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

NCT06419855 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2025-02-25

No results posted yet for this study

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 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.

Conditions

  • Cerebrospinal Fluid Leakage

Interventions

DEVICE

Human collagen matrix graft

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.

DEVICE

Bovine collagen matrix graft

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.

Sponsors & Collaborators

  • CLINICAL RESEARCH PS MEXICO

    collaborator UNKNOWN

  • Top Health S.A.P.I DE C.V.

    lead INDUSTRY

Principal Investigators

  • Juan P. Aguilar Alemán, PhD · Top Health S.A.P.I DE C.V.

  • Beni Camacho Perez, PhD · Top Health S.A.P.I DE C.V.

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-03
Primary Completion
2025-02-18
Completion
2025-02-18

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06419855 on ClinicalTrials.gov