Correction to: Safety and effectiveness of Evicel® fibrin sealant as an adjunct to sutured dural repair in children undergoing cranial neurosurgery (Child's Nervous System, (2024), 40, 9, (2735-2745), 10.1007/s00381-024-06434-4)

Abstract

In Tables 1, 2, 3, 4, 5, 6 of this article, there are sub-entries that requires indentions for readers clarity. Below are the updated tables. (Table presented.) (Table presented.) (Table presented.) (Table presented.) (Table presented.) (Table presented.) Patient Characteristics (ITT Set). Medical history shows disorders that occurred in ≥10% of subjects. Evicel® (N=25) Sutures (N=15) Age (years), median (range) 10.0 (0.8,17.0) 10.0 (0.6,15.0) Male/Female ratio, n (%)/n (%) 14 (56.0 %) / 11 (44.0%) 9 (60.0%) / 6 (40.0%) BMI (kg/m2), median (range) a 18.1 (13.4,33.8) 18.5 (14.0,23.7) Medical History, n (%) Any previous surgery 8 (32.0%) 4 (26.7%) Neoplasms 16 (64.0%) 11 (73.3%) Nervous system disorders 14 (56.0%) 12 (80.0%) Congenital/genetic disorders 9 (36.0%) 4 (26.7%) Immune disorders 4 (16.0%) 0 Cardiac disorders 2 (8.0%) 2 (13.3%) Infectious disorders 4 (16.0%) 0 a Evicel® n=15, Sutures n=10 Procedural Characteristics (ITT Set). Evicel® (N=25) Sutures (N=15) Procedure type, n subjects (% of total N) Craniotomy 24 (96.0%) 15 (100.0%) Craniectomy 1 (4.0%) 0 (0.0%) Approach, n subjects (% of total N) Infratentorial 4 (16.0%) 3 (20.0%) Intracranial tumor 3 (12.0%) 3 (20.0%) Chiari malformation 1 (4.0%) 0 Supratentorial 21 (84.0%) 12 (80.0%) Intracranial tumor 13 (52.0%) 9 (60.0%) Epilepsy 6 (24.0%) 1 (6.7%) A-V malformation 2 (8.0%) 1 (6.7%) Arachnoid cyst 0 1 (6.7%) CSF leak before randomization, n subjects (% of total N) Spontaneous 14 (56.0%) 10 (66.7%) After Valsalva Maneuver 11 (44.0%) 5 (33.3%) Duration of surgery, min, median (range) a 305 (123, 452) 288 (188, 675) Time in operation room, min, median (range) a 376 (160, 561) 361 (214, 778) Postoperative hospital stay, nights, median (range) 5 (2, 25) 7 (2, 35) a Evicel® n=23, Sutures n=14. Treatment Parameters and Intra-operative Outcomes (Safety Set). Evicel® Number of layers within each treatment, n subjects (% of total N = 26) 1st Treatment 1 layer 18 (69.2%) 2 layers 8 (30.8%) 2nd Treatment 1 layer 1 (3.9%) 2 layers 2 (7.7%) Intra-operative outcome following each treatment, n subjects (% of total N = 26) No CSF Leak 23 (88.5%) CSF Leak 3 (11.5%) No CSF Leak 0 CSF Leak 3 (11.5%) Rescue treatment, n subjects (%) 3 (11.5%)a Number of additional sutures, median (range) 2.0 (1.0,12.0) Additional treatment for durability, n subjects (%) 1 (7.1%) b Intra-operative outcome, n subjects (% of total N) No CSF leak 5 (35.7%) CSF leak 9 (64.3%) Rescue treatment, n subjects (% of total N) 9 (64.3%)caInfratentorial: DuraSeal® n = 1, Surgicel® + Duragen® + Duraguard® n = 1. Supratentorial: Tisseel® + Surgicel® n = 1 bSurgicel® Fibrillar cInfratentorial: Pericranium n = 1, Adherus® + Duraguard® n = 1. Supratentorial: Tisseel® n = 2, Tisseel® + Surgicel® n = 1, Tisseel® + Duragen® n = 1, Tisseel® + Surgicel® + fascia n = 1, Surgicel® + Gelfoam® n = 1, Gelfoam® + Spongostan® n = 1 Primary Efficacy Analysis