Dermal Substitution in Pediatric Burns (GlyPeB)

Radboud University Medical Center

Status: Enrolling

Conditions: Burns; Burn Scar

Treatments: Procedure: Glyaderm

Study type: Interventional

Funder types: Other

Identifiers

NCT05309720

2022-13625

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: Under 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Glyaderm

Experimental group

Treatment:

Procedure: Glyaderm