Dermal Substitution in Pediatric Burns

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Mar 24, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how a special skin substitute, called Glyaderm, can help improve the healing of serious burns in children. When kids suffer deep burns, doctors usually remove the damaged skin and then cover the area with a skin graft. Glyaderm is designed to replace some of the skin layers that are lost, potentially leading to better scars that feel softer and more elastic. The study aims to see how well Glyaderm works specifically for kids aged 15 and younger who have deep burns that need skin grafting.

To be eligible for this trial, children must be 15 years old or younger and have burn wounds that are large enough to require a skin graft. Parents or guardians will need to give their permission, and older children (ages 12-15) will also need to agree to participate. It's important to note that children with very small burns, infected wounds, or language barriers that prevent them from understanding the study won't be included. Participants will have regular check-ups to monitor how their scars heal, and the information gathered will help researchers understand the benefits of using Glyaderm in treating burns in children.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≤15 years old
• • 2. Burn wounds requiring skin grafting
• • 3. Written informed consent provided by
• • 1. The participant's parent(s)/guardian (\<12 years of age)
• • 2. The participant's parent(s)/guardian and the participant itself (12-15 years old)
• Exclusion Criteria:
• • 1. Burn wound of ≤30 cm2
• • 2. Infected burn wounds: clinical symptoms in combination with positive wound swabs
• • 3. Patients/parents with insufficient knowledge of the Dutch or English language, since they would not be able to complete the POSAS questionnaire.