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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-60
SponsorQilu Hospital of Shandong University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

110 Participants
are divided into 2 treatment groups