Correction to: Safety and effectiveness of Evicel® fibrin sealant as an adjunct to sutured dural repair in children undergoing cranial neurosurgery

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Correction to: Child’s Nervous System

https://doi.org/10.1007/s00381-024-06434-4

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 1. 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/m^2^), median (range) ^a^18.1 (13.4,33.8)18.5 (14.0,23.7)Medical History, n (%)  Any previous surgery8 (32.0%)4 (26.7%)  Neoplasms16 (64.0%)11 (73.3%)  Nervous system disorders14 (56.0%)12 (80.0%)  Congenital/genetic disorders9 (36.0%)4 (26.7%)  Immune disorders4 (16.0%)0  Cardiac disorders2 (8.0%)2 (13.3%)  Infectious disorders4 (16.0%)0^a^ Evicel® n=15, Sutures n=10Table 2Procedural Characteristics (ITT Set).Evicel® (N=25)Sutures (N=15)Operative procedure  Procedure type, n subjects (% of total N)    Craniotomy24 (96.0%)15 (100.0%)    Craniectomy1 (4.0%)0 (0.0%)  Approach, n subjects (% of total N)    Infratentorial4 (16.0%)3 (20.0%)      Intracranial tumor3 (12.0%)3 (20.0%)      Chiari malformation1 (4.0%)0    Supratentorial21 (84.0%)12 (80.0%)      Intracranial tumor13 (52.0%)9 (60.0%)      Epilepsy6 (24.0%)1 (6.7%)      A-V malformation2 (8.0%)1 (6.7%)      Arachnoid cyst01 (6.7%)  CSF leak before randomization, n subjects (% of total N)    Spontaneous14 (56.0%)10 (66.7%)    After Valsalva Maneuver11 (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.Table 3. Treatment Parameters and Intra-operative Outcomes (Safety Set).Evicel®N = 26Number of layers within each treatment, n subjects (% of total N = 26)    1^st^* Treatment1 layer18 (69.2%)2 layers8 (30.8%)    2^nd^ Treatment1 layer1 (3.9%)2 layers2 (7.7%)Intra-operative outcome following each treatment, n subjects (% of total N = 26)    1st TreatmentNo CSF Leak23 (88.5%)CSF Leak 3 (11.5%)    2nd TreatmentNo CSF Leak0CSF Leak3 (11.5%)Rescue treatment, n subjects (%)3 (11.5%)^a^**SuturesN = 14Number 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 leak5 (35.7%)CSF leak9 (64.3%)Rescue treatment, n subjects (% of total N)9 (64.3%)^c^^a^Infratentorial: DuraSeal® n = 1, Surgicel® + Duragen® + Duraguard® n = 1. Supratentorial: Tisseel® + Surgicel® n = 1^b^Surgicel® Fibrillar^c^Infratentorial: 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 = 1Table 4Primary 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)SuturesSuccess Rate% (n/N)Estimated P_E_/P_S_Farrington-Manning95% CI for P_E_/P_S_Intention-to-treat set*  Overall group92.0% (23/25)33.3% (5/15)2.76(1.53, 6.16)    Infratentorial50.0% (2/4)0.0% (0/3)    Supratentorial100.0% (21/21)41.7% (5/12)Per protocol set  Overall group90.9% (20/22)40.0% (4/10)2.27(1.27, 5.53)Safety set  Overall group88.5% (23/26)35.7% (5/14)2.48(1.39, 5.52)P_E_/P_S_, Proportion successes in Evicel® group / Proportion successes in Sutures groupCI, Confidence IntervalTable 5Adverse Events and Relatedness to Study Product (Determined for Evicel® Group Only) and Procedure (Safety Set).Evicel® (N=26)Sutures (N=14)Individual AE, n (%)  Individual AEs118110    Related or possibly related to study product0N/A    Related or possibly related to study procedure71 (60.2%)73 (66.4%)  Individual SAEs716 ^a^    Related or possibly related to study product1 (3.8%) ^b^N/A    Related or possibly related to study procedure6 (85.7%) ^c^14 (87.5%) ^d^Subjects with AE, n (%)  ≥ 1 AE22 (84.6%)14 (100.0%)  ≥ 1 Serious AE5 (19.2%)8 (57.1%)  ≥ 1 Severe AE2 (7.7%)1 (7.1%)  ≥ 1 AE related or possibly related to product0N/A  ≥ 1 SAE related or possibly related to product1 (3.8%) ^b^N/A  ≥ 1 AE related or possibly related to procedure21 (80.8%)12 (85.7%)  ≥ 1 SAE related or possibly related to procedure5 (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.Table 6. 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 complication9 (34.6%)8 (57.1%)CSF leakage1 (3.8%)5 (35.7%)        Incisional CSF leakage00        Pseudomeningocele1 (3.8%) ^a^4 (28.6 %) ^b^        Pseudomeningocele and incisional CSF leakage01 (7.1%) ^c^Infection1 (3.8%)1 (7.1%)Hematoma1 (3.8%)1 (7.1%)Other6 (23.1%) ^d^6 (42.9%) ^e^^a^ 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.