Clinical trial NCT06419855: Study to Evaluate the Effectivity and Safety of BIOSCAFF®H Compared to DuraGen®, in Patients Undergoing Dural Repair
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cerebrospinal Fluid Leakage
Keywords: Dural surgery
Sealing
Leakage
Cerebrospinal fluid
Collagen matrix graft
Dura
Lead sponsor: Top Health S.A.P.I DE C.V.
Sponsor class: INDUSTRY
Collaborators: name: CLINICAL RESEARCH PS MEXICO
First posted: 2024-05-17
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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%.
* Patients in whom radiological contrast medium is contraindicated.
* Women who are breastfeeding or pregnant.
* Patients with a body mass index (BMI) ≥ 35 kg/m2.

Primary outcomes:
measure: Incidence of cerebrospinal fluid leakage
timeFrame: 52 weeks post-surgery
Secondary outcomes:
measure: 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).
timeFrame: 180 days post-surgery
measure: 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.
timeFrame: 180 days post-surgery
measure: Compare the quality of life in patients who underwent dural surgery and were implanted
timeFrame: 180 days post-surgery
measure: 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®.
timeFrame: 180 days post-surgery
measure: 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.
timeFrame: 52 weeks post-surgery
Other outcomes:
measure: 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®.
timeFrame: 180 days post-surgery
measure: To evaluate wound healing 180 days after surgery
timeFrame: 180 days post-surgery
Locations:
city: Guadalajara
country: Mexico
facility: CIMeT Scientific Corporation S.A.P.I. DE C.V.
state: Jalisco
city: Zapopan
country: Mexico
facility: Investigación Biomédica para el Desarrollo de Fármacos S.A de C.V.
state: Jalisco
city: San Luis Potos
country: Mexico
facility: Bind Investigaciones S.C.
city: Veracruz
country: Mexico
facility: Faicic S. de R.L. de C.V.
Study officials:
affiliation: Top Health S.A.P.I DE C.V.
name: Juan P. Aguilar Alemán, PhD
role: STUDY_DIRECTOR
affiliation: Top Health S.A.P.I DE C.V.
name: Beni Camacho Perez, PhD
role: STUDY_DIRECTOR
References:
citation: 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.