Bioseal Dural Sealing Study BIOS-14-001

NCT03110783 | Completed Phase 3

• 1 other identifier: BIOS-14-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Benign Tumors; Malignant Tumors; Vascular Malformation

Keywords

Bioseal as an Adjunct to Sutured Dural Repair; elective posterior fossa; supratentorial procedure

Outcome Measures

Primary Outcomes (1)

• Proportion of success (watertight closure) CSF leakage

  no CSF leakage from dural repair intra-operatively

  5 to 10 seconds after final Valsalva maneuver

Secondary Outcomes (4)

• Incidence of CSF leakage

  Up to Discharge, an average of 3-5days in general

• Incidence of CSF leakage

  Up to 30(+/-7)Days

• Incidence of adverse events

  Up to 30(±7)Days

• Incidence of surgical site infections (SSI)

  Up to 30(± 7) days

Study Arms (2)

suture (control)

NO INTERVENTION

Subjects randomized to control will receive additional dural sutures as deemed necessary by the surgeon. CSF leakage will be re-evaluated with the Valsalva maneuver to 10-20 cm H2O for 5 to 10 seconds. Closure of the remaining layers of the surgical site will be performed according to the surgeon's standard of practice.

Bioseal

EXPERIMENTAL

Subjects randomized to receive Bioseal, a thin layer will be applied to the entire length of the suture line and the adjacent area to approximately 5mm away, including all suture holes. Up to two layers of Bioseal may be used for each application. While Bioseal achieves complete coagulation, CSF leakage will be re-evaluated with the Valsalva maneuver to 10-20 cm H2O for 5 to 10 seconds. Up to two applications (one application includes applying up to two layers of Bioseal product followed by the CSF leakage re-evaluation with Valsalva maneuver) per subject are allowed. Closure of the remaining layers of the surgical site will be performed according to the surgeon's standard of practice.

Biological: Bioseal

Interventions

Bioseal BIOLOGICAL

Upon completion of the sutured dural repair, the closure will be evaluated for intra-operative CSF leakage with a baseline Valsalva maneuver to 10-20 cm H2O for 5-10 seconds. Subjects who have a CSF leak will be enrolled into the study. If randomized to receive Bioseal, a thin layer will be applied to the entire length of the suture line and the adjacent area to approximately 5mm away, including all suture holes. Up to two layers of Bioseal may be used for each application. While Bioseal achieves complete coagulation, CSF leakage will be re-evaluated with the Valsalva maneuver to 10-20 cm H2O for 5 to 10 seconds.

Bioseal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Female subjects of childbearing potential with a positive urine or serum pregnancy test within 7 days prior to surgery.
• Female subjects who are breastfeeding or intend to become pregnant during the clinical study period.
• Participation in another clinical trial with exposure to another investigational drug or device within 30 days prior to enrolment.
• Intraoperative
• Native dura cuff during craniotomy/craniectomy that cannot be completely repaired.

Sponsors & Collaborators

• Guangzhou Bioseal Biotechnology Co., Ltd.: lead

Study Sites (10)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

Location

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550004, China

Location

The first Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

TongJi Hospital, TongJi Medical College of HUST

Wuhan, Hubei, 430030, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Huashan Hospital, Shanghai Medical College, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (1)

• Du S, Zhao J, Qiao G, Wu S, Han Y. Cost-Effectiveness Analysis of the Application of a Porcine-Derived Fibrin Sealant for the Treatment of Cerebrospinal Fluid Leak in China. Clin Ther. 2022 Apr;44(4):575-584. doi: 10.1016/j.clinthera.2022.02.010. Epub 2022 Apr 19.

  PMID: 35450755 DERIVED

MeSH Terms

Conditions

Neoplasms; Vascular Malformations

Interventions

Bioseal

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ying Mao, MD, PhD

  Hua Shan Hospital, Shanghai Medical College, Fudan University

  PRINCIPAL INVESTIGATOR

• Richard Kocharian, MD, PhD

  Ethicon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 12, 2017
• Study Start: September 14, 2017
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2019
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

CN (10)