Vascular Diseases Clinical Trial
— DOUBLE-SKINOfficial 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
Verified date | October 2021 |
Source | Center for Vascular Pathology, Moscow |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | The Vascular Anomalies Center (VAC) "Hemangioma" | Moscow |
Lead Sponsor | Collaborator |
---|---|
Center for Vascular Pathology, Moscow |
Russian Federation,
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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