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

Sponsor

Center for Vascular Pathology, Moscow (Other)

Overall Status

Completed

CT.gov ID

NCT04999618

Collaborator

(none)

200

Enrollment

Location

Arms

21.8

Actual Duration (Months)

9.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Diseases Vascular Malformation Capillary Malformation-Arteriovenous Malformation Port-Wine Stain Sturge-Weber Syndrome Vascular Tumor	Drug: Haemoblock Other: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Prevention

Official 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

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

Aug 27, 2021

Actual Study Completion Date :

Oct 27, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Preventing negative outcomes of postoperative infection [Early postoperative period and at 3 weeks]
Validated scales

Secondary Outcome Measures

Preventing prolonged functional recovery [Early postoperative period and at 3 weeks]
Validated scales

Other Outcome Measures

Preventing likelihood of mental health issues [Early postoperative period and at 3 weeks]
Validated scales

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

clinically diagnosed Vascular Pathology

Exclusion Criteria:

age
severe allergic reaction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Vascular Anomalies Center (VAC) "Hemangioma"	Moscow		Russian Federation	109028

Sponsors and Collaborators

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