Using Glyaderm for treating burns in children
Dermal Substitution in Paediatric Burns: A Prospective Case Series
This study tests if using Glyaderm can improve scar quality in children with serious burns who need skin grafts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | N/A to 15 Years |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen) |
| Trial ID | NCT05309720 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Glyaderm, an acellular human dermal substitute, on scar quality in pediatric patients with deep dermal to full thickness burns. The research focuses on children aged 15 years and younger who require skin grafting due to their burn injuries. By evaluating scar maturation and quality, the study aims to determine the benefits of using Glyaderm compared to standard treatments. Participants will be monitored for their scar outcomes following the application of this dermal substitute.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 15 years or younger with burn wounds that necessitate skin grafting.
Not a fit: Patients with small burn wounds (≤30 cm2) or those with infected burn wounds may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved scar quality and healing outcomes for children with severe burn injuries.
How similar studies have performed: While the use of dermal substitutes in burn treatment is established, the specific application of Glyaderm in a solely pediatric population is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nijmegen
- Radboudumc — Nijmegen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Marielle Vehmeijer-Heeman, MD, PhD — Radboud University Medical Center
- Study coordinator: Milly van de Warenburg, MD
- Email: milly.vandewarenburg@radboudumc.nl
- Phone: 0031 24 361 1111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.