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Bioseal Dural Sealing Study BIOS-14-001

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ClinicalTrials.gov Identifier: NCT03110783
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Guangzhou Bioseal Biotechnology Co., Ltd.

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 Type : Interventional  (Clinical Trial)
Estimated 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 : September 14, 2017
Estimated Primary Completion Date : March 19, 2020
Estimated Study Completion Date : March 25, 2021


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.




Primary Outcome Measures :
  1. Proportion of success (watertight closure) CSF leakage [ Time Frame: 5 to 10 seconds after final Valsalva maneuver ]
    no CSF leakage from dural repair intra-operatively


Secondary Outcome Measures :
  1. Incidence of CSF leakage [ Time Frame: Up to Discharge, an average of 3-5days in general ]
    Incidence of CSF leakage post-surgery to discharge

  2. Incidence of CSF leakage [ Time Frame: Up to 30(+/-7)Days ]
    Incidence of CSF leakage 30 (±7) days post operatively

  3. Incidence of adverse events [ Time Frame: Up to 30(±7)Days ]
    Incidence of adverse events

  4. Incidence of surgical site infections (SSI) [ Time Frame: Up to 30(± 7) days ]
    Incidence of surgical site infections (SSI) according to Surgical Site Infection Infection Prevention and Control Guideline (MOH) criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110783


Contacts
Contact: Liya Qiu 13911685032 lqiu10@its.jnj.com

Locations
China, Beijing
Xuanwu Hospital Capital Medical University Terminated
Beijing, Beijing, China, 100053
China, Fujian
The First Affiliated Hospital of Fujian Medical University Not yet recruiting
Fuzhou, Fujian, China, 350005
Contact: Dezhi Kang, MD    13859099988    kdz99988@sina.com   
China, Guangdong
ZhuJiang Hospital of Southern Medical University Not yet recruiting
Guangzhou, Guangdong, China, 510280
Contact: Yiquan Ke, MD, PhD    13380092263    net_chn@hotmail.com   
China, Guizhou
The Affiliated Hospital of Guizhou Medical University Not yet recruiting
Guiyang, Guizhou, China, 550004
Contact: Hua Yang    13985402206      
China, Hubei
TongJi Hospital, TongJi Medical College of HUST Recruiting
Wuhan, Hubei, China, 430030
Contact: Ting Lei, MD, PhD    13808697913    tlei@tjhmu.edu.cn   
China, Jiangsu
The First Affiliated Hospital of Soochow University Not yet recruiting
Suzhou, Jiangsu, China, 215006
Contact: Zhong Wang, MD,PhD    13306208761    w13306208761@hotmail.com   
The Affiliated Hospital of Xuzhou Medical University Recruiting
Xuzhou, Jiangsu, China, 221000
Contact: Rutong Yu, MD, PhD    13182310079    yu.rutong@163.com   
China, Jilin
The First Hospital of Jilin University Not yet recruiting
Changchun, Jilin, China, 130021
Contact: Gang Zhao, MD, PhD    13756661280    2956896370@qq.com   
China, Shanghai
Huashan Hospital, Shanghai Medical College, Fudan University Recruiting
Shanghai, Shanghai, China, 200040
Contact: Ying Mao, MD, PhD    13801769152    yingmao168@hotmail.com   
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.

Responsible Party: Guangzhou Bioseal Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03110783     History of Changes
Other Study ID Numbers: BIOS-14-001
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Guangzhou Bioseal Biotechnology Co., Ltd.:
Bioseal as an Adjunct to Sutured Dural Repair
elective posterior fossa
supratentorial procedure

Additional relevant MeSH terms:
Congenital Abnormalities
Neoplasms
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases