Permeaderm Versus Homograft for Full-thickness Burns
- Conditions
- Full Thickness Burn
- Interventions
- Device: PermeaDerm over autograftDevice: FHCA over autograftDevice: FHCA for temporary coverageDevice: PermeaDerm for temporary coverage
- Registration Number
- NCT04673435
- 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).
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- ≥ 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Permeaderm over widely meshed autograft PermeaDerm over autograft C: temporary coverage of widely meshed autograft with PermeaDerm until healing occurs and PermeaDerm can remove FHCA over widely meshed autograft FHCA over autograft D: temporary coverage of widely meshed autograft with FHCA until healing occurs FHCA as temporary coverage FHCA for temporary coverage 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. Permeaderm as temporary coverage PermeaDerm for temporary coverage 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Rate of fluid/hematoma accumulation up to 21 days after initial surgery % of fluid accumulation/hematoma formation at first dressing change
Scarring with DermaLab Combo device: Viscoelasticity Assessed between 9-15 months after initial admission Measured through negative suction and retraction time.
Scarring with DermaLab Combo device: Trans epithermal water loss Assessed between 9-15 months after initial admission Measuring evaporation in g/meter square/hour
Incidence of adherence problems (Arm 2) up to 21 days after initial surgery % of non-adherence at first dressing change
Incidence of infections up to 8 weeks after initial grafting Incidence of infection, defined as \>10x5 bacteria/g tissue, Only taken when infection suspected.
Scarring with DermaLab Combo device: Pigmentation Assessed between 9-15 months after initial admission Measured based on light absorption of melanin and erythema
Cost effectiveness Until grafting of study sites, within 21 days Price per cm square of each study dressing
Scar assessment with Patient and Observer Assessment Scale (POSAS) Assessed between 9-15 months after initial admission 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.
Scarring with DermaLab Combo device: Hydration Assessed between 9-15 months after initial admission Measured based on skin conductance.
Trial Locations
- Locations (1)
University of texas Medical Branch Galveston
🇺🇸Galveston, Texas, United States