and Sensitivity Analyses. Success was defined as the achievement of intra-operative watertight closure after completion of the randomized treatment, as assessed by provocative testing with Valsalva maneuver. Evicel® Success Rate % (n/N) Sutures Success Rate % (n/N) Estimated PE/PS Farrington-Manning 95% CI for PE/PS Overall group 92.0% (23/25) 33.3% (5/15) 2.76 (1.53, 6.16) Infratentorial 50.0% (2/4) 0.0% (0/3) Supratentorial 100.0% (21/21) 41.7% (5/12) Overall group 90.9% (20/22) 40.0% (4/10) 2.27 (1.27, 5.53) Overall group 88.5% (23/26) 35.7% (5/14) 2.48 (1.39, 5.52) PE/PS, Proportion successes in Evicel® group / Proportion successes in Sutures group CI, Confidence Interval Adverse Events and Relatedness to Study Product (Determined for Evicel® Group Only) and Procedure (Safety Set). Evicel® (N=26) Sutures (N=14) Individual AEs 118 110 Related or possibly related to study product 0 N/A Related or possibly related to study procedure 71 (60.2%) 73 (66.4%) Individual SAEs 7 16 a Related or possibly related to study product 1 (3.8%) b N/A Related or possibly related to study procedure 6 (85.7%) c 14 (87.5%) d ≥ 1 AE 22 (84.6%) 14 (100.0%) ≥ 1 Serious AE 5 (19.2%) 8 (57.1%) ≥ 1 Severe AE 2 (7.7%) 1 (7.1%) ≥ 1 AE related or possibly related to product 0 N/A ≥ 1 SAE related or possibly related to product 1 (3.8%) b N/A ≥ 1 AE related or possibly related to procedure 21 (80.8%) 12 (85.7%) ≥ 1 SAE related or possibly related to procedure 5 (19.2%) 7 (50.0%) a Partial seizure, neurofibromatosis and 14 other SAE as detailed in footnote (d) b Pseudomeningocele (Causality upgraded by Sponsor) c Diabetes insipidus, pyrexia, meningitis, medulloblastoma recurrence, convulsive seizure, hydrocephalus (due to malfunction existing CSF shunt), d Pseudomeningocele with iCSF leak (n=1), pseudomeningocele without iCSF leak (n=4), hematoma (n=2), vomiting (n=1), hemorrhagic cyst (n=1), shunt infection (n=1), pneumocephalus (n=1), transverse sinus thrombosis (n=1), hydrocephalus (due to malfunction existing CSF shunt) n=1, hydrocephalus (due to choroid plexus carcinoma and intraventricular blood collection) n=1. Surgical Site Complications Observed within 30 Days Postoperatively (Safety Set). All complications are also reported as AEs (Table 5). Surgical site complications, n subjects (%) Evicel® (N=26) Sutures (N=1 ≥ 1 surgical site complication 9 (34.6%) 8 (57.1%) CSF leakage 1 (3.8%) 5 (35.7%) Incisional CSF leakage 0 0 Pseudomeningocele 1 (3.8%) a 4 (28.6 %) b Pseudomeningocele and incisional CSF leakage 0 1 (7.1%) c Infection 1 (3.8%) 1 (7.1%) Hematoma 1 (3.8%) 1 (7.1%) Other 6 (23.1%) d 6 (42.9%) ea No treatment needed. b Treated with CSF shunt (n=2), no treatment needed (n=2). c Treated with pressure bandage and re-suturing. d Itchy wound, soreness/numbness, hydrocephalus (due to malfunction existing CSF shunt), subgaleal collection, subgaleal swelling, weeping sutures. e Hydrocephalus (due to intraventricular blood collection), hydrocephalus (due to malfunction existing CSF shunt), non-occlusive sinus transversus thrombus, wound swelling, pneumocephalus, bruising. The original article has been corrected.