Efficacy and Safety Analysis of More Stable Foam and Ordinary Foam Based on Polylauricol in the Treatment of Head and Neck Venous Malformations: a Prospective, Randomized and Controlled Study

What this Trial Is About

This research aims to evaluate the effectiveness and safety of a more stable poly(cinnamyl alcohol) foam compared to ordinary foam in treating venous malformations of the head and neck. Venous malformations are abnormal blood vessel formations, and foam sclerotherapy has become a widely used method for treatment. This trial is designed as a prospective, randomized clinical study to provide clearer evidence and better treatment options for these malformations. The study compares two types of foam treatments produced by mixing a 1% poly(cinnamyl alcohol) solution with air using Tessari's method. One foam type includes 0.05% hyaluronic acid, making it more stable with a longer half-life than the ordinary foam. Treatments are injected into the venous malformations to displace blood and maintain contact with vessel walls, potentially enhancing therapeutic effects. The trial assesses whether this increased stability improves treatment outcomes and safety. Participants aged 14 to 60 years with diagnosed head and neck venous malformations will receive foam injections and be monitored over 3 to 4 weeks after treatment. Researchers will measure the remission rate, lesion volume, and number of injections needed. Safety and efficacy evaluations will be conducted during follow-up visits, with treatment repeated as necessary based on condition. The study's total duration extends until June 2026, ensuring thorough assessment of treatment results and participant well-being.

Efficacy and Safety Analysis of Polylauric Alcohol More Stable Foam Versus Ordinary Foam in the Treatment of Head and Neck Venous Malformations