Permeaderm Versus Homograft for Full-thickness Burns
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About
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.
Full 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).
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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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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