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Benign TumorsPhase 3NCT03110783

Bioseal Dural Sealing Study BIOS-14-001

A Phase 3 study testing Bioseal in people with Benign Tumors and Malignant Tumors, run by Guangzhou Bioseal Biotechnology Co., Ltd. at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Bioseal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
10 sitesChina
Study dates
14 Sep 2017to 20 Sep 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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% ) .
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  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality, 100053

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • ZhuJiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550004

  • Huashan Hospital, Shanghai Medical College, Fudan University

    Shanghai, Shanghai Municipality, 200040

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • TongJi Hospital, TongJi Medical College of HUST

    Wuhan, Hubei, 430030

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

  • The first Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

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

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

Read the 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.

Being tested
Bioseal
Keywords
Bioseal as an Adjunct to Sutured Dural Repair, elective posterior fossa, supratentorial procedure
Medical subject headings
Neoplasms, Vascular Malformations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiosealBiological

    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.

Study groups in NCT03110783
Study groupRoleWhat they receive
suture (control)No interventionSubjects 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.
BiosealExperimentalSubjects 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.
Receives: Biological: Bioseal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of success (watertight closure) CSF leakage

    no CSF leakage from dural repair intra-operatively

    Measured: 5 to 10 seconds after final Valsalva maneuver

Secondary outcomes (4)

  1. Incidence of CSF leakage

    Incidence of CSF leakage post-surgery to discharge

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

  2. Incidence of CSF leakage

    Incidence of CSF leakage 30 (±7) days post operatively

    Measured: Up to 30(+/-7)Days

  3. Incidence of adverse events

    Incidence of adverse events

    Measured: Up to 30(±7)Days

  4. Incidence of surgical site infections (SSI)

    Incidence of surgical site infections (SSI) according to Surgical Site Infection Infection Prevention and Control Guideline (MOH) criteria

    Measured: Up to 30(± 7) days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2017
  2. Study start14 Sep 2017
  3. Primary completion20 Sep 2019
  4. Study completion20 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03110783
Sponsor's protocol ID
BIOS-14-001
Status last verified
Nov 2019
First submitted
22 Mar 2017
Last updated
18 Nov 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35450755

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bioseal in people with Benign Tumors and Malignant Tumors, run by Guangzhou Bioseal Biotechnology Co., Ltd. at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of success (watertight closure) CSF leakage (time frame: 5 to 10 seconds after final Valsalva maneuver). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03110783, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019; AzTrials last refreshed its copy on 27 Oct 2026.

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