A Randomized Controlled Trial Comparing Subcutaneous Preservation of Bone Flaps with Cryogenic Preservation of Bone Flaps for Cranioplasty in Cases of Traumatic Brain Injury.

BACKGROUND AND OBJECTIVES

Decompressive craniectomy (DC) is a surgical procedure, useful for relieving the intracranial pressure following trauma. Following reduction in cerebral oedema, the bone is placed back to cover the defect. During the interim period, the bone flap may be preserved using cryopreservation or in subcutaneous tissue. This leads to a need to determine the benefits and risks involved in preservation of bone flap in a subcutaneous pocket or conventional freezer following decompressive craniectomy in traumatic brain injury.

MATERIALS AND METHODS

An open randomized controlled trial was conducted at a level one trauma centre from July 2023 to December 2024. Simple randomization was performed in order to allocate patients into the subcutaneous preservation group and the cryogenic preservation group. Patients underwent cranioplasty after 3 months and were followed up post-operatively for complications and Glasgow Outcome Scale assessment.

RESULTS

The study initially recruited a total of 158 patients, out of which 104 patients remained eligible for the final analysis. The patients with cryopreserved flaps were found to have a higher rate of surgical site infection (31.3%) as compared to those with subcutaneously preserved flaps (5.6%), with the differences being statistically significant ( < 0.001). Among the 87 patients who had a poorer Glasgow Outcome Scale (GOS) score before the intervention, 55 (63.2%) patients had at least some improvement in GOS over a period of one month.

CONCLUSION

The use of subcutaneous preservation of bone is more beneficial in resource-limited settings as compared to conventional freezer storage.