The aim of this study is to describe the scar quality in a paediatric burn population treated with Glyaderm up to 12 months after surgery.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
- Surigical procedure
N.a.
Outcome measures
Primary outcome
<p>Main study parameters/endpoints: The main study parameter is the scar quality measured with the Patient and Observer Scar Assessment Scale (POSAS) observer scale at 3, 6 and 12 months post-operatively. </p>
Secondary outcome
<p>To describe: - Graft take and wound epithelialization at 5-7 days postoperatively - Time to complete wound healing (>95% epithelialization) in days - Time to complete donor site healing in days - Wound/scar surface area at day of surgery and 3, 6 and 12 months post-operatively* - Scar quality using the POSAS patient scale, filled out by the parent at 3, 6 and 12 months post-operatively* - Quality of life using the TAPQOL (6 months to 24 months) or PedsQL (2-15 years) at 3, 6 and 12 months post-operatively. - Rate of scar hypertrophy during follow-up* - Rate of scar contractures during follow-up* - Range of motion (for affected joints) at 3, 6 and 12 months post-operatively* *if parents/patients are willing to extend their participation to 24, 36, 48 and 60 months, these variables will continue to be assessed.</p>
Background summary
Rationale: The gold standard for treatment of deep dermal to full thickness burns is surgical excision of the eschar followed by skin transplantation with split thickness skin grafts to replace lost epidermis. Dermal substitutes are increasingly used in the treatment of deep dermal to full thickness burns to replace lost dermis. The acellular dermal substitute Glyaderm is of human origin. Its application has not been described in a solely paediatric population before. Objective: To describe scar maturation and quality when applying Glyaderm in deep dermal to full thickness burns in a pediatric population.
Study objective
The aim of this study is to describe the scar quality in a paediatric burn population treated with Glyaderm up to 12 months after surgery.
Study design
Study design: Prospective case series. Study population: Children and adolescents aged ≤15 years old.
Intervention
Intervention: Application of Glyaderm in combination with an autologous split thickness skin graft on debrided deep dermal or full thickness burn wounds.
Study burden and risks
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Follow-up appointments for the study are similar to those in standard of care. Parents are asked to fill out the POSAS for the scars of their children and a quality of life scale for their children at 3, 6 and 12 months. Children aged 5 years and older are also asked to fill out a questionnaire on their quality of life.
M.S. van de Warenburg
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
Netherlands
(024) 361 95 94
milly.vandewarenburg@radboudumc.nl
M.S. van de Warenburg
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
Netherlands
(024) 361 95 94
milly.vandewarenburg@radboudumc.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
Full-thickness burn
Pediatric (< 16 years)
Informed consent by parents (<12 years) or parents and patient (12-15 years old)
Exclusion criteria
No informed consent
Burn wound < 30 cm2
Clinically infected wounds
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05309720 |
| Research portal | NL-009758 |