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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04999618
Recruitment Status : Completed
First Posted : August 11, 2021
Last Update Posted : November 4, 2021
Sponsor:
Information provided by (Responsible Party):
Center for Vascular Pathology, Moscow

Study Description
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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.

Condition or disease Intervention/treatment Phase
Vascular Diseases Vascular Malformation Capillary Malformation-Arteriovenous Malformation Port-Wine Stain Sturge-Weber Syndrome Vascular Tumor Drug: Haemoblock Other: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants, clinicians and the research team, completing baseline and follow-up assessments were masked to group allocation.
Primary Purpose: Prevention
Official 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
Actual Study Start Date : January 1, 2020
Actual Primary Completion Date : August 27, 2021
Actual Study Completion Date : October 27, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group with Haemoblock (A) Drug: Haemoblock
Delivering with transdermal patches
Placebo Comparator: Group without Haemoblock (B) Other: Placebo
Delivering with transdermal patches


Outcome Measures
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Primary Outcome Measures :
  1. Preventing negative outcomes of postoperative infection [ Time Frame: Early postoperative period and at 3 weeks ]
    Validated scales


Secondary Outcome Measures :
  1. Preventing prolonged functional recovery [ Time Frame: Early postoperative period and at 3 weeks ]
    Validated scales


Other Outcome Measures:
  1. Preventing likelihood of mental health issues [ Time Frame: Early postoperative period and at 3 weeks ]
    Validated scales


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinically diagnosed Vascular Pathology

Exclusion Criteria:

  • age
  • severe allergic reaction
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04999618


Locations
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Russian Federation
The Vascular Anomalies Center (VAC) "Hemangioma"
Moscow, Russian Federation, 109028
Sponsors and Collaborators
Center for Vascular Pathology, Moscow
Investigators
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Principal Investigator: Ekaterina M Listovskaya, BSc The Vascular Anomalies Center (VAC) "Hemangioma",
Study Chair: Dmitry V Romanov, MD The Vascular Anomalies Center (VAC) "Hemangioma"
Study Chair: Alexander Plotkin, PhD Moscow Regional Research Institute of Blood
More Information
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Responsible Party: Center for Vascular Pathology, Moscow
ClinicalTrials.gov Identifier: NCT04999618    
Other Study ID Numbers: CVPMoscow
First Posted: August 11, 2021    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Center for Vascular Pathology, Moscow:
Vascular Diseases
Laser treatment
Capillary Malformation
Port-Wine Stain
Vascular Tumor
Additional relevant MeSH terms:
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Hemangioma, Capillary
Sturge-Weber Syndrome
Neoplasms, Vascular Tissue
Vascular Neoplasms
Brain Stem Infarctions
Vascular Diseases
Arteriovenous Malformations
Vascular Malformations
Congenital Abnormalities
Port-Wine Stain
Cardiovascular Diseases
Cardiovascular Abnormalities
Skin Abnormalities
Skin Diseases
Hemangioma
 Neoplasms by Histologic Type
Neoplasms
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Infarction
Ischemia
Pathologic Processes
Necrosis
Angiomatosis
Neurocutaneous Syndromes