Dermal Substitution in Pediatric Burns

NCT05309720 | Unknown

• 1 other identifier: 2022-13625
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Burn Scar

Keywords

Burns; Scar quality; Pediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Clinical assessment of the graft take

  5-7 days after STSG application

• Wound epithelialization

  5-7 days after STSG application

• Wound healing time

  determined in the first several days to weeks after STSG application

• Donor site healing time

  determined in the first several days to weeks after STSG application

• Scar surface area

  day of surgery (day 0) and 3, 6 and 12 months post-surgery

Study Arms (1)

Glyaderm

EXPERIMENTAL

Procedure: Glyaderm

Interventions

Glyaderm 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.

Glyaderm

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Netherlands

RECRUITING

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Marielle Vehmeijer-Heeman, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Milly van de Warenburg, MD

CONTACT

0031 24 361 1111; milly.vandewarenburg@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective case series

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 4, 2022
• Study Start: September 1, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 12, 2024

Record last verified: 2023-11

Locations

NL (1)