How to Assemble and Apply DuraSeal® Dural Sealant System

In almost all types of surgeries, innovations in sealants have introduced adjuncts to sutures and staples for surgical wound closure. These sealants have the added benefit of preventing leakages during and after surgery. This is particularly essential in neurosurgery, because if a watertight dural closure is not achieved, cerebrospinal fluid could leak and associated complications may occur.

The DuraSeal® Dural Sealant System is a polyethylene glycol hydrogel intended for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure.

It is designed for tissue adherence and cohesive strength to withstand critical pressures, has a distinct blue color for better visualization, and can form a watertight seal in seconds.^[1]

Watch the below for a step-by-step guide to assembling the standard kit for DuraSeal® Dural Sealant System:

Watch the below for a surgical video of DuraSeal® used in a parietal tumor resection:

For application and use of the extended tip and MicroMyst® Applicator, download the poster here.

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^[1] Campbell PK. et al. Evaluation of Absorbable Surgical Sealants. In vitro Testing LT-6000-016 Rev. Confluent Surgical, Inc., Waltham, MA 02451, 2005.

INDICATION:
The DuraSeal® Dural Sealant System is intended for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure.

CONTRAINDICATIONS:
Do not apply the DuraSeal® hydrogel to confined bony structures where nerves are present since neural compression may result due to hydrogel swelling. The hydrogel may swell up to 50% of its size in any direction.

SAFETY RESULTS:
Pre-Market Approval Study: All 111 patients treated with the DuraSeal® Sealant showed no leakage during the intra-operative assessment. 109 of 111 patients (98.2%) met the criteria for primary endpoint success; i.e., intraoperative sealing. The incidence of post-op CSF leaks in this study was 4.5%. Of these leaks, 1.8% were incisional and 2.7% were pseudomeningoceles.

Post–Market Approval Study: There were three CSF leaks reported during the course of this study, including one in the DuraSeal® group and two in the Control group (0.8% DuraSeal® vs 1.7% Control, p=0.619). The reported leak rate did not show a significant difference between groups. The incidence and nature of adverse events observed in both the pre and post-market study populations are consistent with the type and complexity of the surgery performed and the co-morbid state of the treated patients. Please see DuraSeal® Instructions for Use for more information.