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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
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University of texas Medical Branch Galveston
Galveston, Texas, United States
Time to heal
Time until study areas are 95% healed, as rated by blinded assessors based on photographs
Time frame: up to 8 weeks after initial grafting
Incidence of adherence problems (Arm 2)
% of non-adherence at first dressing change
Time frame: 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
Time frame: up to 21 days after initial surgery
Incidence of infections
Incidence of infection, defined as \>10x5 bacteria/g tissue, Only taken when infection suspected.
Time frame: up to 8 weeks after initial grafting
Rate of fluid/hematoma accumulation
% of fluid accumulation/hematoma formation at first dressing change
Time frame: up to 21 days after initial surgery
Cost effectiveness
Price per cm square of each study dressing
Time frame: 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.
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see above
Time frame: 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.
Time frame: 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.
Time frame: Assessed between 9-15 months after initial admission
Scarring with DermaLab Combo device: Viscoelasticity
Measured through negative suction and retraction time.
Time frame: Assessed within 4 weeks after 95% wound healing
Scarring with DermaLab Combo device: Viscoelasticity
Measured through negative suction and retraction time.
Time frame: Assessed between 3 and 9 months after initial admission
Scarring with DermaLab Combo device: Viscoelasticity
Measured through negative suction and retraction time.
Time frame: Assessed between 9-15 months after initial admission
Scarring with DermaLab Combo device: Hydration
Measured based on skin conductance.
Time frame: Assessed within 4 weeks after 95% wound healing
Scarring with DermaLab Combo device: Hydration
Measured based on skin conductance.
Time frame: Assessed between 3 and 9 months after initial admission
Scarring with DermaLab Combo device: Hydration
Measured based on skin conductance.
Time frame: Assessed between 9-15 months after initial admission
Scarring with DermaLab Combo device: Pigmentation
Measured based on light absorption of melanin and erythema
Time frame: Assessed within 4 weeks after 95% wound healing
Scarring with DermaLab Combo device: Pigmentation
Measured based on light absorption of melanin and erythema
Time frame: Assessed between 3 and 9 months after initial admission
Scarring with DermaLab Combo device: Pigmentation
Measured based on light absorption of melanin and erythema
Time frame: Assessed between 9-15 months after initial admission
Scarring with DermaLab Combo device: Trans epithermal water loss
Measuring evaporation in g/meter square/hour
Time frame: Assessed within 4 weeks after 95% wound healing
Scarring with DermaLab Combo device: Trans epithermal water loss
Measuring evaporation in g/meter square/hour
Time frame: 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
Time frame: Assessed between 9-15 months after initial admission