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

Launched by TOP HEALTH S.A.P.I DE C.V. · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of a new material called BIOSCAFF®H compared to an existing product called DuraGen® for repairing the dura mater, which is a protective layer around the brain. The study focuses on patients who have had cranial surgery and are at risk of cerebrospinal fluid leaks, which can happen after such procedures. Researchers will follow participants for 30 days after their surgery to see if either material helps prevent leaks or other complications.

To join the trial, participants need to be adults aged 18 to 70 who are undergoing specific types of brain surgery. They must be able to give informed consent and have a surgical incision of at least 2 cm. However, certain conditions like infections, recent surgeries at the same site, or serious health issues would disqualify them. Participants can expect to receive one of the two materials during their surgery and will be monitored for any symptoms or complications afterward. This study aims to find out if the new material works just as well as the current standard.

Gender

ALL

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.

Trial Officials