Dermal Substitution in Pediatric Burns

Burns Clinical Trial

— GlyPeB  

Official title:

Dermal Substitution in Paediatric Burns: A Prospective Case Series

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05309720
• Other study ID #: 2022-13625
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: November 1, 2025

Study information

• Verified date: November 2023
• Source: Radboud University Medical Center
• Contact: Milly van de Warenburg, MD
• Phone: 0031 24 361 1111
• Email: milly.vandewarenburg[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burn Scar
• Burns

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Wound healing time	>95% epithelialization of the wound area is considered as healed	determined in the first several days to weeks after STSG application
Secondary	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
Secondary	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
Secondary	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
Secondary	Occurrence of scar contractures	Scar contractures often occur in children with deep dermal and full thickness burn wounds.	Up to 12 months post-surgery
Secondary	Occurrence of scar hypertrophy	Scar hypertrophy often occurs in children with deep dermal and full thickness burn wounds.	Up to 12 months post-surgery
Secondary	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