Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT05309720
Status:
UNKNOWN
Last Update Posted:
2024-04-12
First Post:
2022-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dermal Substitution in Pediatric Burns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'prospective case series'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-10', 'studyFirstSubmitDate': '2022-03-15', 'studyFirstSubmitQcDate': '2022-03-24', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scar quality (clinician)', 'timeFrame': '12 months', 'description': 'Scar quality measured using the Patient and Observer Scar Assessment Scale (POSAS) Observer Scale, which rates the scar from 1 (=like normal skin) to 10 (=worst scar imaginable).'}], 'secondaryOutcomes': [{'measure': 'Clinical assessment of the graft take', 'timeFrame': '5-7 days after STSG application', 'description': 'Take of the split thickness skin graft (STSG) in percentages. The take is defined as STSG that appears vital and is adherent to the wound bed.'}, {'measure': 'Wound epithelialization', 'timeFrame': '5-7 days after STSG application', 'description': 'Wound epithelialization is the percentage of the graft with a vital skin graft and healed graft interstices.'}, {'measure': 'Wound healing time', 'timeFrame': 'determined in the first several days to weeks after STSG application', 'description': '\\>95% epithelialization of the wound area is considered as healed'}, {'measure': 'Donor site healing time', 'timeFrame': 'determined in the first several days to weeks after STSG application', 'description': '\\>95% epithelialisation of the donor site wound surface area is considered as healed'}, {'measure': 'Scar surface area', 'timeFrame': 'day of surgery (day 0) and 3, 6 and 12 months post-surgery', 'description': 'The scar surface area is calculated using the surgery wound as reference area'}, {'measure': 'Scar quality (participant)', 'timeFrame': '3, 6 and 12 months post-surgery', 'description': 'Scar quality measured using the Patient and Observer Scar Assessment Scale (POSAS) Patient Scale, rating the scar from 1 (=like normal skin) to 10 (=worst scar imaginable).'}, {'measure': 'Occurrence of scar contractures', 'timeFrame': 'Up to 12 months post-surgery', 'description': 'Scar contractures often occur in children with deep dermal and full thickness burn wounds.'}, {'measure': 'Occurrence of scar hypertrophy', 'timeFrame': 'Up to 12 months post-surgery', 'description': 'Scar hypertrophy often occurs in children with deep dermal and full thickness burn wounds.'}, {'measure': 'Range of motion of affected joints', 'timeFrame': '3, 6 and 12 months post-surgery', 'description': 'When joints are affected due to the burn wound, the range of motion of the affected joint(s) will be monitored during follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Burns', 'Scar quality', 'Pediatric'], 'conditions': ['Burns', 'Burn Scar']}, 'descriptionModule': {'briefSummary': 'The standard treatment of deep dermal to full thickness burns is surgical removal of the burn followed by skin transplantation. Dermal substitutes are increasingly used in the treatment of deep burns to replace lost dermis. Preservation of the collagen and elastin in the acellular human dermal substitute Glyaderm provides a more elastic scar. It is unknown what the effect of Glyaderm on scar quality is in a solely paediatric population.\n\nThe objective of this case series is to investigate scar maturation and scar quality when applying Glyaderm in deep dermal to full thickness burns in a pediatric population aged ≤15 years old.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≤15 years old\n2. Burn wounds requiring skin grafting\n3. Written informed consent provided by\n\n 1. The participant's parent(s)/guardian (\\<12 years of age)\n 2. The participant's parent(s)/guardian and the participant itself (12-15 years old)\n\nExclusion Criteria:\n\n1. Burn wound of ≤30 cm2\n2. Infected burn wounds: clinical symptoms in combination with positive wound swabs\n3. Patients/parents with insufficient knowledge of the Dutch or English language, since they would not be able to complete the POSAS questionnaire."}, 'identificationModule': {'nctId': 'NCT05309720', 'acronym': 'GlyPeB', 'briefTitle': 'Dermal Substitution in Pediatric Burns', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Dermal Substitution in Paediatric Burns: A Prospective Case Series', 'orgStudyIdInfo': {'id': '2022-13625'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glyaderm', 'interventionNames': ['Procedure: Glyaderm']}], 'interventions': [{'name': 'Glyaderm', 'type': 'PROCEDURE', 'description': 'All included patients will undergo full thickness removal of the burned skin or adequate debridement of all necrotic tissue. Next, the dermal substitute Glyaderm followed by a split thickness skin graft will be transplanted on the wound.', 'armGroupLabels': ['Glyaderm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nijmegen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Elleke Munk, MD', 'role': 'CONTACT'}], 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'centralContacts': [{'name': 'Milly van de Warenburg, MD', 'role': 'CONTACT', 'email': 'milly.vandewarenburg@radboudumc.nl', 'phone': '0031 24 361 1111'}], 'overallOfficials': [{'name': 'Marielle Vehmeijer-Heeman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}