in length of hospital stay (16.3 vs 27 days). Another case series reported CSF leakage persisted in only 2/15 (13.3%) patients with intraoperative leakage during repair of the septal bone with fibrin sealant on the sellar floor and anterior wall of the sphenoid sinus during transsphenoidal surgery. No leakage was reported over a 12 month period in any of the 104 patients who did not report intraoperative leakage. [5]