NCT06419855

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Top Health S.A.P.I DE C.V. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cerebrospinal Fluid Leakage

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-03
• Primary completion: 2025-02-18
• Completion: 2025-02-18
• First posted: 2024-05-17
• Last updated: 2025-02-25

Locations

4 sites across 1 country: Mexico