Burns
Conditions
Keywords
Burns, Skin grafting, AlloDerm, Integra, Homograft, Autograft, Burn Scar
Brief summary
The purpose of this study is to determine if using a DERMAL LAYER under skin grafts: 1. will reduce scar formation of skin grafts 2. will reduce burn wound contractures 3. will improve functional outcome of joints requiring grafts Compare scarring outcome of Dermal products
Detailed description
Various skin substitutes are compared for healing, scar and functional and cosmetic outcomes.
Interventions
PROCEDUREIntegra
Grafting using the Commercial product Integra as a skin substitute over full thickness burn following excision.
PROCEDUREAlloDerm
Grafting using the commercial product AlloDerm as a skin substitute
PROCEDUREHomograft
Grafting using homograft as a skin substitute
PROCEDUREAutograft
grafting using patients own skin from a separate donor site
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 90 Years
Healthy volunteers
No
Inclusion criteria
* Burn injury requiring grafting * 0 years-90 years
Exclusion criteria
* Partial thickness burns only
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Burn Scar Comparison | 2 years post burn injury | Burn scar is measured scar using the Vancouver Scar Scale (range 0-12) for each of the various skin substitutes used in grafting. Vancouver Scar Scale measure burn scarring assessing categories of redness/vascularity, hardness, pigmentation and scar height. Each item has a scale of 0-3. Score for each category is summed together for a total score between 0-12. The total score is generally used in the burn community, therefore the total score will be reported. Lower scores are better; higher scores are worse. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from the Galveston Burn Unit following an acute burn injury that were diagnosed with 3rd degree burns. Study was active between 1997-2011.
Pre-assignment details
Patients were enrolled before their surgical procedure. After consent was obtained. After the surgical site was identified, the site was randomized to receive the various skin products.
Participants by arm
| Arm | Count |
|---|---|
| Alloderm, Integra, Homograft, and/or Autograft Grafting with alloderm, integra, homograft and/or autograft. Various treatment sites were then compared. | 158 |
| Total | 158 |
Baseline characteristics
| Characteristic | Alloderm, Integra, Homograft, and/or Autograft |
|---|---|
| Age, Categorical <=18 years | 158 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 158 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 158 |
| serious Total, serious adverse events | 9 / 158 |
Outcome results
Primary
Burn Scar Comparison
Burn scar is measured scar using the Vancouver Scar Scale (range 0-12) for each of the various skin substitutes used in grafting. Vancouver Scar Scale measure burn scarring assessing categories of redness/vascularity, hardness, pigmentation and scar height. Each item has a scale of 0-3. Score for each category is summed together for a total score between 0-12. The total score is generally used in the burn community, therefore the total score will be reported. Lower scores are better; higher scores are worse.
Time frame: 2 years post burn injury
Population: Each site grafted with a skin substitute was analyzed with a Scar Assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AlloDerm | Burn Scar Comparison | Scar Score 6 months post burn | 10.7 units on a scale | Standard Deviation 1 |
| AlloDerm | Burn Scar Comparison | Scar Score 24 months post burn | 5.7 units on a scale | Standard Deviation 0.9 |
| Integra | Burn Scar Comparison | Scar Score 24 months post burn | 4.7 units on a scale | Standard Deviation 0.8 |
| Integra | Burn Scar Comparison | Scar Score 6 months post burn | 6.9 units on a scale | Standard Deviation 1.4 |
| Homograft | Burn Scar Comparison | Scar Score 6 months post burn | 12.0 units on a scale | Standard Deviation 1.8 |
| Homograft | Burn Scar Comparison | Scar Score 24 months post burn | 4.8 units on a scale | Standard Deviation 0.7 |
| Autograft | Burn Scar Comparison | Scar Score 6 months post burn | 11.6 units on a scale | Standard Deviation 0.8 |
| Autograft | Burn Scar Comparison | Scar Score 24 months post burn | 5.6 units on a scale | Standard Deviation 0.8 |
Comparison: We conducted a multiple four group comparison (all pairwise comparisons were conducted). An Anova was conducted to assess statistical significance.p-value: 0.05ANOVA