Bioseal Dural Sealing Study BIOS-14-001

Malignant Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03110783
• Other study ID #: BIOS-14-001
• Status: Completed
• Phase: Phase 3
• Start date: September 14, 2017
• Est. completion date: September 20, 2019

Study information

• Verified date: November 2019
• Source: Guangzhou Bioseal Biotechnology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 20, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Preoperative

1. 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.

2. Age = 18 years.

3. Patients who are able and willing to comply with the procedures required by the protocol.

4. Signed and dated written informed consent from the subject or from his/her legal representative prior to any study-specific procedures.

• Intraoperative

1. 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.

2. Surgical wound classification Class I. Penetration of mastoid air cells during partial mastoidectomy is permitted.

3. 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

1. Subjects with a dura lesion from a recent surgery that still has the potential for CSF leakage.

2. The previous craniotomy/ craniectomy within 6 months or radiation therapy within 2 years before this surgery.

3. Chemotherapy or radiation therapy scheduled within 7 days following surgery.

4. Subjects with severely altered renal (serum creatinine >2 mg/dL) and/or hepatic function [ALT, AST > 5 x upper limit of norm (ULN)].

5. Severe Anemia (Hemoglobin <60 g/L) or Hypoproteinemia (Total protein <60 g/L or 6g% ) .

6. Non-compliant or insufficient treatment of diabetes mellitus [glycosylated hemoglobin (HbA1c) > 7.5%].

7. Conditions compromising the immune system; existence of autoimmune disease.

8. 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.

9. Known hypersensitivity to the porcine fibrin sealant product.

10. Female subjects of childbearing potential with a positive urine or serum pregnancy test within 7 days prior to surgery.

11. Female subjects who are breastfeeding or intend to become pregnant during the clinical study period.

12. Participation in another clinical trial with exposure to another investigational drug or device within 30 days prior to enrolment.

• Intraoperative

1. Native dura cuff during craniotomy/craniectomy that cannot be completely repaired.

2. Use of implants made of synthetic materials coming into direct contact with dura (e.g., PTFE patches, shunts, ventricular and subdural drains).

3. Occlusive hydrocephalus caused by posterior fossa pathology or partial blockage of CSF pathways during surgical procedure.

4. Existing CSF drains on the surgical path.

5. Use of other fibrin sealants for hemostasis.

6. Placement of Gliadel Wafers or similar products.

7. Persistently increased brain surface tension that may lead to an incomplete repair requiring.

8. Intersecting durotomy scars in the surgical path from a previous operation that cannot be completely removed by the planned dura resection.

9. Two or more separate dura defects during surgery.

10. Others in addition to above exclusion criteria, the subject, in the opinion of the investigator, would not be suitable for participation in the study.

Related Conditions & MeSH terms

• Benign Tumors
• Malignant Tumors
• Neoplasms
• Vascular Malformation
• Vascular Malformations

Intervention

Biological:
• Bioseal
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.

Locations

Country	Name	City	State
China	Xuanwu Hospital Capital Medical University	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	ZhuJiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	Huashan Hospital, Shanghai Medical College, Fudan University	Shanghai	Shanghai
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	TongJi Hospital, TongJi Medical College of HUST	Wuhan	Hubei
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	The first Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Bioseal Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of success (watertight closure) CSF leakage	no CSF leakage from dural repair intra-operatively	5 to 10 seconds after final Valsalva maneuver
Secondary	Incidence of CSF leakage	Incidence of CSF leakage post-surgery to discharge	Up to Discharge, an average of 3-5days in general
Secondary	Incidence of CSF leakage	Incidence of CSF leakage 30 (±7) days post operatively	Up to 30(+/-7)Days
Secondary	Incidence of adverse events	Incidence of adverse events	Up to 30(±7)Days
Secondary	Incidence of surgical site infections (SSI)	Incidence of surgical site infections (SSI) according to Surgical Site Infection Infection Prevention and Control Guideline (MOH) criteria	Up to 30(± 7) days