Trial Outcomes & Findings for StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements (NCT NCT03005106)
NCT ID: NCT03005106
Last Updated: 2021-07-14
Results Overview
Percent area autografted by Month 3 is the sum of the percent areas at each study session/visit, up to and including Study Session 7/Month 3 (± 14 d).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
71 participants
Primary outcome timeframe
3 Months
Results posted on
2021-07-14
Participant Flow
Participant milestones
| Measure |
All Participants
StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).
Autograft: The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound.
|
|---|---|
|
Overall Study
STARTED
|
71
|
|
Overall Study
Completed Month 3 Visit
|
64
|
|
Overall Study
Completed Month 12 Visit
|
51
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
All Participants
StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).
Autograft: The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
16
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Death
|
2
|
Baseline Characteristics
StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements
Baseline characteristics by cohort
| Measure |
All Participants
n=71 Participants
StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).
Autograft: The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
45 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 MonthsPopulation: Modified Intent to Treat Population
Percent area autografted by Month 3 is the sum of the percent areas at each study session/visit, up to and including Study Session 7/Month 3 (± 14 d).
Outcome measures
| Measure |
All Participants
n=71 Participants
StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).
Autograft: The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound.
|
|---|---|
|
Percent Area of Treatment Sites Requiring Autografting by Month 3
StrataGraft (Treatment) Sites
|
4.33 percentage of treatment sites
Standard Deviation 21.58
|
|
Percent Area of Treatment Sites Requiring Autografting by Month 3
Autograft (Control) Sites
|
102.10 percentage of treatment sites
Standard Deviation 13.14
|
PRIMARY outcome
Timeframe: Month 3Population: Modified Intent to Treat Population
Wound closure of the treatment site was defined as complete skin re-epithelialization and the absence of drainage. A participant whose StrataGraft treatment site achieves durable wound closure without autograft placement is classified as a responder.
Outcome measures
| Measure |
All Participants
n=71 Participants
StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).
Autograft: The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound.
|
|---|---|
|
Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3)
|
59 Participants
|
SECONDARY outcome
Timeframe: Day 3, Day 7 and Day 14, average of the 3 days reportedPopulation: Modified Intent to Treat
Pain scores from the FACES scale range from 0 (no pain) to 5 (worst pain). Pain scores from Day 3, Day 7, and Day 14 (where available) are averaged for the summary statistics.
Outcome measures
| Measure |
All Participants
n=71 Participants
StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).
Autograft: The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound.
|
|---|---|
|
Pain at the Designated Donor Sites by Day 14
StrataGraft (Treatment)
|
0.15 score on a scale
Standard Deviation 0.54
|
|
Pain at the Designated Donor Sites by Day 14
Autograft (Control)
|
2.55 score on a scale
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: at Month 3Population: Maximum number of participants with data at Month 3 in the modified Intent to Treat population
Total Score is the sum of the scores for vascularization, pigmentation, thickness, relief, pliability, and surface area. For each of the 6 assessment categories, the scale ranged from 1=normal skin to 10=worst scar imaginable, with the highest possible score of 10. A higher score indicates worse scarring, so the best possible total score for the 6 categories is 6, and the worst possible score is 60.
Outcome measures
| Measure |
All Participants
n=61 Participants
StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).
Autograft: The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound.
|
|---|---|
|
Total Scar Assessment (POSAS) Score by Observer at Month 3
StrataGraft (Treatment)
|
6.3 score on a scale
Standard Deviation 1.71
|
|
Total Scar Assessment (POSAS) Score by Observer at Month 3
Autograft (Control)
|
16.3 score on a scale
Standard Deviation 7.71
|
Adverse Events
All Participants
Serious events: 10 serious events
Other events: 49 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
All Participants
n=71 participants at risk
StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).
Autograft: The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound.
|
|---|---|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
1.4%
1/71 • Number of events 1 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Nervous system disorders
Seizure
|
1.4%
1/71 • Number of events 1 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Psychiatric disorders
Hallucination
|
1.4%
1/71 • Number of events 1 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.4%
1/71 • Number of events 1 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Vascular disorders
Deep vein thrombosis
|
1.4%
1/71 • Number of events 1 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Vascular disorders
Migraine
|
1.4%
1/71 • Number of events 1 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Cardiac disorders
Acute left ventricular failure
|
1.4%
1/71 • Number of events 1 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.4%
1/71 • Number of events 2 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/71 • Number of events 1 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Cardiac disorders
Bundle branch block left
|
1.4%
1/71 • Number of events 1 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
1/71 • Number of events 1 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
General disorders
Concomitant disease progression
|
1.4%
1/71 • Number of events 1 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
General disorders
Death
|
1.4%
1/71 • Number of events 1 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
General disorders
Malaise
|
1.4%
1/71 • Number of events 1 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
General disorders
Pyrexia
|
1.4%
1/71 • Number of events 1 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Infections and infestations
Enterobacter bacteraemia
|
1.4%
1/71 • Number of events 1 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Infections and infestations
Pneumonia bacterial
|
1.4%
1/71 • Number of events 1 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
1.4%
1/71 • Number of events 1 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Infections and infestations
Sepsis
|
1.4%
1/71 • Number of events 2 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
Other adverse events
| Measure |
All Participants
n=71 participants at risk
StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).
Autograft: The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
4/71 • Number of events 4 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Gastrointestinal disorders
Constipation
|
12.7%
9/71 • Number of events 9 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Gastrointestinal disorders
Nausea
|
7.0%
5/71 • Number of events 5 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
General disorders
Pain
|
11.3%
8/71 • Number of events 8 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
General disorders
Pyrexia
|
5.6%
4/71 • Number of events 4 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Injury, poisoning and procedural complications
Donor site complication
|
7.0%
5/71 • Number of events 6 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.5%
6/71 • Number of events 6 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Nervous system disorders
Neuralgia
|
9.9%
7/71 • Number of events 7 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Psychiatric disorders
Insomnia
|
7.0%
5/71 • Number of events 5 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Skin and subcutaneous tissue disorders
Blister
|
14.1%
10/71 • Number of events 12 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
5.6%
4/71 • Number of events 4 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Skin and subcutaneous tissue disorders
Hypertrophic scar
|
15.5%
11/71 • Number of events 12 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
35.2%
25/71 • Number of events 29 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
4/71 • Number of events 4 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
|
Vascular disorders
Hypertension
|
8.5%
6/71 • Number of events 6 • Through the 12-month follow-up
Only Treatment-Emergent Adverse Events (TEAEs) were used for the non-serious adverse events table.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place