Back to resultsA New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology (DOUBLE-SKIN)
Primary Purpose
Vascular Diseases, Vascular Malformation, Capillary Malformation-Arteriovenous Malformation
Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Haemoblock
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Vascular Diseases focused on measuring Vascular Diseases, Laser treatment, Capillary Malformation, Port-Wine Stain, Vascular Tumor
Eligibility Criteria
Inclusion Criteria:
- clinically diagnosed Vascular Pathology
Exclusion Criteria:
- age
- severe allergic reaction
Sites / Locations
- The Vascular Anomalies Center (VAC) "Hemangioma"
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group with Haemoblock (A)
Group without Haemoblock (B)
Arm Description
Outcomes
Primary Outcome Measures
Preventing negative outcomes of postoperative infection
Validated scales
Secondary Outcome Measures
Preventing prolonged functional recovery
Validated scales
Full Information
NCT ID
NCT04999618
First Posted
July 17, 2021
Last Updated
October 27, 2021
Sponsor
Center for Vascular Pathology, Moscow
1. Study Identification
Unique Protocol Identification Number
NCT04999618
Brief Title
A New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology
Acronym
DOUBLE-SKIN
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
August 27, 2021 (Actual)
Study Completion Date
October 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Vascular Pathology, Moscow
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases, Vascular Malformation, Capillary Malformation-Arteriovenous Malformation, Port-Wine Stain, Sturge-Weber Syndrome, Vascular Tumor
Keywords
Vascular Diseases, Laser treatment, Capillary Malformation, Port-Wine Stain, Vascular Tumor
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participants, clinicians and the research team, completing baseline and follow-up assessments were masked to group allocation.
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group with Haemoblock (A)
Arm Type
Active Comparator
Arm Title
Group without Haemoblock (B)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Haemoblock
Intervention Description
Delivering with transdermal patches
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Delivering with transdermal patches
Primary Outcome Measure Information:
Title
Preventing negative outcomes of postoperative infection
Description
Validated scales
Time Frame
Early postoperative period and at 3 weeks
Secondary Outcome Measure Information:
Title
Preventing prolonged functional recovery
Description
Validated scales
Time Frame
Early postoperative period and at 3 weeks
Other Pre-specified Outcome Measures:
Title
Preventing likelihood of mental health issues
Description
Validated scales
Time Frame
Early postoperative period and at 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinically diagnosed Vascular Pathology
Exclusion Criteria:
age
severe allergic reaction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ekaterina M Listovskaya, BSc
Organizational Affiliation
The Vascular Anomalies Center (VAC) "Hemangioma",
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dmitry V Romanov, MD
Organizational Affiliation
The Vascular Anomalies Center (VAC) "Hemangioma"
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alexander Plotkin, PhD
Organizational Affiliation
Moscow Regional Research Institute of Blood
Official's Role
Study Chair
Facility Information:
Facility Name
The Vascular Anomalies Center (VAC) "Hemangioma"
City
Moscow
ZIP/Postal Code
109028
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
A New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology
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