A Prospective, Randomized, Controlled, Single Blinded, Study to Evaluate the Safety and Effectiveness of Bioseal as an Adjunct to Sutured Dural Repair

Guangzhou Bioseal Biotechnology Co., Ltd.10 sites in 1 country200 target enrollmentSeptember 14, 2017

ConditionsBenign Tumors Malignant Tumors Vascular Malformation

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Benign Tumors
Sponsor: Guangzhou Bioseal Biotechnology Co., Ltd.
Enrollment: 200
Locations: 10
Primary Endpoint: Proportion of success (watertight closure) CSF leakage
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A Prospective, Randomized, Controlled, Single Blinded, Study to Evaluate the Safety and Effectiveness of Bioseal as an Adjunct to Sutured Dural Repair

Detailed Description

This is a randomized, single blinded, multi-center controlled study evaluating the effectiveness of Bioseal as an adjunct to sutured dural closure compared to control to obtain an intra-operative watertight dural closure.

Registry

clinicaltrials.gov

Start Date

September 14, 2017

End Date

September 20, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Guangzhou Bioseal Biotechnology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Preoperative
•Patient undergoing elective craniotomy/craniectomy for pathological processes (such as benign and malignant tumors, vascular malformation) in the posterior fossa or in the supratentorial region.
•Age ≥ 18 years.
•Patients who are able and willing to comply with the procedures required by the protocol.
•Signed and dated written informed consent from the subject or from his/her legal representative prior to any study-specific procedures.
•Intraoperative
•Patient undergoing elective craniotomy/craniectomy for pathological processes (such as benign and malignant tumors, vascular malformation) in the posterior fossa or in the supratentorial region and who are demonstrated to have persistent CSF leakage following suture closure of the dural incision. CSF leakage will be evaluated during a period of Valsalva of 10-20 cm of H20 for 5-10 seconds. If a spontaneous leak is apparent immediately after dural closure, no Valsalva will be performed.
•Surgical wound classification Class I. Penetration of mastoid air cells during partial mastoidectomy is permitted.
•The cuff of native dura along the craniotomy edge is ≥10 mm wide, to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product.

Exclusion Criteria

•Preoperative
•Subjects with a dura lesion from a recent surgery that still has the potential for CSF leakage.
•The previous craniotomy/ craniectomy within 6 months or radiation therapy within 2 years before this surgery.
•Chemotherapy or radiation therapy scheduled within 7 days following surgery.
•Subjects with severely altered renal (serum creatinine \>2 mg/dL) and/or hepatic function \[ALT, AST \> 5 x upper limit of norm (ULN)\].
•Severe Anemia (Hemoglobin \<60 g/L) or Hypoproteinemia (Total protein \<60 g/L or 6g% ) .
•Non-compliant or insufficient treatment of diabetes mellitus \[glycosylated hemoglobin (HbA1c) \> 7.5%\].
•Conditions compromising the immune system; existence of autoimmune disease.
•Evidence of a potential infection: fever \>38℃, WBC \<3500/uL or \>13000/uL, positive urine culture, positive blood culture, positive chest X-ray, evidence of infection along the planned surgical path.
•Known hypersensitivity to the porcine fibrin sealant product.