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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Incidence of cerebrospinal fluid leakage
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of cerebrospinal fluid leakage
时间窗: 52 weeks post-surgery
To evaluate effectiveness of BIOSCAFF®️H graph in patients who underwent dural surgery on the incidence of cerebrospinal fluid leakage versus an active comparator
次要结局
- 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 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)
- 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)