Intralesional Bleomycin Sclerotherapy for Low-Flow Vascular Malformations of the Head and Neck | NCT07728825

NCT07728825

Overview

NCT ID: NCT07728825
Lead Sponsor: University Of AnbarOTHER
Official Title: Evaluation of the Efficacy of Intralesional Bleomycin Injections for the Treatment of Low-Flow Vascular Malformations: A Multi-Center Study in Iraq
Brief Summary: This study evaluated lesion volume reduction after intralesional bleomycin sclerotherapy in patients with low-flow vascular malformations of the head and neck, and identified predictors of treatment response. Twenty patients were enrolled across three Iraqi teaching hospitals and treated with intralesional bleomycin. Lesion volume was assessed by ultrasound or MRI at baseline and four weeks after the final treatment session.
Conditions: Vascular Malformations
Venous Malformation
Lymphatic Malformation

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Age older than one year

Clinically and radiologically confirmed low-flow vascular malformation of the head and neck

No prior bleomycin therapy

Medically fit for outpatient intervention

Exclusion Criteria:

High-flow vascular malformation

Pregnancy or lactation

Documented hypersensitivity to bleomycin

Pre-existing pulmonary or hepatic disease

Bleeding disorder or current anticoagulant use

Renal impairment (serum creatinine > 1.5 mg/dL or estimated glomerular filtration rate < 60 mL/min/1.73 m²)

Active infection at or near the treatment site