Permeaderm Versus Homograft for Full-thickness Burns

Study Overview
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Brief Summary
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Frozen Human Cadaver Allograft (FHCA) is, nowadays, the gold standard for temporary coverage of excised full-thickness burns, but is also very expensive and requires additional personnel and major storage spaces in comparison to other products. The purpose of this study is to determine the extent to which PermeaDerm® dressing promotes wound bed maturation when used as a temporary dressing for excised full-thickness burn wounds. Efficacy and safety in promoting wound bed maturation for successive autografting will be determined through direct comparison to FHCA.

Detailed Description
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In this prospective, randomized, matched design pilot study, we aim to compare the current standard of care FHCA to PermeaDerm®. 30 patients for each study arm (n total = 60) meeting the inclusion criteria will be enrolled to randomly receive FHCA and PermeaDerm® on two adjacent or symmetric body areas. Prior to randomization of study areas and application of study dressings, baseline assessments of wound size and burn depth will be performed by the experienced physician and documented using photography and when indicated laser Doppler (Moor Laser Speckle®, Moor Instruments, Devon, UK) measurements. Percentage of graft take and wound healing after removal of the temporary wound dressings and secondary autografting (study arm 1) or after excision and direct autografting with wiedely-meshed autograft and temporary wound dressings as overlay (study arm 2) will be assessed. Secondary outcomes will include complications such as infections, signs of rejection/non-adherence, fluid accumulation/hematoma beneath dressings and mid- and long-term clinical scar maturation, as assessed by the POSAS and objectively with the DermaLab Combo® device (Cortex Technology ApS, Hadsund, Denmark).

Official Title
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Biosynthetic Skin Substitute Versus Frozen Human Cadaver Allograft for Temporary Coverage of Excised Full-thickness Burn Wounds

Conditions
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Full Thickness Burn

Intervention / Treatment
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* Device: PermeaDerm for temporary coverage
* Device: FHCA for temporary coverage
* Device: PermeaDerm over autograft
* Device: FHCA over autograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 2 % total body surface area (TBSA) full thickness burned. Patients with two adjacent or body symmetrical full thickness burned areas (each ≥ 1 TBSA) and comparable in size (TBSA ± 0.5), that require debridement and autografting. Exclusion Criteria: Time from injury to admission >= 5 days Sepsis on admission or clinically suspected infection (as per attending physician) Pregnancy or childbearing Positive HIV or hepatitis screens History of active malignancy Patients who do not require surgical debridement and autografting Patient with burn injuries originating from other causes (chemical, and frostbite)

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized matched design with application of both study dressings symmetrical or adjacent body sites at the same time.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Permeaderm as temporary coverage<br>A: temporary coverage with PermeaDerm until autografting: After randomization of study site, study dressing will be applied as temporary coverage on freshly excised full-thickness burn wounds. | Device: PermeaDerm for temporary coverage<br>* See above<br>|
| Active Comparator: FHCA as temporary coverage<br>B: temporary coverage with FHCA until autografting: After randomization of study site, study dressing will be applied as temporary coverage on freshly excised full-thickness burn wounds. | Device: FHCA for temporary coverage<br>* See above<br>|
| Experimental: Permeaderm over widely meshed autograft<br>C: temporary coverage of widely meshed autograft with PermeaDerm until healing occurs and PermeaDerm can remove | Device: PermeaDerm over autograft<br>* See above<br>|
| Active Comparator: FHCA over widely meshed autograft<br>D: temporary coverage of widely meshed autograft with FHCA until healing occurs | Device: FHCA over autograft<br>* see above<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to heal | Time until study areas are 95% healed, as rated by blinded assessors based on photographs | up to 8 weeks after initial grafting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adherence problems (Arm 2) | % of non-adherence at first dressing change | up to 21 days after initial surgery | 
| Incidence of adherence problems (Arm 1) | % of non-adherence at first dressing change and at time of dressing removal before grafting | up to 21 days after initial surgery | 
| Incidence of infections | Incidence of infection, defined as >10x5 bacteria/g tissue, Only taken when infection suspected. | up to 8 weeks after initial grafting | 
| Rate of fluid/hematoma accumulation | % of fluid accumulation/hematoma formation at first dressing change | up to 21 days after initial surgery | 
| Cost effectiveness | Price per cm square of each study dressing | Until grafting of study sites, within 21 days | 
| Scar assessment with Patient and Observer Assessment Scale (POSAS) | Using Patient and Observer Scar Assessment Scale POSAS, what is a composite score that is rating the overall appearance of the scar, based on each single score for rating vascularity, pigmentation, thickness, relief, pliability, surface. Every subscore ranges from 1-10. The composite score is calculated as an average of the subscores. Higher numbers mean worse scarring. | Assessed within 4 weeks after 95% wound healing | 
| Scar assessment with Patient and Observer Assessment Scale (POSAS) | Using Patient and Observer Scar Assessment Scale POSAS, what is a composite score that is rating the overall appearance of the scar, based on each single score for rating vascularity, pigmentation, thickness, relief, pliability, surface. Every subscore ranges from 1-10. The composite score is calculated as an average of the subscores. Higher numbers mean worse scarring. | Assessed between 3 and 9 months after initial admission | 
| Scar assessment with Patient and Observer Assessment Scale (POSAS) | Using Patient and Observer Scar Assessment Scale POSAS, what is a composite score that is rating the overall appearance of the scar, based on each single score for rating vascularity, pigmentation, thickness, relief, pliability, surface. Every subscore ranges from 1-10. The composite score is calculated as an average of the subscores. Higher numbers mean worse scarring. | Assessed between 9-15 months after initial admission | 
| Scarring with DermaLab Combo device: Viscoelasticity | Measured through negative suction and retraction time. | Assessed within 4 weeks after 95% wound healing | 
| Scarring with DermaLab Combo device: Viscoelasticity | Measured through negative suction and retraction time. | Assessed between 3 and 9 months after initial admission | 
| Scarring with DermaLab Combo device: Viscoelasticity | Measured through negative suction and retraction time. | Assessed between 9-15 months after initial admission | 
| Scarring with DermaLab Combo device: Hydration | Measured based on skin conductance. | Assessed within 4 weeks after 95% wound healing | 
| Scarring with DermaLab Combo device: Hydration | Measured based on skin conductance. | Assessed between 3 and 9 months after initial admission | 
| Scarring with DermaLab Combo device: Hydration | Measured based on skin conductance. | Assessed between 9-15 months after initial admission | 
| Scarring with DermaLab Combo device: Pigmentation | Measured based on light absorption of melanin and erythema | Assessed within 4 weeks after 95% wound healing | 
| Scarring with DermaLab Combo device: Pigmentation | Measured based on light absorption of melanin and erythema | Assessed between 3 and 9 months after initial admission | 
| Scarring with DermaLab Combo device: Pigmentation | Measured based on light absorption of melanin and erythema | Assessed between 9-15 months after initial admission | 
| Scarring with DermaLab Combo device: Trans epithermal water loss | Measuring evaporation in g/meter square/hour | Assessed within 4 weeks after 95% wound healing | 
| Scarring with DermaLab Combo device: Trans epithermal water loss | Measuring evaporation in g/meter square/hour | Assessed between 3 and 9 months after initial admission | 
| Scarring with DermaLab Combo device: Trans epithermal water loss | Measuring evaporation in g/meter square/hour | Assessed between 9-15 months after initial admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PermeaDerm, Cadaver skin, full thickness burn, temporary coverage