Viewing Study NCT05309720


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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: Radboud University Medical Center
Organization:

Study Overview

Official Title: Dermal Substitution in Paediatric Burns: A Prospective Case Series
Status: UNKNOWN
Status Verified Date: 2023-11
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: GlyPeB
Brief Summary: 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.

The 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.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: