Dermal Substitution in Pediatric Burns

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2025-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Burns Burn Scar

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective case series

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glyaderm

Group Type EXPERIMENTAL

Glyaderm

Intervention Type PROCEDURE

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.

Interventions

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Glyaderm

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No