Clinical efficacy and safety analysis of xenogeneic acellular dermal matrix in repairing ear skin defects: a single-center prospective study

BACKGROUND: Surgical management of chronic ear diseases, particularly middle ear cholesteatoma and chronic otitis media, often results in significant skin defects in the external auditory canal (EAC) and auricular region. OBJECTIVES: To evaluate the clinical efficacy and safety of xenogeneic acellular dermal matrix (xeno-ADM) in repairing ear skin defects following surgical resection of middle ear pathologies. MATERIAL AND METHODS: A prospective cohort study was conducted from March 2024 to April 2025 at a single tertiary care center. One hundred and twelve consecutive patients with ear skin defects underwent reconstruction using xeno-ADM. Primary outcomes included epithelialization time, functional recovery (ear canal patency, hearing improvement), and postoperative complications. Secondary outcomes included surgical difficulty, patient satisfaction, and physician evaluation. Air conduction threshold changes were measured pre- and postoperatively. Pain was assessed using Visual Analog Scale. RESULTS: Mean epithelialization time was 36.0 days. All patients achieved complete epithelialization with 100% ear canal patency. Hearing improved significantly with mean air conduction threshold reduction of -13.32 ± 14.67 dB, with 94% of patients showing improvement or stability. Postoperative pain was minimal. Complications were rare: mild exudate in 75.0%, local infection in 0.9%, partial membrane loss in 13.4% (successfully managed with reapplication). No rejection reactions occurred. Patient satisfaction was 100% for both appearance and function. CONCLUSIONS AND SIGNIFICANCE: Xeno-ADM demonstrates excellent efficacy and safety for ear skin defect repair, offering rapid epithelialization, significant hearing improvement, minimal pain, and high patient satisfaction during the mean follow-up of 6 months. However, the absence of a control group limits the strength of these conclusions, and long-term outcomes remain unknown due to the limited follow-up duration.