Full Thickness Burn
Conditions
Keywords
PermeaDerm, Cadaver skin, full thickness burn, temporary coverage
Brief summary
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
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).
Interventions
DEVICEPermeaDerm for temporary coverage
See above
DEVICEFHCA for temporary coverage
See above
DEVICEPermeaDerm over autograft
See above
DEVICEFHCA over autograft
see above
Sponsors
Shriners Hospitals for Children
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessors (healing time and scar assessments) are blinded.
Intervention model description
Randomized matched design with application of both study dressings symmetrical or adjacent body sites at the same time.
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to heal | up to 8 weeks after initial grafting | Time until study areas are 95% healed, as rated by blinded assessors based on photographs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scarring with DermaLab Combo device: Viscoelasticity | Assessed within 4 weeks after 95% wound healing | Measured through negative suction and retraction time. |
| Scarring with DermaLab Combo device: Hydration | Assessed within 4 weeks after 95% wound healing | Measured based on skin conductance. |
| Scarring with DermaLab Combo device: Pigmentation | Assessed within 4 weeks after 95% wound healing | Measured based on light absorption of melanin and erythema |
| Scarring with DermaLab Combo device: Trans epithermal water loss | Assessed within 4 weeks after 95% wound healing | Measuring evaporation in g/meter square/hour |
| Scar assessment with Patient and Observer Assessment Scale (POSAS) | Assessed within 4 weeks after 95% wound healing | 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. |
| Incidence of adherence problems (Arm 1) | up to 21 days after initial surgery | % of non-adherence at first dressing change and at time of dressing removal before grafting |
| Incidence of infections | up to 8 weeks after initial grafting | Incidence of infection, defined as \>10x5 bacteria/g tissue, Only taken when infection suspected. |
| Rate of fluid/hematoma accumulation | up to 21 days after initial surgery | % of fluid accumulation/hematoma formation at first dressing change |
| Cost effectiveness | Until grafting of study sites, within 21 days | Price per cm square of each study dressing |
| Incidence of adherence problems (Arm 2) | up to 21 days after initial surgery | % of non-adherence at first dressing change |
Countries
United States
Outcome results
None listed