Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT04999618
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
2021-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'C564254', 'term': 'Capillary Malformation-Arteriovenous Malformation'}, {'id': 'D019339', 'term': 'Port-Wine Stain'}, {'id': 'D013341', 'term': 'Sturge-Weber Syndrome'}, {'id': 'D019043', 'term': 'Vascular Neoplasms'}, {'id': 'C562760', 'term': 'Capillary Malformations, Congenital, 1'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006391', 'term': 'Hemangioma'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020752', 'term': 'Neurocutaneous Syndromes'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000798', 'term': 'Angiomatosis'}, {'id': 'D012983', 'term': 'Soft Tissue Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants, clinicians and the research team, completing baseline and follow-up assessments were masked to group allocation.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-27', 'studyFirstSubmitDate': '2021-07-17', 'studyFirstSubmitQcDate': '2021-08-02', 'lastUpdatePostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Preventing likelihood of mental health issues', 'timeFrame': 'Early postoperative period and at 3 weeks', 'description': 'Validated scales'}], 'primaryOutcomes': [{'measure': 'Preventing negative outcomes of postoperative infection', 'timeFrame': 'Early postoperative period and at 3 weeks', 'description': 'Validated scales'}], 'secondaryOutcomes': [{'measure': 'Preventing prolonged functional recovery', 'timeFrame': 'Early postoperative period and at 3 weeks', 'description': 'Validated scales'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vascular Diseases', 'Laser treatment', 'Capillary Malformation', 'Port-Wine Stain', 'Vascular Tumor'], 'conditions': ['Vascular Diseases', 'Vascular Malformation', 'Capillary Malformation-Arteriovenous Malformation', 'Port-Wine Stain', 'Sturge-Weber Syndrome', 'Vascular Tumor']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinically diagnosed Vascular Pathology\n\nExclusion Criteria:\n\n* age\n* severe allergic reaction'}, 'identificationModule': {'nctId': 'NCT04999618', 'acronym': 'DOUBLE-SKIN', 'briefTitle': 'A New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology', 'organization': {'class': 'OTHER', 'fullName': 'Center for Vascular Pathology, Moscow'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CVPMoscow'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group with Haemoblock (A)', 'interventionNames': ['Drug: Haemoblock']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group without Haemoblock (B)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Haemoblock', 'type': 'DRUG', 'description': 'Delivering with transdermal patches', 'armGroupLabels': ['Group with Haemoblock (A)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Delivering with transdermal patches', 'armGroupLabels': ['Group without Haemoblock (B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '109028', 'city': 'Moscow', 'country': 'Russia', 'facility': 'The Vascular Anomalies Center (VAC) "Hemangioma"', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Ekaterina M Listovskaya, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Vascular Anomalies Center (VAC) "Hemangioma",'}, {'name': 'Dmitry V Romanov, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Vascular Anomalies Center (VAC) "Hemangioma"'}, {'name': 'Alexander Plotkin, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Moscow Regional Research Institute of Blood'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Vascular Pathology, Moscow', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}