Pilot study to assess the safety and efficacy of human acellular dermal matrix for Chiari surgery.

Abstract

Purpose: Although there may be benefits to adult patients who have had Chiari surgery when duroplasty is indicated, there are also more risks involved. The complications derived from a non-hermetic dural closure in the posterior fossa can be significant, mainly cerebrospinal fluid (CSF) leakage, meningitis and pseudomeningocele. We explored the option of utilizing a different duroplasty that we typically utilized in order to reduce these risks. The aim of this study is to assess the safety and efficacy of two duraplasties used for Chiari malformation (ChM) surgery: Tutopatch®, and a human acellular dermal matrix (hADM). Tutopatch®, a well-known collagen membrane commonly used by our senior surgeon, and hADM, prepared by the tissue establishment and with potential properties for use as duraplasty.

Methods: A unicentric prospective study was designed with one group of patients treated with hADM and another group that retrospectively acquired surgical treatment with Tutopatch®. There were nineteen patients in each group. The patients in both groups were diagnosed with same pathology and were operated on by the same senior surgeon. This study was approved by the same hospital's Medical Ethics Committee. Demographics, clinical risk factors, clinical syndrome and pre/postoperative and postoperative events after surgery were analysed. All serious adverse events (SAEs) and adverse events (AEs) after surgery were recorded.

Results: No differences were found between the two groups related to sex, clinical risk factors, clinical syndrome and clinical outcomes. Seven patients presented with complications, seven the Tutopatch® group (two of them requiring a new reoperation) and none in the hADM group.

Conclusion: This pilot study shows that hADM is a safe and effective alternative to Tutopatch® duraplasty, as although the two materials performed equally well in the surgical repair of Chiari malformation, the former showed better clinical outcomes. Future studies are needed to confirm these outcomes in larger cohorts.