A New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology (DOUBLE-SKIN)

Center for Vascular Pathology, Moscow

Status and phase: Completed; Phase 4

Conditions: Sturge-Weber Syndrome; Capillary Malformation-Arteriovenous Malformation; Port-Wine Stain; Vascular Diseases; Vascular Tumor; Vascular Malformation

Treatments: Other: Placebo; Drug: Haemoblock

Study type: Interventional

Funder types: Other

Identifiers

NCT04999618

CVPMoscow

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinically diagnosed Vascular Pathology

Exclusion criteria

• age
• severe allergic reaction

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Group with Haemoblock (A)

Active Comparator group

Treatment:

Drug: Haemoblock

Group without Haemoblock (B)

Placebo Comparator group

Treatment:

Other: Placebo