Sandwich dural reconstruction versus conventional artificial dural patch repair for watertight closure after supratentorial craniotomy: study protocol for a randomized controlled trial

Achieving watertight dural closure after craniotomy remains technically challenging because of dural retraction and tissue defects. Conventional artificial dural substitutes may fail to achieve a reliable seal and can lead to postoperative complications such as subcutaneous fluid collection, cerebrospinal fluid (CSF) incisional leakage, and postoperative pneumocephalus. To address these limitations, we developed a novel sandwich dural reconstruction technique designed to improve sealing efficiency and reduce postoperative complications. This study aims to evaluate the efficacy and safety of this technique in patients undergoing supratentorial craniotomy. This prospective, single-center, parallel-group randomized controlled trial will enroll 244 patients undergoing supratentorial craniotomy. Participants will be randomly assigned in a 1:1 ratio to either the sandwich dural reconstruction group or the conventional artificial dural patch repair group. The primary outcome is postoperative incisional CSF leakage within 30 days after surgery. Secondary outcomes include postoperative subcutaneous fluid collection, postoperative pneumocephalus, surgical site infection, duration of dural reconstruction, and length of hospital stay. Outcome assessors and statisticians will remain blinded to group allocation. Participants will be followed for 3 months postoperatively. This randomized controlled trial will provide clinical evidence regarding the effectiveness and safety of the sandwich dural reconstruction technique for achieving watertight dural closure after supratentorial craniotomy. If proven effective, this technique may offer a practical strategy to reduce postoperative wound-related complications and improve surgical outcomes. Chinese Clinical Trial Registry (ChiCTR), http://www.chictr.org.cn ; ChiCTR2400091344. Registered on 26 October 2024.