Trial Outcomes & Findings for Comparison of Skin Substitutes Used in Burn Care (NCT NCT00676013)
NCT ID: NCT00676013
Last Updated: 2019-12-16
Results Overview
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.
TERMINATED
NA
158 participants
2 years post burn injury
2019-12-16
Participant Flow
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.
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.
Participant milestones
| Measure |
Alloderm, Integra, Homograft, Autograft
Grafting with alloderm, Integra, Homograft, and/or Autograft on each patient. Different sites were then compared.
|
|---|---|
|
Overall Study
STARTED
|
158
|
|
Overall Study
COMPLETED
|
157
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Skin Substitutes Used in Burn Care
Baseline characteristics by cohort
| Measure |
Alloderm, Integra, Homograft, and/or Autograft
n=158 Participants
Grafting with alloderm, integra, homograft and/or autograft. Various treatment sites were then compared.
|
|---|---|
|
Age, Categorical
<=18 years
|
158 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
158 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 years post burn injuryPopulation: Each site grafted with a skin substitute was analyzed with a Scar Assessment
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.
Outcome measures
| Measure |
AlloDerm
n=158 Participants
Surgery using alloDerm. Various treatment sites were then compared.
|
Integra
n=158 Participants
Surgery with Integra grafting followed with autografting
|
Homograft
n=158 Participants
Surgery using Homograft followed with autografting
|
Autograft
n=158 Participants
Surgery with Autografting
|
|---|---|---|---|---|
|
Burn Scar Comparison
Scar Score 6 months post burn
|
10.7 units on a scale
Standard Deviation 1.0
|
6.9 units on a scale
Standard Deviation 1.4
|
12.0 units on a scale
Standard Deviation 1.8
|
11.6 units on a scale
Standard Deviation .8
|
|
Burn Scar Comparison
Scar Score 24 months post burn
|
5.7 units on a scale
Standard Deviation .9
|
4.7 units on a scale
Standard Deviation .8
|
4.8 units on a scale
Standard Deviation .7
|
5.6 units on a scale
Standard Deviation .8
|
Adverse Events
AlloDerm, Integra, Homograft, Autograft
Serious adverse events
| Measure |
AlloDerm, Integra, Homograft, Autograft
n=158 participants at risk
Skin product used on each of the four test sites on each patient
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Aspiration and Death
|
0.63%
1/158 • Number of events 1 • 1997-2011
|
|
Infections and infestations
Invasive infection and death
|
0.63%
1/158 • Number of events 1 • 1997-2011
|
|
Renal and urinary disorders
90% burn admitted with renal failure, died
|
0.63%
1/158 • Number of events 1 • 1997-2011
|
|
Vascular disorders
leg ischemia
|
0.63%
1/158 • Number of events 1 • 1997-2011
|
|
Infections and infestations
Invasive infection, Multi organ failure, death
|
0.63%
1/158 • Number of events 1 • 1997-2011
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory status compromised
|
1.3%
2/158 • Number of events 2 • 1997-2011
|
|
Endocrine disorders
hypoglycemia
|
1.3%
2/158 • Number of events 2 • 1997-2011
|
Other adverse events
| Measure |
AlloDerm, Integra, Homograft, Autograft
n=158 participants at risk
Skin product used on each of the four test sites on each patient
|
|---|---|
|
Skin and subcutaneous tissue disorders
Fall and open wound
|
0.63%
1/158 • Number of events 1 • 1997-2011
|
|
Vascular disorders
Hematoma
|
1.3%
2/158 • Number of events 2 • 1997-2011
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place