A New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology (DOUBLE-SKIN)

October 27, 2021 updated by: Center for Vascular Pathology, Moscow

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 109028
        • The Vascular Anomalies Center (VAC) "Hemangioma"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinically diagnosed Vascular Pathology

Exclusion Criteria:

  • age
  • severe allergic reaction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group with Haemoblock (A)
Drug: Haemoblock
Delivering with transdermal patches
Placebo Comparator: Group without Haemoblock (B)
Other: Placebo
Delivering with transdermal patches

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preventing negative outcomes of postoperative infection
Time Frame: Early postoperative period and at 3 weeks
Validated scales
Early postoperative period and at 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preventing prolonged functional recovery
Time Frame: Early postoperative period and at 3 weeks
Validated scales
Early postoperative period and at 3 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preventing likelihood of mental health issues
Time Frame: Early postoperative period and at 3 weeks
Validated scales
Early postoperative period and at 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Vascular Pathology, Moscow

Investigators

  • Principal Investigator: Ekaterina M Listovskaya, BSc, The Vascular Anomalies Center (VAC) "Hemangioma",
  • Study Chair: Dmitry V Romanov, MD, The Vascular Anomalies Center (VAC) "Hemangioma"
  • Study Chair: Alexander Plotkin, PhD, Moscow Regional Research Institute of Blood

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

August 27, 2021

Study Completion (Actual)

October 27, 2021

Study Registration Dates

First Submitted

July 17, 2021

First Submitted That Met QC Criteria

August 2, 2021

First Posted (Actual)

August 11, 2021

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVPMoscow

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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