Treatment Approaches for Therapy-Associated Mucosal Lesions in Pediatric Oncohematology Patients: Findings from a Retrospective Observational Study in an Italian Pediatric Hospital.

Background/Objectives: To describe therapy-associated oral stomatitis and perianal mucosal lesions in pediatric oncohematology patients and compare healing time according to the treatment approach used in routine clinical practice. Methods: This retrospective observational study was conducted at Meyer Children's Hospital, Florence, Italy. Electronic health records of patients admitted to the Oncology or Bone Marrow Transplantation units between 1 January and 31 December 2024, were screened. Eligible patients were aged 0 to 18 years and had documented oral stomatitis and/or perianal mucosal lesions with sufficient clinical and nursing documentation to determine lesion localization, treatment, clinical evolution, and healing time. Demographic, clinical, pharmacological, nutritional, and nursing variables were extracted. Oral mucositis severity was classified using the World Health Organization Oral Toxicity Scale. Results: Among 525 screened records, 89 eligible patients aged 5 months to 18 years were included in the final analysis. Lesions were distributed across three mutually exclusive categories: oral-only (39.3%), perianal-only (42.7%), and combined oral-perianal involvement (18.0%). Most oral cases were grade 2 to 4. Oral stomatitis treated with Mucosamin® Spray healed faster than conventional therapy (3.5 ± 0.8 vs. 6.7 ± 1.1 days; mean difference, -3.21 days; 95% CI, -3.75 to -2.67; p < 0.001). Perianal fissures treated with Mucosamin® Rectal Gel also showed a shorter healing time than conventional therapy (3.4 ± 0.8 vs. 6.1 ± 0.8 days; mean difference, -2.76 days; 95% CI, -3.30 to -2.21; p < 0.001). Conclusions: Mucosamin® Spray and Rectal Gel were associated with shorter documented healing times than conventional approaches in this real-world pediatric cohort. These findings should be interpreted as preliminary and confirmed in controlled prospective multicenter studies.