Outcomes of Intralesional Bleomycin Therapy in Low-Flow Vascular Malformations of the Head and Neck: Pain, Functional Improvement, and Patient Satisfaction from a Prospective Multi-Centre Study in Iraq

Abstract

Low-flow vascular malformations of the head and neck are congenital venous, lymphatic, and mixed lesions that cause pain, functional impairment, and psychosocial distress. Although bleomycin sclerotherapy is well established for reducing lesion volume, patient-reported outcomes such as pain relief, functional recovery, and overall satisfaction remain insufficiently documented, particularly in the Iraqi clinical setting. This prospective multi-centre study evaluated these outcomes in 20 patients with low-flow vascular malformations of the head and neck treated with intralesional bleomycin sclerotherapy across three Iraqi teaching hospitals between August 2025 and April 2026. Pain was assessed using the Visual Analog Scale or the Wong-Baker FACES scale, functional status was evaluated through clinician- and patient-reported assessment of speech, mastication, swallowing, and oral competence, and satisfaction was recorded on a five-point Likert scale four weeks after the final treatment. Pain scores decreased significantly, from a mean of 2.7 ± 2.4 at baseline to 0.9 ± 1.3 after treatment (p < 0.001; effect size r = 0.71), and 9 of the 16 patients with baseline pain (56.3%) achieved complete pain relief. All 17 patients with pre-treatment functional deficits (100%) reported meaningful improvement, and both patients with pre-treatment bleeding episodes achieved complete cessation of bleeding. The mean satisfaction score was 4.35 ± 0.99 out of 5, with 17 patients (85.0%) reporting satisfaction or high satisfaction, and no severe adverse events occurred. These findings indicate that intralesional bleomycin sclerotherapy produces clinically meaningful improvements in pain, function, and satisfaction in low-flow vascular malformations of the head and neck, supporting its role as an effective and patient-valued treatment option for these lesions.