Clinical trial NCT04673435: Permeaderm Versus Homograft for Full-thickness Burns
Official title: Biosynthetic Skin Substitute Versus Frozen Human Cadaver Allograft for Temporary Coverage of Excised Full-thickness Burn Wounds
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Full Thickness Burn
Keywords: PermeaDerm
Cadaver skin
full thickness burn
temporary coverage
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: Shriners Hospitals for Children
First posted: 2020-12-17
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized matched design with application of both study dressings symmetrical or adjacent body sites at the same time.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Time to heal
timeFrame: up to 8 weeks after initial grafting
Secondary outcomes:
measure: Incidence of adherence problems (Arm 2)
timeFrame: up to 21 days after initial surgery
measure: Incidence of adherence problems (Arm 1)
timeFrame: up to 21 days after initial surgery
measure: Incidence of infections
timeFrame: up to 8 weeks after initial grafting
measure: Rate of fluid/hematoma accumulation
timeFrame: up to 21 days after initial surgery
measure: Cost effectiveness
timeFrame: Until grafting of study sites, within 21 days
measure: Scar assessment with Patient and Observer Assessment Scale (POSAS)
timeFrame: Assessed within 4 weeks after 95% wound healing
measure: Scar assessment with Patient and Observer Assessment Scale (POSAS)
timeFrame: Assessed between 3 and 9 months after initial admission
measure: Scar assessment with Patient and Observer Assessment Scale (POSAS)
timeFrame: Assessed between 9-15 months after initial admission
measure: Scarring with DermaLab Combo device: Viscoelasticity
timeFrame: Assessed within 4 weeks after 95% wound healing
measure: Scarring with DermaLab Combo device: Viscoelasticity
timeFrame: Assessed between 3 and 9 months after initial admission
measure: Scarring with DermaLab Combo device: Viscoelasticity
timeFrame: Assessed between 9-15 months after initial admission
measure: Scarring with DermaLab Combo device: Hydration
timeFrame: Assessed within 4 weeks after 95% wound healing
measure: Scarring with DermaLab Combo device: Hydration
timeFrame: Assessed between 3 and 9 months after initial admission
measure: Scarring with DermaLab Combo device: Hydration
timeFrame: Assessed between 9-15 months after initial admission
measure: Scarring with DermaLab Combo device: Pigmentation
timeFrame: Assessed within 4 weeks after 95% wound healing
measure: Scarring with DermaLab Combo device: Pigmentation
timeFrame: Assessed between 3 and 9 months after initial admission
measure: Scarring with DermaLab Combo device: Pigmentation
timeFrame: Assessed between 9-15 months after initial admission
measure: Scarring with DermaLab Combo device: Trans epithermal water loss
timeFrame: Assessed within 4 weeks after 95% wound healing
measure: Scarring with DermaLab Combo device: Trans epithermal water loss
timeFrame: Assessed between 3 and 9 months after initial admission
measure: Scarring with DermaLab Combo device: Trans epithermal water loss
timeFrame: Assessed between 9-15 months after initial admission
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of texas Medical Branch Galveston
state: Texas
Study officials:
affiliation: The University of Texas Medical Branch, Galveston
name: David N Herndon, MD
role: PRINCIPAL_INVESTIGATOR
References: