Bioseal Dural Sealing Study BIOS-14-001 (NCT03110783) | Clinical Trial Compass
CompletedPhase 3
Bioseal Dural Sealing Study BIOS-14-001
China200 participantsStarted 2017-09-14
Plain-language summary
A Prospective, Randomized, Controlled, Single Blinded, Study to Evaluate the Safety and Effectiveness of Bioseal as an Adjunct to Sutured Dural Repair
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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
. Subjects with a dura lesion from a recent surgery that still has the potential for CSF leakage.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of success (watertight closure) CSF leakage
Timeframe: 5 to 10 seconds after final Valsalva maneuver
. 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.