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OpenTrials
Completed

NCT Number: NCT04999618

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

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.

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Key information

Conditions

Vascular Diseases Angiomatosis Capillary Malformation-Arteriovenous Malformation Capillary Malformations, Congenital, 1 Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hemangioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Vascular Tissue Nervous System Diseases Neurocutaneous Syndromes Port-Wine Stain Skin Abnormalities Skin Diseases Skin and Connective Tissue Diseases Soft Tissue Neoplasms Sturge-Weber Syndrome Vascular Malformation Vascular Malformations Vascular Neoplasms Vascular Tumor

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Vascular Anomalies Center (VAC) "Hemangioma"

Moscow, 109028, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinically diagnosed Vascular Pathology

Exclusion criteria

  • age
  • severe allergic reaction

Treatment and study plan

Haemoblock

Drug

Delivering with transdermal patches

Placebo

Other

Delivering with transdermal patches

Primary outcomes

  1. Preventing negative outcomes of postoperative infection

    Time frame: Early postoperative period and at 3 weeks

    Validated scales

Secondary outcomes

  1. Preventing prolonged functional recovery

    Time frame: Early postoperative period and at 3 weeks

    Validated scales

Other outcomes

  1. Preventing likelihood of mental health issues

    Time frame: Early postoperative period and at 3 weeks

    Validated scales

Sponsors and collaborators

Lead sponsor

Center for Vascular Pathology, Moscow

Other

Registry information

Official study title

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

Acronym: DOUBLE-SKIN

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 11, 2021
Registry last updated
Nov 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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