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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04999618
Other study ID # CVPMoscow
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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