NCT04999618

A New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology

DOUBLE-SKIN: a New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology: a Randomised, Double-blind, Placebo-controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Center for Vascular Pathology, Moscow · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

Laser treatment (LT) is the first-line treatment for Vascular Pathology. However even when LT is based on the selective photothermolysis it causes the first-degree burns. While being typically benign by affecting only the epidermis, or outer layer of skin, the burn site is remaining red, dry, and very painful. As Haemoblock contains nanoparticles of silver and is known for both bactericidal and bacteriostatic effects, it likely decreases the potential for infection postoperatively. Furthermore, after fibrin replaces the superficial structure "Hemoblock-albumin", the polyacrylate matrix is plasmolyzed which initiates the cascade of signals required for the tissue regeneration processes. Objective of the study was to examine the effect of the Regenerative Solution "Hemoblock" in lowering postoperative complications in children diagnosed with Vascular Pathology undergoing a laser surgery if delivered with transdermal patches.

Conditions

• Vascular Diseases
• Vascular Malformation
• Capillary Malformation-Arteriovenous Malformation
• Port-Wine Stain
• Sturge-Weber Syndrome
• Vascular Tumor

Interventions

Type	Name	Description
DRUG	Haemoblock	Delivering with transdermal patches
OTHER	Placebo	Delivering with transdermal patches

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-08-27
• Completion: 2021-10-27
• First posted: 2021-08-11
• Last updated: 2021-11-04

Locations

1 site across 1 country: Russia