A single blinded, randomized, controlled study to evaluate the safety and effectiveness of EVICEL® Fibrin sealant (Human) compared to a Hydrogel

INTERVENTION: Trade Name: EVICEL® Product Name: EVICEL® Pharmaceutical Form: Solution for sealant INN or Proposed INN: HUMAN CLOTTABLE PROTEIN CAS Number: 9001‐32‐5 Other descriptive name: HUMAN CLOTTABLE PROTEIN CONTAINING MAINLY FIBRINOGEN AND FIBRONECTIN Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 50‐90 INN or Proposed INN: Human Thrombin CAS Number: 9002‐04‐4 Other descriptive name: HUMAN THROMBIN Concentration unit: IU/ml international unit(s)/millilitre Concentration type: range Concentration number: 800‐1200 CONDITION: Cerebrospinal fluid leakage in posterior fossa or supratentorial procedures (craniectomy or craniotomy) during neurosurgery Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Surgical Procedures, Operative [E04] PRIMARY OUTCOME: Main Objective: The objective of this study is to evaluate the safety and efficacy of EVICEL® Fibrin Sealant (Human) for use as an adjunct to sutured dural repair in cranial surgery Primary end point(s): The proportion of subjects that do not have a CSF leak during surgery and up to the 30 day (± 7) post operative period. Secondary Objective: Not applicable Timepoint(s) of evaluation of this end point: Starting from randomization and up to the 30 day (± 7) post operative period. SECONDARY OUTCOME: Secondary end point(s): 1. Incidence of Intra operative CSF leakage following final Valsalva maneuver. ; 2. Incidence of post operative CSF leakage within 30 (±7) days postoperatively. ; 3. Incidence of post operative CSF leakage within 60 (± 14) days postoperatively. ; 4. Incidence of adverse events. ; 5. Incidence of surgical site infections (SSI) according to NNIS definition and CDC classification within 30 days (±7) post operatively. Timepoint(s) of evaluation of this end point: From surgery up to the 60 day (± 14) post operative period. INCLUSION CRITERIA: Pre‐Operative 1.Subjects =18 years of age undergoing craniotomy/craniectomy for pathological processes in the supratentorial region or posterior fossa (such as benign or malignant tumors, vascular malformation, and Chiari 1 malformations); 2.Subjects or legally authorized representatives must be willing to participate in the study and provide written informed consent. Intra‐Operative 1.Surgical wound classification Class I. Superficial penetration of mastoid air cells during partial mastoidectomy is permitted. 2.The cuff of native dura along the craniotomy edge on each side is adequate, based on surgeon’s judgment, to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product. 3.Presence of intra‐operative cerebrospinal fluid (CSF) leakage following primary dural closure or after Valsalva maneuver Are the trial subjects under 18? no Number of subjects for this age range:

Epistemonikos ID: 9455ab68adcc1a8cf82ca6cd61afe3ebf80898ba
First added on: Aug 24, 2024