Treatment of Venous Malformation

Treatment of Venous Malformation by Direct Puncture Repair: Ethanol Versus Polidocanol

Vascular malformations are birth defects that happen when different stages of angiogenesis shut down. 44 - 64% of all vascular malformations are venous malformations (VMs). Sclerotherapy is the first treatment line for VMs. It acts by getting rid of the vascular endothelial cells in the lesion. One of the most common and well researched sclerosing agents for VMs is polidocanol, which is a popular counterpart for concentrated ethanol.

Study Overview

• Status: Completed
• Conditions: Venous Malformation
• Intervention / Treatment: Procedure: Direct Puncture Repair / Ethanol; Procedure: Direct Puncture Repair / Polidocanol

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt
    • Walied Khereba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 34 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients diagnosed with venous malformation of both genders and age above one year.

Exclusion Criteria:

• Age below one year.
• Patients had any other vascular malformations.
• Indication for contrast material or Alcohol and polidocanol injection.
• Unfit for general anesthesia. 5) Pregnancy. 6) Skin infection, inflammation, and ulcers.
• Pulmonary embolism.
• Acute Ischemia, and acute DVT.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Direct Puncture Repair / Ethanol	Procedure: Direct Puncture Repair / Ethanol; Ethanol is an organic compound that will be injected in the venous malformation as a sclerotherapy by Direct Puncture Repair
Active Comparator: Direct Puncture Repair / Polidocanol	Procedure: Direct Puncture Repair / Polidocanol; Polidocanol is a sclerosing agent that will be injected in the venous malformation by Direct Puncture Repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heaviness questionnaire	Heaviness of the affected part may be unchanged, or decreased or disppeared, or relapsed	6 months post operative
Disfigurement questionnaire	Disfigurementof the affected part may be unchanged, or decreased or disppeared, or relapsed	6 months post operative
size of venous malformation	it assess the size of malformations after injection; which may be unchanged, or decreased or disppeared, or relapsed	6 months post operative
Degree of satisfaction	It may be; Very satisfied, or satisfied, or not satisfied, or Dissatisfied.	6 months post operative

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: October 1, 2022
• First Submitted That Met QC Criteria: October 16, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 16, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Pharmaceutical Solutions; Sclerosing Solutions; Ethanol; Polidocanol
• Other Study ID Numbers: Venous Malformation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No