The aim of this study is to investigate 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
Outcome measures
Primary outcome
The main study parameter is the scar quality measured with the POSAS observer
scale at 3, 6 and 12 months post-operatively.
Secondary outcome
- 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*
- 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.
Background summary
Burn scars can have an enormous impact on a child*s life, affecting its
physical, psychological and social wellbeing (1, 2). Children are especially at
risk to develop hypertrophic scars after a burn injury, due to excessive
proliferation of scar tissue (3). Poor scar quality in hypertrophic scars is
characterized by red, raised scars that cause pain and pruritus (4, 5). Risk
factors associated with hypertrophic scar formation are younger age, dark skin
type, longer time to heal and mechanical tension amongst others (6). Treatment
options to improve scar quality consist of pressure garments, silicone gel
sheets, corticosteroids, laser therapy and reconstructive surgery (4). Due to
their growth, children often require multiple reconstructions and contracture
releases after severe burn scarring (7).
Depending on a burn*s depth, burns are either treated conservatively with
dressings or require excision of the eschar to improve healing. Scar prevention
begins in the acute care, and thus optimal treatment is paramount to improve
long term outcomes (4). The gold standard for the treatment of deep dermal
(which affects epidermis and most of the dermis) to full thickness burns (at
least epidermis and all of the dermis) is excision of the eschar and autologous
epidermal skin transplantation using split thickness skin grafts (STSGs). Only
the epidermis is replaced with this technique. In order to replace the dermis,
dermal substitutes are used in acute burn care since the 1980s (8). These
dermal substitutes lead to an improved scar quality (9).
In the human acellular dermal substitute Glyaderm the structure of the
extracellular matrix containing collagen and elastin is preserved (10).
Collagen provides structure and tensile strength to the skin, whereas elastin
provides elasticity. Studies show improved scar elasticity over time after
application of Glyaderm in combination with split thickness skin graft versus
split thickness skin grafts alone (11, 12). The clinical trial was conducted in
a heterogenous population, consisting of both burn and trauma patients and
covering a wide age range from 1 to 74 years old (11).
Studies investigating the efficacy of dermal substitution in burns are
primarily conducted in adult populations (9, 11-15). There is thus a lack of
reporting on the effect of dermal substitution in exclusively paediatric burn
populations.
Study objective
The aim of this study is to investigate the scar quality in a paediatric burn
population treated with Glyaderm up to 12 months after surgery.
Study design
Prospective case series.
Intervention
Glyaderm applied on the burn wound, followed by a split thickness skin graft.
Study burden and risks
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 at 3, 6
and 12 months. Based on previous studies an improved scar quality is to be
expected when using Glyaderm compared to the gold standard of only split
thickness skin graft.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
1. Age <=15 years old
2. Burn wounds requiring skin grafting
3. Written informed consent provided by
a. The participant*s parent(s)/guardian (<12 years of age)
b. 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.
Design
Recruitment
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 |
| CCMO | NL81000.091.22 |