Randomized, two-arm, multicenter study to evaluate the safety and efficacy of Dura Sealant Patch in reducing CSF leakage following elective cranial surgery
- Conditions
- brain fluidCSF leakage10009720
- Registration Number
- NL-OMON52748
- Lead Sponsor
- Polyganics BV, Groningen
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 26
Preoperative
1. Subjects who are able to provide written informed consent prior to
participating in the clinical investigation.
2. Subjects who are >= 22 years old.
3. Subjects who are able to comply with the follow-up or other study
requirements.
4. Subjects wo are planned for elective surgery including a trepanation to
reach the subdural infratentorial space (with lower limit of incision defined
as the lower edge of C2) in whom a dural incision will be closed.
5. Female subjects of child bearing potential must agree to use a form of
contraception from the time of signing the informed consent form through 90
days post-surgery.
Intraoperative
1. Subjects with surgical wound classification Class I/Clean.
2. Subjects with minimally 5 mm of dural space surrounding dural opening.
Preoperative
1. Female subjects who are pregnant or breastfeeding.
2. Subjects with an assumed impaired coagulation due to medication or otherwise.
3. Subjects with presence of an infection.
4. Subjects with any type of dural diseases in planned dural closure area.
5. Subjects requiring re-opening of planned surgical area within 90 days after
surgery.
6. Subjects with a known allergy to any of the components of LIQOSEAL®
(Lactide-Caprolactone co-polyester; Butanediol-BDI co-polyurethane;
Polyethylene glycol Succinimidyl Gluterate; Disodium hydrogen phosphate or D&C
Green No 6), DuraSeal and Adherus.
7. Subjects who previously received a LIQOSEAL®, DuraSeal or Adherus.
8. Subjects who previously participated in this study or any investigational
drug or device study within 30 days of screening.
9. Subjects with a presence of hydrocephalus.
10. Subjects with contra-indication to MRI [cardiac pacemaker or defibrillator,
severe claustrophobia, injured by a metallic object that was not removed,
cochlear (ear) implants, metallic implants [e.g. knee replacement].
Intraoperative
1. Subjects in whom elevation of PEEP has a potential detrimental effect.
2. Subjects who will require a CSF drain, electrodes or other devices passing
the dural layer or extra to intracranial bypass surgery.
3. Subjects who have primary closure of the dura mater with non-autologous
material.
4. Subjects in whom no intra-operative CSF leakage is present after primary
closure of the dura mater with elevation of PEEP.
5. Subjects who after primary closure (including galea, if applicable) of the
dura mater have a gap > 3 mm.
6. Subjects whose dural opening size including
5 mm margin exceeds patch size (8 x 8 cm).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is a composite endpoint defined as successful dural repair<br /><br>without any of the following through 90 days following surgery compared to the<br /><br>control group:<br /><br><br /><br>• Intra-operative CSF leak (1)<br /><br>• Percutaneous CSF leak (2)<br /><br>• Significant pseudomeningocele (3)<br /><br>• incidence of pseudomeningocele >20 cc as confirmed on MRI<br /><br>* Wound infection (4)<br /><br><br /><br>(1) after device application and Positive End Expiratory Pressure (PEEP)<br /><br>(2) confirmed by β-2 transferrin test or by any additional intervention as<br /><br>assessed by treating physician<br /><br>(3) with the need of puncture, external lumbar drainage or surgical evacuation<br /><br>as assessed by treating physician<br /><br>(4) Deep incisional, Organ or space infections (according to SSI<br /><br>classification)</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Incidence of pseudomeningocele as confirmed on MRI at Day 90<br /><br>• Volume of pseudomeningocele as determined on MRI at Day 90<br /><br>• Ease of use and application of LIQOSEAL®<br /><br>• Incidence of complications requiring a surgical re-intervention up to 30 days<br /><br>after surgery<br /><br><br /><br>Safety endpoint<br /><br>• Incidence of device related (S)AEs throughout the study up to 90 days after<br /><br>surgery</p><br>