Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Capillary Malformation-Arteriovenous Malformation | — | UNRESOLVED | — |
| Port-Wine Stain | — | UNRESOLVED | — |
| Sturge-Weber Syndrome | — | UNRESOLVED | — |
| Vascular Diseases | — | UNRESOLVED | — |
| Vascular Malformation | — | UNRESOLVED | — |
| Vascular Tumor | Vascular Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Haemoblock | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group with Haemoblock (A)
- interventionNames
- Drug: Haemoblock
- type
- PLACEBO_COMPARATOR
- label
- Group without Haemoblock (B)
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Preventing negative outcomes of postoperative infection
- timeFrame
- Early postoperative period and at 3 weeks
- description
- Validated scales
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * clinically diagnosed Vascular Pathology Exclusion Criteria: * age * severe allergic reaction
References
Publications (0)
Data not yet available