SurgeryNCT04419597
Hemopatch Safety and Efficacy Evaluation Versus Standard Practice for Sealing the Dura in Cerebrospinal Fluid Leaks
A study testing HEMOPATCH in people with Surgery, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- HEMOPATCH
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSpain
- Study dates
- 2 Nov 2020to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Multicenter Controlled Study to Evaluate the Safety and Efficacy of HEMOPATCH® Compared to Routine Care for Dural Closure as Reinforcement for the Prevention of Postoperative Cerebrospinal Fluid Leakage (CSF) in Patients Undergoing Posterior Fossa Surgery
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.
Read the 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 posterior fossa surgery, the different types of pathologies and various population risk factors included in these trials make it difficult to interpret the results. Having selective inclusion criteria and including patients with a selected pathology could be essential to obtain clearer results.
Postoperative CSF leak has two aspects: one is pseudomeningocele (a subcutaneous collection of CSF); the other is a CSF fistula in which CSF reaches the skin. This second one is much more dangerous and constitutes one of the most important complications of this surgery, but the pseudomeningocele is a clinical demonstration of failure of the dural closure.
HEMOPATCH is a soft, thin, foldable and flexible collagen patch, coated with NHS-PEG. HEMOPATCH is indicated as a hemostatic device and surgical seal for procedures in which control of bleeding or leakage of other body fluids or air by conventional surgical techniques is ineffective or impractical.
Preliminary clinical evidence collects a prospective case series of 200 patients, in which the authors reviewed the use of HEMOPATCH for dural augmentation in high-risk patients from 2014 to this year. After 2 years of refining the technique, a decrease in CSF leaks from 27% to 7% was achieved, and no adverse events related to the application of the product were observed. A retrospective cohort study has recently been published comparing the use of HEMOPATCH versus routine clinical practice in 290 patients, in which 147 used standard dural reinforcement techniques, and 143 used HEMOPATCH. The CSF fistula appearance rates were 7.69% in the HEMOPATCH group, compared to 32.65% in the control group.
These recent results, along with the characteristics and properties of the patch, could make this sealant a safe and plausible option to achieve sealing after posterior fossa surgery.
- Conditions
- Surgery
- Being tested
- HEMOPATCH, Standard of care
- Keywords
- Posterior fossa, HEMOPATCH, cerebrospinal fluid (CSF), CSF leak
- Medical subject headings
- Cerebrospinal Fluid Otorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEMOPATCHDevice
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).
Standard of careDevice
Usual clinical practice techniques for reinforcing primary dural closure.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: HEMOPATCH |
| Standard of care treatment | Active comparator | Usual clinical practice techniques for reinforcing primary dural closure. Receives: Device: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (5)
Proportion of participants with clinical pseudomeningocele or evident MRI
Clinical evidence of Pseudomeningocele or by imaging techniques, evaluated by CT or MRI during the 4 postoperative weeks, by MRI at 6 postoperative months, or at any visit of patients within 6 postoperative months according to the criteria of the investigator
Measured: 6 months
Proportion of participants with ascent of the cerebellar tonsils
The elevation of the cerebellar tonsils will be measured, according to the baseline preoperative CT / MRI, in the MRI test performed 6 months after the operation.
Measured: 6 months
Proportion of participants with readmissions related to CSF leaks
The need for readmission / reoperation related to CSF leak will be collected up to 4 weeks after the operation.
Measured: 4 weeks
Number of Participants with Surgical site infections (SSI)
Bacterial or chemical meningitis (SSI)
Measured: 4 weeks
Assessment of quality of life (QoL): SF12 questionnaire (Short Form 12 questionnaire)
The SF-12 measures overall quality of life and includes items that assess participation. The SF-12 is a frequently used measure and has shown to have good internal consistency, reliability, construct validity and responsiveness in patients with chronic (low) back pain (Luo et al., 2003). The measure is a subset of 12 items from the SF-36 including 6 items from the physical summary measure (PCS) and 6 items from the mental summary measure (MCS).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start2 Nov 2020
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419597
- Sponsor's protocol ID
- NEUROHEMOPATCH
- Status last verified
- Jul 2024
- First submitted
- 3 Jun 2020
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Controlled Study to Evaluate the Safety and Efficacy of HEMOPATCH® Compared to Routine Care for Dural Closure as Reinforcement for the Prevention of Postoperative Cerebrospinal Fluid Leakage (CSF) in Patients Undergoing Posterior Fossa Surgery
- ClinicalTrials.gov ID
- NCT04419597
- Acronym / sponsor ID
- NEUROHEMOPATCH
- Conditions
- Surgery
- Keywords
- Posterior fossa, HEMOPATCH, cerebrospinal fluid (CSF), CSF leak
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 posterior fossa surgery, the different types of pathologies and various population risk factors included in these trials make it difficult to interpret the results. Having selective inclusion criteria and including patients with a selected pathology could be essential to obtain clearer results.
Postoperative CSF leak has two aspects: one is pseudomeningocele (a subcutaneous collection of CSF); the other is a CSF fistula in which CSF reaches the skin. This second one is much more dangerous and constitutes one of the most important complications of this surgery, but the pseudomeningocele is a clinical demonstration of failure of the dural closure.
HEMOPATCH is a soft, thin, foldable and flexible collagen patch, coated with NHS-PEG. HEMOPATCH is indicated as a hemostatic device and surgical seal for procedures in which control of bleeding or leakage of other body fluids or air by conventional surgical techniques is ineffective or impractical.
Preliminary clinical evidence collects a prospective case series of 200 patients, in which the authors reviewed the use of HEMOPATCH for dural augmentation in high-risk patients from 2014 to this year. After 2 years of refining the technique, a decrease in CSF leaks from 27% to 7% was achieved, and no adverse events related to the application of the product were observed. A retrospective cohort study has recently been published comparing the use of HEMOPATCH versus routine clinical practice in 290 patients, in which 147 used standard dural reinforcement techniques, and 143 used HEMOPATCH. The CSF fistula appearance rates were 7.69% in the HEMOPATCH group, compared to 32.65% in the control group.
These recent results, along with the characteristics and properties of the patch, could make this sealant a safe and plausible option to achieve sealing after posterior fossa surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEMOPATCH Collagen Patch and PEG Haemostatic Sealant | Experimental | Device: HEMOPATCHTwo units of the large patch are applied as reinforcement of the primary dural seal (HEMOPATCH 4,5x9cm, 1506253). |
| Standard of care treatment | Active comparator | Device: Standard of careUsual clinical practice techniques for reinforcing primary dural closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEMOPATCHThe 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). | Device | HEMOPATCH Collagen Patch and PEG Haemostatic Sealant |
| Standard of careUsual clinical practice techniques for reinforcing primary dural closure. | Device | Standard of care treatment |
Primary outcome
proportion of participants with clinically evident CSF leak after the operation up to 4 weeks.
Time frame: 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
5 secondary outcomes
Proportion of participants with clinical pseudomeningocele or evident MRI
Time frame: 6 months
Proportion of participants with ascent of the cerebellar tonsils
Time frame: 6 months
Proportion of participants with readmissions related to CSF leaks
Time frame: 4 weeks
Number of Participants with Surgical site infections (SSI)
Time frame: 4 weeks
Assessment of quality of life (QoL): SF12 questionnaire (Short Form 12 questionnaire)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEMOPATCH in people with Surgery, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of participants with clinically evident CSF leak after the operation up to 4 weeks. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.