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Dermal Substitution in Pediatric Burns (GlyPeB)

Primary Purpose

Burns, Burn Scar

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Glyaderm
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Burns, Scar quality, Pediatric

Eligibility Criteria

undefined - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • RadboudumcRecruiting

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Wound epithelialization
Wound epithelialization is the percentage of the graft with a vital skin graft and healed graft interstices.
Wound healing time
>95% epithelialization of the wound area is considered as healed
Donor site healing time
>95% epithelialisation of the donor site wound surface area is considered as healed
Scar surface area
The scar surface area is calculated using the surgery wound as reference area
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).
Occurrence of scar contractures
Scar contractures often occur in children with deep dermal and full thickness burn wounds.
Occurrence of scar hypertrophy
Scar hypertrophy often occurs in children with deep dermal and full thickness burn wounds.
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.

Full Information

First Posted
March 15, 2022
Last Updated
October 25, 2022
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05309720
Brief Title
Dermal Substitution in Pediatric Burns
Acronym
GlyPeB
Official Title
Dermal Substitution in Paediatric Burns: A Prospective Case Series
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Burn Scar
Keywords
Burns, Scar quality, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective case series
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Glyaderm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Scar quality (clinician)
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Clinical assessment of the graft take
Description
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.
Time Frame
5-7 days after STSG application
Title
Wound epithelialization
Description
Wound epithelialization is the percentage of the graft with a vital skin graft and healed graft interstices.
Time Frame
5-7 days after STSG application
Title
Wound healing time
Description
>95% epithelialization of the wound area is considered as healed
Time Frame
determined in the first several days to weeks after STSG application
Title
Donor site healing time
Description
>95% epithelialisation of the donor site wound surface area is considered as healed
Time Frame
determined in the first several days to weeks after STSG application
Title
Scar surface area
Description
The scar surface area is calculated using the surgery wound as reference area
Time Frame
day of surgery (day 0) and 3, 6 and 12 months post-surgery
Title
Scar quality (participant)
Description
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).
Time Frame
3, 6 and 12 months post-surgery
Title
Occurrence of scar contractures
Description
Scar contractures often occur in children with deep dermal and full thickness burn wounds.
Time Frame
Up to 12 months post-surgery
Title
Occurrence of scar hypertrophy
Description
Scar hypertrophy often occurs in children with deep dermal and full thickness burn wounds.
Time Frame
Up to 12 months post-surgery
Title
Range of motion of affected joints
Description
When joints are affected due to the burn wound, the range of motion of the affected joint(s) will be monitored during follow-up.
Time Frame
3, 6 and 12 months post-surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elleke Munk, MD
Phone
0031 24 361 1111
Email
elleke.munk@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marielle Vehmeijer-Heeman, MD, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elleke Munk, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Dermal Substitution in Pediatric Burns

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