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RECRUITING
NCT07066527
NA

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

Sponsor: Qilu Hospital of Shandong University

View on ClinicalTrials.gov

Summary

The aim of this study is to explore the efficacy and safety of poly -LRB-cinnamyl alcohol) foam in the treatment of venous malformations of head and neck through a prospective randomized clinical trial, this trial may provide better treatment options and evidence for head and neck VMs.

Official title: 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

Key Details

Gender

All

Age Range

14 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2022-06-01

Completion Date

2026-06-30

Last Updated

2025-07-15

Healthy Volunteers

Yes

Interventions

COMBINATION_PRODUCT

The addition of sodium hyaluronate to poly (cinnamyl alcohol-RRB- produces a more stable foam

According to the study, the half-life of 1% poly (cinnamyl alcohol-RPol(POL) foam with a liquid-to-gas ratio of 1:4 was 142.8(64.32) seconds, in this study, the half-life of the foam made from 1% POL containing 0.05% hyaluronic acid (HA) was 390.4(613.06) seconds, human blood contains a certain amount of HA, according to the literature reported that 0.05% concentration of HA injected into human blood is safe, so this more stable foam preparation method was patented, and published in international journals.

Locations (1)

Shandong University Qilu Hospital

Jinan, Shandong, China