Dermal Substitution in Pediatric Burns

Study Overview
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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.

Official Title
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Dermal Substitution in Paediatric Burns: A Prospective Case Series

Conditions
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Burns, Burn Scar

Intervention / Treatment
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* Procedure: Glyaderm


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

Ages Eligible for Study
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Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: prospective case series
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar quality (clinician) | Scar quality measured using the Patient and Observer Scar Assessment Scale (POSAS) Observer Scale, which rates the scar from 1 (=like normal skin) to 10 (=worst scar imaginable). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical assessment of the graft take | Take of the split thickness skin graft (STSG) in percentages. The take is defined as STSG that appears vital and is adherent to the wound bed. | 5-7 days after STSG application | 
| Wound epithelialization | Wound epithelialization is the percentage of the graft with a vital skin graft and healed graft interstices. | 5-7 days after STSG application | 
| Wound healing time | >95% epithelialization of the wound area is considered as healed | determined in the first several days to weeks after STSG application | 
| Donor site healing time | >95% epithelialisation of the donor site wound surface area is considered as healed | determined in the first several days to weeks after STSG application | 
| Scar surface area | The scar surface area is calculated using the surgery wound as reference area | day of surgery (day 0) and 3, 6 and 12 months post-surgery | 
| Scar quality (participant) | Scar quality measured using the Patient and Observer Scar Assessment Scale (POSAS) Patient Scale, rating the scar from 1 (=like normal skin) to 10 (=worst scar imaginable). | 3, 6 and 12 months post-surgery | 
| Occurrence of scar contractures | Scar contractures often occur in children with deep dermal and full thickness burn wounds. | Up to 12 months post-surgery | 
| Occurrence of scar hypertrophy | Scar hypertrophy often occurs in children with deep dermal and full thickness burn wounds. | Up to 12 months post-surgery | 
| Range of motion of affected joints | When joints are affected due to the burn wound, the range of motion of the affected joint(s) will be monitored during follow-up. | 3, 6 and 12 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burns, Scar quality, Pediatric