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

NCT04999618 | Completed Phase 4

• 1 other identifier: CVPMoscow
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Preventing negative outcomes of postoperative infection

  Validated scales

  Early postoperative period and at 3 weeks

Secondary Outcomes (1)

• Preventing prolonged functional recovery

  Early postoperative period and at 3 weeks

Other Outcomes (1)

• Preventing likelihood of mental health issues

  Early postoperative period and at 3 weeks

Study Arms (2)

Group with Haemoblock (A)

ACTIVE COMPARATOR

Drug: Haemoblock

Group without Haemoblock (B)

PLACEBO COMPARATOR

Other: Placebo

Interventions

Haemoblock DRUG

Delivering with transdermal patches

Group with Haemoblock (A)

Placebo OTHER

Delivering with transdermal patches

Group without Haemoblock (B)

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• clinically diagnosed Vascular Pathology

You may not qualify if:

• age
• severe allergic reaction

Sponsors & Collaborators

• Center for Vascular Pathology, Moscow: lead

Study Sites (1)

The Vascular Anomalies Center (VAC) "Hemangioma"

Moscow, 109028, Russia

Location

MeSH Terms

Conditions

Vascular Diseases; Vascular Malformations; Capillary Malformation-Arteriovenous Malformation; Port-Wine Stain; Sturge-Weber Syndrome; Vascular Neoplasms; Capillary Malformations, Congenital, 1

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms; Neurocutaneous Syndromes; Nervous System Diseases; Angiomatosis; Soft Tissue Neoplasms; Neoplasms by Site

Study Officials

• Ekaterina M Listovskaya, BSc

  The Vascular Anomalies Center (VAC) "Hemangioma",

  PRINCIPAL INVESTIGATOR

• Dmitry V Romanov, MD

  The Vascular Anomalies Center (VAC) "Hemangioma"

  STUDY CHAIR

• Alexander Plotkin, PhD

  Moscow Regional Research Institute of Blood

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, clinicians and the research team, completing baseline and follow-up assessments were masked to group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2021
• First Posted: August 11, 2021
• Study Start: January 1, 2020
• Primary Completion: August 27, 2021
• Study Completion: October 27, 2021
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

RU (1)