BurnsGlyPeBNCT05309720
Dermal Substitution in Pediatric Burns
A study testing Glyaderm in people with Burns and Burn Scar, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages Up to 15 years
- What is being tested?
- Glyaderm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2022to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen
Elleke Munk, MD
About this study
Official title: 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.
- Being tested
- Glyaderm
- Keywords
- Burns, Scar quality, Pediatric
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlyadermProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Glyaderm | Experimental | Not described Receives: Procedure: Glyaderm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 5-7 days after STSG application
Wound healing time
>95% epithelialization of the wound area is considered as healed
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: Up to 12 months post-surgery
Occurrence of scar hypertrophy
Scar hypertrophy often occurs in children with deep dermal and full thickness burn wounds.
Measured: 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.
Measured: 3, 6 and 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Sep 2022
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective case series
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marielle Vehmeijer-Heeman, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309720
- Sponsor's protocol ID
- 2022-13625
- Acronym
- GlyPeB
- Status last verified
- Nov 2023
- First submitted
- 15 Mar 2022
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermal Substitution in Paediatric Burns: A Prospective Case Series
- ClinicalTrials.gov ID
- NCT05309720
- Acronym / sponsor ID
- GlyPeB / 2022-13625
- Keywords
- Burns, Scar quality, Pediatric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective case series
| Arm | Type | Receives |
|---|---|---|
| Glyaderm | Experimental | Procedure: Glyaderm |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age ≤15 years old
- Burn wounds requiring skin grafting
- Written informed consent provided by
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlyadermAll 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. | Procedure or surgery | Glyaderm |
Primary outcome
Scar quality (clinician)
Time frame: 12 months
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).
9 secondary outcomes
Clinical assessment of the graft take
Time frame: 5-7 days after STSG application
Wound epithelialization
Time frame: 5-7 days after STSG application
Wound healing time
Time frame: determined in the first several days to weeks after STSG application
Donor site healing time
Time frame: determined in the first several days to weeks after STSG application
Scar surface area
Time frame: day of surgery (day 0) and 3, 6 and 12 months post-surgery
Scar quality (participant)
Time frame: 3, 6 and 12 months post-surgery
Occurrence of scar contractures
Time frame: Up to 12 months post-surgery
Occurrence of scar hypertrophy
Time frame: Up to 12 months post-surgery
Range of motion of affected joints
Time frame: 3, 6 and 12 months post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marielle Vehmeijer-Heeman, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glyaderm in people with Burns and Burn Scar, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Milly van de Warenburg, MD (0031 24 361 1111, milly.vandewarenburg@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar quality (clinician) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.