Dermal Substitution in Pediatric Burns (GlyPeB)

Dermal Substitution in Paediatric Burns: A Prospective Case Series

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.

Study Overview

• Status: Recruiting
• Conditions: Burn Scar; Burns
• Intervention / Treatment: Procedure: Glyaderm

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Milly van de Warenburg, MD; Phone Number: 0031 24 361 1111; Email: milly.vandewarenburg@radboudumc.nl

Study Locations

• Netherlands
  • Nijmegen, Netherlands
    • Recruiting
    • Radboudumc
    • Contact: Elleke Munk, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glyaderm	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?

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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: Marielle Vehmeijer-Heeman, MD, PhD, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Pediatric; Burns; Scar quality
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 2022-13625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No