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Cerebrospinal Fluid LeakageNCT06419855

Study to Evaluate the Effectivity and Safety of BIOSCAFF®H Compared to DuraGen®, in Patients Undergoing Dural Repair

An observational study of Cerebrospinal Fluid Leakage, run by Top Health S.A.P.I DE C.V. at 4 sites in Mexico.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Study in which the presence or absence of symptoms or any health condition is observed and recorded 30 days after a cranial surgery in which the physician places a material or graft, either BIOSCAFF®H or DuraGen®, into the skull; this material allows the regeneration of tissue that makes up one of the layers of the… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Cerebrospinal Fluid Leakage
What is being tested?
Human collagen matrix graft and Bovine collagen matrix graft
Type of treatment
Medical device
How many people
2 participants
Where
4 sitesMexico
Study dates
3 Sep 2024to 18 Feb 2025
Phase
Observational
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients of private and public clinical care, who have undergone dural surgery, residents of different states of Mexico

Who may be able to join

  • Adults ≥18 years of age up to 70 years of age, of both sexes.
  • Patients who agree to participate and are able to provide written informed consent.
  • Patients who underwent dural surgery or duraplasty for pathological processes or who required dural grafting at the neurosurgeon's discretion with a maximum of 30 days postoperatively.
  • Patients in need of an incision of at least 2 cm in length.

Who cannot join

  • Presence of empyema/subdural abscess or any type of systemic infection affecting/infiltrating the dura mater detected by the physician prior to surgery.
  • Diagnosis of malignant cranial tumor(NOTE: patients without a diagnosis of malignancy will still be allowed to enter the study).
  • The diagnosis of malignancy will be considered according to the classification of Tumors of the Central Nervous System, stipulated by the World Health Organization version 2021, considering the lowest taxonomic hierarchy (specific) of the tumor available in the diagnosis considering: Category, family or class, type and subtype.
  • The ICD-O morphological coding system will be used, to classify tumors as benign (Eligible) and malignant (Ineligible), considering: /0 for benign tumors; /1 nonspecific, borderline or of uncertain behavior as tumors that can be included in the study, while those coded as /2, /3 and /6 or metastatic tumors as ineligible. In APPENDIX 4 "Patient eligibility associated with the listing of tumors in the central nervous system" the classification of tumors according to the above-mentioned document is listed for clearer reference.
  • Drowsy or comatose patients at the time of screening.
  • Serum creatinine levels >2.0 mg/dL.
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  • Patient with a total bilirubin level >2.5 mg/dL.
  • Previous surgery at the same site or patients with a previous craniotomy/craniectomy within 6 months prior to the study surgery.
  • Inability to read and understand protocol information by the participant.
  • History of symptomatic hydrocephalus.
  • Patients who have received chemotherapy or radiation therapy in the surgical region that was completed within 3 months prior to the planned surgery or are scheduled for the next 12 weeks.
  • Known history of hemophilia or other clinically significant coagulopathy.
  • Previous participation in any related device or investigational drug study within 30 days prior to screening.
  • Medical history report of status epilepticus in the patient.
  • Patients with uncontrolled diabetes according to ADA criteria: fasting glucose ≥200 mg/dL, HbA1C ≥8.5%.
  • Patients in whom radiological contrast medium is contraindicated.
  • Women who are breastfeeding or pregnant.
  • Patients with a body mass index (BMI) ≥ 35 kg/m2.

Trial locations and contacts

4 sites in 1 country.

Mexico4 sites

  • CIMeT Scientific Corporation S.A.P.I. DE C.V.

    Guadalajara, Jalisco, 44340

  • Bind Investigaciones S.C.

    San Luis Potos, San Luis Potos, 78213

  • Faicic S. de R.L. de C.V.

    Veracruz, Veracruz, 91900

  • Investigación Biomédica para el Desarrollo de Fármacos S.A de C.V.

    Zapopan, Jalisco, 45070

Other trials in Mexico

About this study

Official title: Post-approval, Multicenter Study to Evaluate the Efficacy and Safety of BIOSCAFF®H, a Human Collagen Graft, Compared to DuraGen®, a Bovine-derived Graft, in Patients Undergoing Dural Repair Following Cranial Surgery

Study in which the presence or absence of symptoms or any health condition is observed and recorded 30 days after a cranial surgery in which the physician places a material or graft, either BIOSCAFF®H or DuraGen®, into the skull; this material allows the regeneration of tissue that makes up one of the layers of the brain that was affected before or during surgery. The primary hypothesis of this study is that there will be no more than a 10% difference in outcomes between the BIOSCAFF®H device and the active comparator, DuraGen®, with respect to the incidence of cerebrospinal fluid leak or the presence of pseudomeningocele.

Read the detailed description

This study will help describe the safety profile and other aspects such as quality of life of the subjects who received it. The primary objective of the study is to evaluate the efficacy of the BIOSCAFF® H graft in patients undergoing dural surgery in the absence of cerebrospinal fluid leakage compared to the active comparator.

This is a prospective, multicenter, cohort, post-approval study to evaluate the efficacy and safety of BIOSCAFF®H. It consists of a screening period and a follow-up period up to 52 weeks after surgery. Medical records of patients who underwent surgery less than 30 days post-operatively and were implanted with the BIOSCAFF®H human collagen dural substitute or the active bovine collagen-based comparator, DuraGen®, will be considered. It is estimated that approximately 86 dural surgery patients will be enrolled.

