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.
Age 14-60 years of age, sex unlimited (except pregnant women or those preparing for pregnancy)
Clinical diagnosis and imaging () were consistent with head and neck venous malformations
Participants volunteered to participate in the trial and signed an informed consent form.
People with serious systemic diseases, including heart disease, high blood pressure, diabetes, etc. , that are not under control. Heart Attack: 1. Recent frequent attacks of angina. 2. Recent history of myocardial infarction 3. Cardiac function grade iii-iv or with symptoms of sitting breathing, cyanosis, jugular venous distension, lower limb edema, etc. . 4. Heart disease complicated with hypertension 5. Type II or III Type II atrioventricular block, double bundle branch block, as syndrome, diabetes: blood sugar control in 8.88 mmol/L above, hypertension: after taking medicine blood pressure can not be controlled in the normal range namely systolic pressure below 140 mmhg, diastolic pressure below 90 mmhg)
Patients who are unable to follow up on time;
Persons who are mentally ill or have mental disorders;
The patient or his/her authorized person is unwilling to sign a written informed consent or comply with the protocol
Parallel
The addition of sodium hyaluronate to poly (cinnamyl alcohol-RRB- produces a more stable foam
Combination productAccording 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.
Remission rate of venous malformations in head and neck
Patients were satisfied and no further treatment was needed after clinical evaluation. This was the last treatment. The proportion of patients who responded to treatment was counted and compared between the two groups.
Volume of venous malformation
The volume changes of venous malformations were compared before and after treatment. The patients were examined by MRI before operation and after the last treatment
Foam injection
The total foam volume from the first treatment to the end of treatment was recorded.
Number of treatment
Statistics of patients with the first treatment to the last treatment of the total number of treatments.
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