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

NCT06419855 | Terminated

• 1 other identifier: TOP-1122-IV
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Dural surgery; Sealing; Leakage; Cerebrospinal fluid; Collagen matrix graft; Dura

Outcome Measures

Primary Outcomes (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

  52 weeks post-surgery

Secondary Outcomes (5)

• 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).

  180 days post-surgery

• 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.

  180 days post-surgery

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

  180 days post-surgery

• 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®.

  180 days post-surgery

• 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.

  52 weeks post-surgery

Other Outcomes (2)

• To evaluate the serum/plasma concentration of immunoglobulins IgG, IgE, IgM, IgA as possible indicators of immunogenicity in BIOSCAFF®H compared to those implanted with DuraGen®.

  180 days post-surgery

• To evaluate wound healing 180 days after surgery

  180 days post-surgery

Study Arms (2)

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: Human collagen matrix graft

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.

Device: Bovine collagen matrix graft

Interventions

Human collagen matrix graft DEVICE

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.

Human collagen matrix graft

Bovine collagen matrix graft DEVICE

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.

Bovine collagen matrix graft

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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%.

Sponsors & Collaborators

• Top Health S.A.P.I DE C.V.: lead
• CLINICAL RESEARCH PS MEXICO: collaborator

Study Sites (4)

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

Guadalajara, Jalisco, 44340, Mexico

Location

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

Zapopan, Jalisco, 45070, Mexico

Location

Bind Investigaciones S.C.

San Luis Potos, San Luis Potos, 78213, Mexico

Location

Faicic S. de R.L. de C.V.

Veracruz, Veracruz, 91900, Mexico

Location

Related Publications (1)

• 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.

  PMID: 21670715 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples

MeSH Terms

Conditions

Cerebrospinal Fluid Leak

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Juan P. Aguilar Alemán, PhD

  Top Health S.A.P.I DE C.V.

  STUDY DIRECTOR

• Beni Camacho Perez, PhD

  Top Health S.A.P.I DE C.V.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 17, 2024
• Study Start: September 3, 2024
• Primary Completion: February 18, 2025
• Study Completion: February 18, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (4)