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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group with Haemoblock (A) | Active Comparator |
| |
| Group without Haemoblock (B) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haemoblock | Drug | Delivering with transdermal patches |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Preventing negative outcomes of postoperative infection | Validated scales | Early postoperative period and at 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Preventing prolonged functional recovery | Validated scales | Early postoperative period and at 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Preventing likelihood of mental health issues | Validated scales | Early postoperative period and at 3 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ekaterina M Listovskaya, BSc | The Vascular Anomalies Center (VAC) "Hemangioma", | Principal Investigator |
| Dmitry V Romanov, MD | The Vascular Anomalies Center (VAC) "Hemangioma" | Study Chair |
| Alexander Plotkin, PhD | Moscow Regional Research Institute of Blood | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Vascular Anomalies Center (VAC) "Hemangioma" | Moscow | 109028 | Russia |
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Participants, clinicians and the research team, completing baseline and follow-up assessments were masked to group allocation.
| Placebo |
| Other |
Delivering with transdermal patches |
|
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D054079 | Vascular Malformations |
| C564254 | Capillary Malformation-Arteriovenous Malformation |
| D019339 | Port-Wine Stain |
| D013341 | Sturge-Weber Syndrome |
| D019043 | Vascular Neoplasms |
| C562760 | Capillary Malformations, Congenital, 1 |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012868 | Skin Abnormalities |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006391 | Hemangioma |
| D009383 | Neoplasms, Vascular Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020752 | Neurocutaneous Syndromes |
| D009422 | Nervous System Diseases |
| D000798 | Angiomatosis |
| D012983 | Soft Tissue Neoplasms |
| D009371 | Neoplasms by Site |
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