Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage following Elective Cranial Surgery: The Encase Trial

Background: Cerebrospinal fluid (CSF) leakage is one of the most common neurosurgical complications, occurring in 4 to 32% of surgical cases, with a higher incidence in complicated skull base surgery. We developed a Dural Sealant Patch (DSP, [Fig. 1]) for watertight dural closure after cranial surgery. This is a novel design with strong preclinical data supporting immediate watertight bonding to dura without a liquid component/spray.

Objective: To clinically study for the first time the safety and performance of the DSP as a means of reducing CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure.

Methods: We conducted an open-label, single-arm, multicenter study with a 360-day (12-month) follow-up ([Fig. 2]) A total of 40 patients were enrolled at three sites. The combined primary endpoint was defined as an occurrence of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H₂O, or postoperative wound infection. Overall statistical success was defined as a primary endpoint in 7% or less.[1] The secondary endpoints were pseudomeningocele and thickness of dura + DSP on MRI. Additionally reinterventions within 30 days and user satisfaction was analyzed.

Registry: Clinicaltrials.gov, NCT03566602.

Results: No patients met the primary endpoint. There were two incidences of self-limiting pseudomeningocele as confirmed on MRI. Thickness of dura and DSP were 3.5 mm ± 2.0 at day 7 and 2.1 mm ± 1.2 at day 90. No reinterventions were performed and users reported a satisfactory design and intuitiveness.

Discussion: DSP seems safe, shows adequate clinical performance and does not swell. As a next step, a randomized controlled trial against the best current practice will follow to further evaluate if DSP reduces CSF leakage while its safety is noninferior.

Fig. 1 Dura Sealant Patch.

Fig. 2 Study scheme.

Note: Dura Sealant Patch is commercially available as LIQOSEAL in Europe since January 2020, CE certificate no. 2030288CE06.

No conflict of interest has been declared by the author(s).

• Reference

• 1 van Doormaal TPC, Germans MR, Sie M. et al. Single-arm, open-label, multicenter study to evaluate the safety and performance of dura sealant patch in reducing cerebrospinal fluid leakage following elective cranial surgery: the ENCASE Trial Study Protocol. Neurosurgery 2020; 86 (02) E203-E208

Publication History

Article published online:
12 February 2021