1343 Prophylactic Use of Dural Tenting Sutures in Elective, Supratentorial Craniotomies in Adults—Is It Necessary? A Report of a Multi-Center, Investigator- and Participant-Blinded Randomized, Parallel-Group, Non-Inferiority Clinical Trial

INTRODUCTION: Dural tenting sutures are a well-known neurosurgical technique. However, their use in preventing extradural hematomas (EDHs) lacks evidence-based support. For that reason, we deemed it necessary to evaluate this technique in an evidence–based manner. METHODS: This is a report of a randomized, multi-center, investigator- and participant-blinded, controlled interventional non-inferiority trial with 1:1 allocation (NCT03658941). We included adults undergoing elective, supratentorial craniotomies. The primary outcome was the risk of reoperation due to EDH and secondary outcomes included other clinical and radiological outcomes. RESULTS: We randomized 490 patients into intervention (238, 49%, not tenting the dura) and control (252, 51%, dural tenting) study groups, as per intention-to-treat analysis. Proportions of EDH surgeries in intervention group were non-inferior in comparison to control group as well as not significantly different using the intention-to-treat (0.8% and 0.4%, p=0.98), per-protocol (0.5%, 0.4%, p=1) and as-treated (0.5%, 0.7%, p>0.99) analyses. There were no significant differences in secondary outcomes: postoperative 30-day mortality (0.8%, 1.2%, p=1), postoperative 30-day readmission (1.7%, 4.4%, p=0.99), new neurologic deficit or deterioration of a previous deficit (19.7%, 15.5%, p=0.81), cerebrospinal fluid leak (1.3%, 4.4%, p=1), deterioration of postoperative headache over 5 NRS (4.4%, 2.4%, p=0.85), epidural collection thickness over 3 mm (90.8%, 87.3%, p=0.81) and midline shift over 5 mm (7.6%, 4.8%, p=0.791) in intervention and control study groups as per an intention-to-treat analysis. Similarly, secondary outcomes were not different in per-protocol and as-treated analyses. Other than CSF leak and EDH, there were 17 adverse events in the intervention group and 19 in the control group, as per the intervention-to-treat analysis (7.1% and 7.5%, respectively). CONCLUSIONS: This trial demonstrates non-inferiority of omitting prophylactic dural tenting in terms of postoperative EDH requiring surgery in adults undergoing elective, supratentorial craniotomies.