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

NCT ID: NCT04999618

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-10-27

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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Vascular Diseases Laser treatment Capillary Malformation Port-Wine Stain Vascular Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Participants, clinicians and the research team, completing baseline and follow-up assessments were masked to group allocation.

Study Groups

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Group with Haemoblock (A)

Group Type ACTIVE_COMPARATOR

Haemoblock

Intervention Type DRUG

Delivering with transdermal patches

Group without Haemoblock (B)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Delivering with transdermal patches

Interventions

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Haemoblock

Delivering with transdermal patches

Intervention Type DRUG

Placebo

Delivering with transdermal patches

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* clinically diagnosed Vascular Pathology

Exclusion Criteria

* age
* severe allergic reaction
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Center for Vascular Pathology, Moscow

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ekaterina M Listovskaya, BSc

Role: PRINCIPAL_INVESTIGATOR

The Vascular Anomalies Center (VAC) "Hemangioma",

Dmitry V Romanov, MD

Role: STUDY_CHAIR

The Vascular Anomalies Center (VAC) "Hemangioma"

Alexander Plotkin, PhD

Role: STUDY_CHAIR

Moscow Regional Research Institute of Blood

Locations

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The Vascular Anomalies Center (VAC) "Hemangioma"

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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CVPMoscow

Identifier Type: -

Identifier Source: org_study_id