Being tested
Human collagen matrix graft, Bovine collagen matrix graft
Keywords
Dural surgery, Sealing, Leakage, Cerebrospinal fluid, Collagen matrix graft, Dura
Medical subject headings
Cerebrospinal Fluid Leak

What participants receive

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

  • Human collagen matrix graftDevice

    Is a porous cross-linked human collagen Matrix or Sponge, used as a scaffold in the repair and restoration of dura mater defects, following craniotomy, laminectomy or in general when there is intentional (surgical procedure) or accidental damage to the dura mater.

  • Bovine collagen matrix graftDevice

    Is a porous type 1 collagen matrix derived from bovine Achilles tendon, this matrix is absorbed after 8 weeks and is used for the repair and restoration of dura mater defects.

Study groups in NCT06419855
Study groupRoleWhat they receive
Human collagen matrix graftIs a porous cross-linked human collagen Matrix or Sponge, used as a scaffold in the repair and restoration of dura mater defects, following craniotomy, laminectomy or in general when there is intentional (surgical procedure) or accidental damage to the dura mater.
Receives: Device: Human collagen matrix graft
Bovine collagen matrix graftIs a porous type 1 collagen matrix derived from bovine Achilles tendon, this matrix is absorbed after 8 weeks and is used for the repair and restoration of dura mater defects.
Receives: Device: Bovine collagen matrix graft

What is being measured

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

  1. Incidence of cerebrospinal fluid leakage

    To evaluate effectiveness of BIOSCAFF®️H graph in patients who underwent dural surgery on the incidence of cerebrospinal fluid leakage versus an active comparator

    Measured: 52 weeks post-surgery

Secondary outcomes (5)

  1. To evaluate the safety of BIOSCAFF®️H in relation to DuraGen®️ at 60, 90 and 180 days post-surgery in patients who underwent dural surgery compared to day 30 post-surgery using the Modified Rankin Score (mRS-9Q).

    To evaluate the safety of BIOSCAFF®️H in relation to DuraGen®️ using the Modified Rankin Score (mRS-9Q), It consists of 9 questions to evaluate the degree of disability of the patient, with a minimum value of 0 indicating no symptoms and a maximum value of 5 indicating severe disability.

    Measured: 180 days post-surgery

  2. To evaluate the safety of BIOSCAFF®️H in relation to DuraGen®️ at 60, 90 and 180 days post-surgery in patients who underwent dural surgery compared to day 30 post-surgery using the Barthel Index.

    To evaluate the safety of BIOSCAFF®️H in relation to DuraGen®️ using the Barthel Index, which consists of 10 questions to assess the patient's level of disability, with a minimum score of 0 and a maximum score of 100 indicating severe disability. The closer a subject's score is to 0, the more dependent he/she is; the closer to 100, the more independent he/she is.

    Measured: 180 days post-surgery

  3. Compare the quality of life in patients who underwent dural surgery and were implanted

    To compare the results of the SF-36 and EQ-5D-5L quality of life scales in dural surgery patients implanted with BIOSCAFF®H or DuraGen® on days 60, 90, and 180 postoperatively compared to day 30 postoperatively.

    The SF-36 is a self-administered instrument consisting of 36 questions. For each scale, the responses to each question are coded and recoded (10 questions), and the results are converted to a scale from 0 (worst health) to 100 (best health).

    The EQ-5D-5L scale is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic evaluation with five dimensions. The maximum value is 100, which represents the best health you can imagine, and the minimum value of 0 represents the worst health you can imagine. It should be used in conjunction with the EuroQol website.

    After applying both scales to the patients, the results are compared.

    Measured: 180 days post-surgery

  4. To evaluate the incidence of infection with BIOSCAFF®H at 30 days post-surgery compared to the active comparator and the safety of BIOSCAFF®H on the incidence of surgical site infections at 30, 60, 90 and 180 days post-surgery compared to DuraGen®.

    Frequency of surgical site infections at 30, 60, 90, and 180 days after surgery.

    Measured: 180 days post-surgery

  5. To evaluate the incidence of adverse events and serious adverse events for BIOSCAFF®H compared to DuraGen® from day 0 to week 52 after surgery.

    Adverse events and serious adverse events from day 0 through week 52 after surgery.

    Measured: 52 weeks post-surgery

Timeline

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

  1. First posted17 May 2024
  2. Study start3 Sep 2024
  3. Primary completion18 Feb 2025
  4. Study completion18 Feb 2025

Why it stopped: Sponsor decision.

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06419855
Sponsor's protocol ID
TOP-1122-IV
Status last verified
Feb 2025
First submitted
9 May 2024
Last updated
25 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rosen CL, Steinberg GK, DeMonte F, Delashaw JB Jr, Lewis SB, Shaffrey ME, Aziz K, Hantel J, Marciano FF. Results of the prospective, randomized, multicenter clinical trial evaluating a biosynthesized cellulose graft for repair of dural defects. Neurosurgery. 2011 Nov;69(5):1093-103; discussion 1103-4. doi: 10.1227/NEU.0b013e3182284aca.

    PubMed 21670715

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebrospinal Fluid Leakage, run by Top Health S.A.P.I DE C.V. at 4 sites in Mexico.

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 4 inclusion and 18 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: stopped early, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Mexico. 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.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision.). Results are not available in the source record.

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?

Incidence of cerebrospinal fluid leakage (time frame: 52 weeks post-surgery). 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 NCT06419855, 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 25 Feb 2025.

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