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Unable to continue study following Hurricane Ike.
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The purpose of this study is to determine if using a DERMAL LAYER under skin grafts:
Compare scarring outcome of Dermal products
Various skin substitutes are compared for healing, scar and functional and cosmetic outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alloderm, Integra, Homograft, Autograft | Experimental | Burn debridement and grafting using interventions of 1) AlloDerm, 2) Integra, 3) Homograft and 4) Autograft on four separate sites on each patient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integra | Procedure | Grafting using the Commercial product Integra as a skin substitute over full thickness burn following excision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years post burn injury |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David N Herndon, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch, Galveston | Galveston | Texas | 77555 | United States | ||
| University of Texas Medical Branch |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alloderm, Integra, Homograft, Autograft | Grafting with alloderm, Integra, Homograft, and/or Autograft on each patient. Different sites were then compared. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alloderm, Integra, Homograft, and/or Autograft | Grafting with alloderm, integra, homograft and/or autograft. Various treatment sites were then compared. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Each site grafted with a skin substitute was analyzed with a Scar Assessment | Posted | Mean | Standard Deviation | units on a scale | 2 years post burn injury |
|
1997-2011
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AlloDerm, Integra, Homograft, Autograft | Skin product used on each of the four test sites on each patient |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aspiration and Death | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | 2001: Following discharge from hospital, patient aspirated while sleeping. Advanced Cardiac Life Support provided however patient expired. PI felt Adverse Event not related to study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Vascular disorders | Non-systematic Assessment | 2003: Hematoma following femoral IV line placement. PI opinion is Adverse Event is not related to study. 2006: hematoma developed following femoral IV line placement. PI opinion is Adverse Event is not related to study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Herndon, MD | University of Texas Medical Branch | 409-770-6731 | dherndon@utmb.edu |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C114835 | integra artificial skin |
| C440568 | Alloderm |
| D014184 | Transplantation, Homologous |
| D014182 | Transplantation, Autologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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|
| AlloDerm | Procedure | Grafting using the commercial product AlloDerm as a skin substitute |
|
|
| Homograft | Procedure | Grafting using homograft as a skin substitute |
|
|
| Autograft | Procedure | grafting using patients own skin from a separate donor site |
|
| Galveston |
| Texas |
| 77555 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Integra |
Surgery with Integra grafting followed with autografting |
| OG002 | Homograft | Surgery using Homograft followed with autografting |
| OG003 | Autograft | Surgery with Autografting |
|
|
|
| 9 |
| 158 |
| 3 |
| 158 |
|
| Invasive infection and death | Infections and infestations | Systematic Assessment | 2001: 74% burn admitted with invasive infection. Developed multi organ failure,, coded and expired. Patient never started study. PI stated Adverse Event not related to study. |
|
| 90% burn admitted with renal failure, died | Renal and urinary disorders | Systematic Assessment | 2001: 90% burn admitted with renal failure. After most of burns were grafted, renal failure worsened, patient eventually died. PI stated unlikely related to study. |
|
| leg ischemia | Vascular disorders | Non-systematic Assessment | 2001: Arterial line placed for surgical procedure, right leg became ischemic. Treated with anticoagulants. No long term complications. PI stated not related to study. |
|
| Invasive infection, Multi organ failure, death | Infections and infestations | Systematic Assessment | 2001: 85% burn patient admitted with invasive infection. Developed sepsis, renal failure, multi organ failure. Patient allowed to die. |
|
| Respiratory status compromised | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | 2001: Chest tube pulled out. PI stated not related to study. 2001: Plugged Endotracheal tube x2. Endotracheal Tube pulled and replaced. PI opinion is Adverse Event is not related to study. |
|
| hypoglycemia | Endocrine disorders | Non-systematic Assessment | 2001 Patient on insulin drip, glucose decreased to 35. Glucose treated,Insulin stopped. PI opinion:not related to study. 2001: Patient on insulin drip. Glucose decreased to 30. Patient treated, insulin stopped. PI opinion:not related to study. |
|
|
| Fall and open wound | Skin and subcutaneous tissue disorders | Non-systematic Assessment | 2001: Patient fell trying to push chair and ripped skin open. |
|
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