Evaluate the safety and efficacy of dura sealant patch in reducing cerebrospinal fluid leakage following elective cranial surgery (ENCASE II): study protocol for a randomized, two-arm, multicenter trial.

BACKGROUND: Cerebrospinal fluid (CSF) leakage is a frequent and challenging complication in neurosurgery, especially in the posterior fossa, with a prevalence of 8%. It is associated with substantial morbidity and increased healthcare costs. A novel dural sealant patch (LIQOSEAL) was developed for watertight dural closure. The objective of this study is to clinically assess the safety and effectiveness of LIQOSEAL as a means of reducing intra- as well as postoperative CSF leakage in patients undergoing elective posterior fossa intradural surgery with a dural closure procedure compared to the best currently available dural sealants. METHODS: We will conduct a two-arm, randomized controlled, multicenter study with a 90-day follow-up. A total of 228 patients will be enrolled in 19 sites, of which 114 will receive LIQOSEAL and 114 an FDA-approved PEG sealant. The composite primary endpoint is defined as intraoperative CSF leakage at PEEP 20 cm H2O, percutaneous CSF leakage within 90 days of, wound infection within 90 days of or pseudomeningocele of more than 20cc on MRI or requiring intervention. We hypothesize that the primary endpoint will not be reached by more than 10 patients (9%) in the investigational arm, which will demonstrate non-inferiority of LIQOSEAL compared to control. DISCUSSION: This trial will evaluate whether LIQOSEAL is non-inferior to control as a means of reducing CSF leakage and safety TRIAL REGISTRATION: ClinicalTrials.gov NCT04086550 . Registered on 11 September 2019.

Pediatric concussions in sports; a simple and rapid assessment tool for concussive injury in children and adults.

BACKGROUND: We established a routine protocol for concussion evaluation in athletes for nonmedical personnel. The evaluation, management guidelines, and return-to-play recommendations were summarized with a memorable mnemonic on a convenient handheld card. MATERIALS AND METHODS: The ability to remember the return-to-play mnemonic and effectively apply it to corresponding guidelines was evaluated in 194 sports personnel without medical training. The participants were given three clinical scenarios, each including age, pertinent history, sporting event, description of an injury, symptoms, signs, and a brief neurological exam. Subsequently, the subject's ability to recall the return-to-play mnemonic and the Standard Assessment of Concussion, to describe the corresponding guidelines, and to advise return-to-play was evaluated. CONCLUSION: Our "return-to-play" mnemonic was found to be simple and memorable, allowing for a high recall percentage and accurate evaluation of concussion cases. High intersubject agreement suggests that this method has both standardization and generalization potential.