Status:
COMPLETED
Hemopatch Safety and Efficacy Evaluation Versus Standard Practice for Sealing the Dura in Cerebrospinal Fluid Leaks
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Conditions:
Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Posterior fossa surgeries are generally complicated by difficulties in creating a watertight dural closure, which often requires the use of dural substitutes. In particular, surgical procedures at thi...
Detailed Description
Various techniques have been developed to overcome this problem and achieve a tight dural closure. Although there is published evidence showing the efficacy and safety of some of these sealants in pos...
Eligibility Criteria
Inclusion
- Patients who are planned for non-traumatic posterior fossa surgery
- Surgery that requires opening and closing of the dura mater.
- Patients who have a clean surgical wound (class I surgical wound classification)
- Patients undergoing one of the following surgical procedures:
- Space occupant injuries (LOEs) rese dried through the following approaches:
- Approaching the rear pit of the middle line
- Approach to the posterior paramedian fossa
- Approach to the cerebellar pontine angle (PC) and the back of the petrous vertex
- Clinical diagnosis of primary Chiari 1 (CM1) malformation and scheduled decompression surgery, with evidence of NM of tonsil herniation down by an independent official radiology report.
- Subjects who are able to provide written informed consent prior to participating in the clinical trial.
- Be over 18 years of age.
- Understand the purpose of the study and be available for frequent hospital visits.
- Women of childbearing potential and males with partners of childbearing potential should commit to using a highly effective method of contraception (such as surgical sterilization, double barrier method, oral contraceptives or contraceptive hormonal implants) and to continue to use them for up to 6 months after surgery.
Exclusion
- Patients undergoing a supratentorial surgical procedure/approach.
- Patients undergoing any other approach/surgical procedure at the base of the skull that is not in the posterior pit:
- Side boarding of the foramen magno: far side, extreme side, anterolateral, posterolateral,
- Approaching the jugular foramen: infratemporal, condylar juxta, transjugular
- Approach to the middle pit: subtemporal (+/-petrous apex perforation), pterional approach (any temporary fronto approach +/- orbitozygomatic replacement)
- Approach to the previous pit: subfrontal (uni or bilateral)
- Presence of hydrocephalus not resolved prior to surgery
- Previous surgery in the posterior pit.
- Pre-radiation therapy treatment.
- Previous (within the last 6 months) or anticipated neurosurgical procedure involving the opening of the dura mater that may affect the safety assessment
- \> 1 dural opening
- Inability to understand informed consent or unwillingness to participate in the study.
- Inability, at the time of consent, to return for follow-up evaluations after surgery
- Evidence of spinal dysraphism.
- Allergy, hypersensitivity or history of allergic reaction to Hemopatch or its components (to bovine proteins or bright blue dye: FD\&C blue No. 1 \[blue 1\]).
- Evidence of an infection within 5 days prior to the start of the study.
- Pregnancy or planning to become pregnant during the course of the study. Breast feeding
Key Trial Info
Start Date :
November 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2024
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT04419597
Start Date
November 2 2020
End Date
July 15 2024
Last Update
July 16 2024
Active Locations (1)
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1
Hospital Ramón y Cajal
Madrid, Spain, 28034