Comparing the efficacy of using a Passive drain versus Clamped drain in reducing postoperative complications following Decompressive Craniectomy in traumatic brain injury patients - A Randomised Controlled Trial

This randomized controlled trial titled “Comparing the efficacy of Passive drain versus Clamped drain in reducing postoperative complications following Decompressive Craniectomy in traumatic brain injury patients” will be conducted at AIIMS Patna to address the ongoing controversy regarding routine drain use after decompressive craniectomy (DC). Traumatic brain injury (TBI) is a major cause of morbidity and mortality, and although DC is effective in controlling raised intracranial pressure, postoperative complications such as subgaleal hematoma, surgical site infection, hydrocephalus, and need for reoperation remain frequent. While passive drains are traditionally used, they may increase risks without improving functional outcomes, and no clear guidelines exist regarding their use or clamping. The study will enroll 94 adult patients (18–65 years) with isolated TBI requiring DC, randomized equally into two groups: passive drain versus clamped drain. Block randomization with sealed envelopes will ensure allocation concealment. Standardized DC will be performed in all cases, with drains removed on the second postoperative day if imaging is satisfactory; in the clamped group, drains will remain closed unless neurological deterioration occurs. Outcomes assessed will include postoperative complications, mortality, and 3-month neurological status using the Glasgow Outcome Scale–Extended. Data will be analyzed using appropriate statistical tests with p < 0.05 considered significant. We expect that clamped drains will be as safe as passive drains while minimizing infection and hydrocephalus risk, thereby contributing evidence to inform clinical practice, optimize outcomes, and guide future recommendations.