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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04999618
Acronym
DOUBLE-SKIN
Enrollment
200
Registered
2021-08-11
Start date
2020-01-01
Completion date
2021-10-27
Last updated
2021-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Capillary Malformation-Arteriovenous Malformation, Port-Wine Stain, Sturge-Weber Syndrome, Vascular Diseases, Vascular Malformation, Vascular Tumor

Keywords

Vascular Diseases, Laser treatment, Capillary Malformation, Port-Wine Stain, Vascular Tumor

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.

Interventions

DRUGHaemoblock

Delivering with transdermal patches

OTHERPlacebo

Delivering with transdermal patches

Sponsors

Center for Vascular Pathology, Moscow
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Participants, clinicians and the research team, completing baseline and follow-up assessments were masked to group allocation.

Eligibility

Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No

Inclusion criteria

* clinically diagnosed Vascular Pathology

Exclusion criteria

* age * severe allergic reaction

Design outcomes

Primary

MeasureTime frameDescription
Preventing negative outcomes of postoperative infectionEarly postoperative period and at 3 weeksValidated scales

Secondary

MeasureTime frameDescription
Preventing prolonged functional recoveryEarly postoperative period and at 3 weeksValidated scales

Other

MeasureTime frameDescription
Preventing likelihood of mental health issuesEarly postoperative period and at 3 weeksValidated scales

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026