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

NCT04999618 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-11-04

No results posted yet for this study

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

DRUG

Haemoblock

Delivering with transdermal patches

OTHER

Placebo

Delivering with transdermal patches

Sponsors & Collaborators

  • Center for Vascular Pathology, Moscow

    lead OTHER

Principal Investigators

  • Ekaterina M Listovskaya, BSc · The Vascular Anomalies Center (VAC) "Hemangioma",

  • Dmitry V Romanov, MD · The Vascular Anomalies Center (VAC) "Hemangioma"

  • Alexander Plotkin, PhD · Moscow Regional Research Institute of Blood

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-08-27
Completion
2021-10-27

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04999618 on ClinicalTrials.gov