Dermal Substitution in Pediatric Burns

Not Applicable

Recruiting

• Conditions: Burns; Burn Scar
• Interventions: Procedure: Glyaderm

• Registration Number: NCT05309720
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-04-04
• Study Start: 2022-09-01
• Status Verified: 2023-11
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glyaderm	Glyaderm	-

Primary Outcome Measures

Name	Time	Method
Scar quality (clinician)	12 months	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).

Secondary Outcome Measures

Name	Time	Method
Clinical assessment of the graft take	5-7 days after STSG application	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.
Wound healing time	determined in the first several days to weeks after STSG application	\>95% epithelialization of the wound area is considered as healed
Wound epithelialization	5-7 days after STSG application	Wound epithelialization is the percentage of the graft with a vital skin graft and healed graft interstices.
Occurrence of scar hypertrophy	Up to 12 months post-surgery	Scar hypertrophy often occurs in children with deep dermal and full thickness burn wounds.
Range of motion of affected joints	3, 6 and 12 months post-surgery	When joints are affected due to the burn wound, the range of motion of the affected joint(s) will be monitored during follow-up.
Scar surface area	day of surgery (day 0) and 3, 6 and 12 months post-surgery	The scar surface area is calculated using the surgery wound as reference area
Donor site healing time	determined in the first several days to weeks after STSG application	\>95% epithelialisation of the donor site wound surface area is considered as healed
Scar quality (participant)	3, 6 and 12 months post-surgery	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).
Occurrence of scar contractures	Up to 12 months post-surgery	Scar contractures often occur in children with deep dermal and full thickness burn wounds.

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Netherlands