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

Phase 4

Completed

• Conditions: Vascular Diseases; Vascular Tumor; Vascular Malformation; Port-Wine Stain; Capillary Malformation-Arteriovenous Malformation; Sturge-Weber Syndrome
• Interventions: Drug: Haemoblock; Other: Placebo

• Registration Number: NCT04999618
• Lead Sponsor: Center for Vascular Pathology, Moscow

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-07-17
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-11
• Primary Completion: 2021-08-27
• Status Verified: 2021-10
• Study Completion: 2021-10-27
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• clinically diagnosed Vascular Pathology

Exclusion Criteria

• age
• severe allergic reaction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group with Haemoblock (A)	Haemoblock	-
Group without Haemoblock (B)	Placebo	-

Primary Outcome Measures

Name	Time	Method
Preventing negative outcomes of postoperative infection	Early postoperative period and at 3 weeks	Validated scales

Secondary Outcome Measures

Name	Time	Method
Preventing prolonged functional recovery	Early postoperative period and at 3 weeks	Validated scales

Trial Locations

Locations (1)

The Vascular Anomalies Center (VAC) "Hemangioma"; 🇷🇺 Moscow, Russian Federation