Bioseal Dural Sealing Study BIOS-14-001

Sponsor

Guangzhou Bioseal Biotechnology Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03110783

Collaborator

(none)

200

Enrollment

Locations

Arms

24.2

Actual Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Benign Tumors Malignant Tumors Vascular Malformation	Biological: Bioseal	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 14, 2017

Actual Primary Completion Date :

Sep 20, 2019

Actual Study Completion Date :

Sep 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: suture (control) 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.
Experimental: Bioseal 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 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.

Arm

Intervention/Treatment

No Intervention: suture (control)

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.

Experimental: Bioseal

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

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.

Outcome Measures

Primary Outcome Measures

Proportion of success (watertight closure) CSF leakage [5 to 10 seconds after final Valsalva maneuver]
no CSF leakage from dural repair intra-operatively

Secondary Outcome Measures

Incidence of CSF leakage [Up to Discharge, an average of 3-5days in general]
Incidence of CSF leakage post-surgery to discharge
Incidence of CSF leakage [Up to 30(+/-7)Days]
Incidence of CSF leakage 30 (±7) days post operatively
Incidence of adverse events [Up to 30(±7)Days]
Incidence of adverse events
Incidence of surgical site infections (SSI) [Up to 30(± 7) days]
Incidence of surgical site infections (SSI) according to Surgical Site Infection Infection Prevention and Control Guideline (MOH) criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
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.
Use of implants made of synthetic materials coming into direct contact with dura (e.g., PTFE patches, shunts, ventricular and subdural drains).
Occlusive hydrocephalus caused by posterior fossa pathology or partial blockage of CSF pathways during surgical procedure.
Existing CSF drains on the surgical path.
Use of other fibrin sealants for hemostasis.
Placement of Gliadel Wafers or similar products.
Persistently increased brain surface tension that may lead to an incomplete repair requiring.
Intersecting durotomy scars in the surgical path from a previous operation that cannot be completely removed by the planned dura resection.
Two or more separate dura defects during surgery.
Others in addition to above exclusion criteria, the subject, in the opinion of the investigator, would not be suitable for participation in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xuanwu Hospital Capital Medical University	Beijing	Beijing	China	100053
2	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	China	350005
3	ZhuJiang Hospital of Southern Medical University	Guangzhou	Guangdong	China	510280
4	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou	China	550004
5	The first Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China
6	TongJi Hospital, TongJi Medical College of HUST	Wuhan	Hubei	China	430030
7	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215006
8	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu	China	221000
9	The First Hospital of Jilin University	Changchun	Jilin	China	130021
10	Huashan Hospital, Shanghai Medical College, Fudan University	Shanghai	Shanghai	China	200040

Sponsors and Collaborators

Guangzhou Bioseal Biotechnology Co., Ltd.

Investigators

Principal Investigator: Ying Mao, MD, PhD, Hua Shan Hospital, Shanghai Medical College, Fudan University
Study Director: Richard Kocharian, MD, PhD, Ethicon, Inc.