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

Vascular Diseases Clinical Trial

— DOUBLE-SKIN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04999618
• Other study ID #: CVPMoscow
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2020
• Est. completion date: October 27, 2021

Study information

• Verified date: October 2021
• Source: Center for Vascular Pathology, Moscow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 27, 2021
• Est. primary completion date: August 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

Inclusion Criteria:

• clinically diagnosed Vascular Pathology

Exclusion Criteria:

• age

• severe allergic reaction

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Brain Stem Infarctions
• Congenital Abnormalities
• Hemangioma, Capillary
• Port-Wine Stain
• Sturge-Weber Syndrome
• Vascular Diseases
• Vascular Malformation
• Vascular Malformations

Intervention

Drug:
• Haemoblock
Delivering with transdermal patches

Other:
• Placebo
Delivering with transdermal patches

Locations

Country	Name	City	State
Russian Federation	The Vascular Anomalies Center (VAC) "Hemangioma"	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Center for Vascular Pathology, Moscow

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Preventing likelihood of mental health issues	Validated scales	Early postoperative period and at 3 weeks
Primary	Preventing negative outcomes of postoperative infection	Validated scales	Early postoperative period and at 3 weeks
Secondary	Preventing prolonged functional recovery	Validated scales	Early postoperative period and at 3 weeks