Treatment of Venous Malformation

Al-Azhar University

Status: Completed

Conditions: Venous Malformation

Treatments: Procedure: Direct Puncture Repair / Ethanol; Procedure: Direct Puncture Repair / Polidocanol

Study type: Interventional

Funder types: Other

Identifiers

NCT05586919

Venous Malformation

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 months to 36 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Direct Puncture Repair / Ethanol

Active Comparator group

Treatment:

Procedure: Direct Puncture Repair / Ethanol

Direct Puncture Repair / Polidocanol

Active Comparator group

Treatment:

Procedure: Direct Puncture Repair / Polidocanol