Hemopatch Safety and Efficacy Evaluation Versus Standard Practice for Sealing the Dura in Cerebrospinal Fluid Leaks

NCT04419597 | Completed

• 1 other identifier: NEUROHEMOPATCH
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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 this location are associated with an increased rate of fluid leakage (cerebrospinal fluid (CSF)) or inflow (blood, air, etc.) creating hydrodynamic complications. Effective sealing of the dura is required to prevent such complications and infections by minimizing the introduction of irritating blood products into the CSF. Since true hermetic dural seals are often impossible to achieve, dural sealants have been developed that can be applied to the sutured dural perimeter to help prevent complications related to CSF. Adjuvant use of such sealants may be prudent, particularly in posterior fossa surgeries, as the incidence of CSF leakage has been reported to be as high as approximately 15-28% with such surgeries, with an increased risk of leakage. 5.84 times greater than supratentorial procedures.

Conditions

Surgery

Keywords

Posterior fossa; HEMOPATCH; cerebrospinal fluid (CSF); CSF leak

Outcome Measures

Primary Outcomes (1)

• proportion of participants with clinically evident CSF leak after the operation up to 4 weeks.

  Clinically evident CSF leak, observed from the operation to 4 weeks later. It will be measured every 24 hours until the patient is discharged. The following measurement will be made at the visit of the 4 weeks (+/- 7 days) from the operation

  4 weeks

Secondary Outcomes (5)

• Proportion of participants with clinical pseudomeningocele or evident MRI

  6 months

• Proportion of participants with ascent of the cerebellar tonsils

  6 months

• Proportion of participants with readmissions related to CSF leaks

  4 weeks

• Number of Participants with Surgical site infections (SSI)

  4 weeks

• Assessment of quality of life (QoL): SF12 questionnaire (Short Form 12 questionnaire)

  6 months

Study Arms (2)

HEMOPATCH Collagen Patch and PEG Haemostatic Sealant

EXPERIMENTAL

Two units of the large patch are applied as reinforcement of the primary dural seal (HEMOPATCH 4,5x9cm, 1506253).

Device: HEMOPATCH

Standard of care treatment

ACTIVE COMPARATOR

Usual clinical practice techniques for reinforcing primary dural closure.

Device: Standard of care

Interventions

HEMOPATCH DEVICE

The treatment will be performed with the HEMOPATCH collagen patch and hemostatic PEG sealant (Baxter), applying two units of the large patch to reinforce the primary dural closure (HEMOPATCH 4.5x9cm, 1506253).

HEMOPATCH Collagen Patch and PEG Haemostatic Sealant

Standard of care DEVICE

Usual clinical practice techniques for reinforcing primary dural closure.

Standard of care treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \[blue 1\]).

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Cerebrospinal Fluid Otorrhea

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 5, 2020
• Study Start: November 2, 2020
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)