Trial Outcomes & Findings for Assessment of Safety and Effectiveness of Biodegradable Temporizing Matrix in the Treatment of Deep Burn Skin Injuries (NCT NCT02905435)
NCT ID: NCT02905435
Last Updated: 2021-06-08
Results Overview
Percentage of total body surface area (%TBSA) of BTM that has adhered at time of skin grafting, divided by the %TBSA treated with BTM, then multiplied by 100 to express as a percentage. Calculated per study lesion and averaged per participant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
At time of application of split skin graft (SSG) (typically 28-35 days after application of BTM, Day 0)
Results posted on
2021-06-08
Participant Flow
Only participants (or their legally authorized representatives) who provided written informed consent and who met the eligibility criteria were enrolled and had BTM applied to the study lesions. Participants (or their legally authorized representatives) who provided informed consent but who did not meet the eligibility criteria were excluded and did not have BTM applied.
Participant milestones
| Measure |
Biodegradable Temporizing Matrix
Biodegradable Temporizing Matrix (BTM)
Biodegradable Temporizing Matrix: The Biodegradable Temporizing Matrix (BTM) (also known as BTM Dressing) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
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|---|---|
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Overall Study
STARTED
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14
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Overall Study
COMPLETED
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7
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Overall Study
NOT COMPLETED
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7
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Reasons for withdrawal
| Measure |
Biodegradable Temporizing Matrix
Biodegradable Temporizing Matrix (BTM)
Biodegradable Temporizing Matrix: The Biodegradable Temporizing Matrix (BTM) (also known as BTM Dressing) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
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|---|---|
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Overall Study
Death
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2
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Overall Study
Physician Decision
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1
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Overall Study
Lost to Follow-up
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4
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Baseline Characteristics
Assessment of Safety and Effectiveness of Biodegradable Temporizing Matrix in the Treatment of Deep Burn Skin Injuries
Baseline characteristics by cohort
| Measure |
Biodegradable Temporizing Matrix
n=14 Participants
Biodegradable Temporizing Matrix (BTM)
Biodegradable Temporizing Matrix: The Biodegradable Temporizing Matrix (BTM) (also known as BTM Dressing) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
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|---|---|
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Age, Continuous
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43.7 years
STANDARD_DEVIATION 15.23 • n=5 Participants
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Sex: Female, Male
Female
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5 Participants
n=5 Participants
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Sex: Female, Male
Male
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9 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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12 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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2 Participants
n=5 Participants
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|
Race (NIH/OMB)
White
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8 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Unknown or Not Reported
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4 Participants
n=5 Participants
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Region of Enrollment
United States
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14 participants
n=5 Participants
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Height
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174.1 centimetres
STANDARD_DEVIATION 10.4 • n=5 Participants
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Weight
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93.0 kilograms
STANDARD_DEVIATION 26.8 • n=5 Participants
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Body Mass Index (BMI)
|
30.8 kilograms/metre^2
STANDARD_DEVIATION 8.3 • n=5 Participants
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Fitzpatrick Skin Type
Type I
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0 Participants
n=5 Participants
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|
Fitzpatrick Skin Type
Type II
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2 Participants
n=5 Participants
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Fitzpatrick Skin Type
Type III
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7 Participants
n=5 Participants
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|
Fitzpatrick Skin Type
Type IV
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1 Participants
n=5 Participants
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Fitzpatrick Skin Type
Type V
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1 Participants
n=5 Participants
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Fitzpatrick Skin Type
Unknown
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3 Participants
n=5 Participants
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Burn Etiology
Thermal
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13 Participants
n=5 Participants
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Burn Etiology
Other (Contact)
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1 Participants
n=5 Participants
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% Total Body Surface Area (TBSA) affected by deep dermal/full thickness burn injury
|
45.1 Percentage of total body surface area
n=5 Participants
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PRIMARY outcome
Timeframe: At time of application of split skin graft (SSG) (typically 28-35 days after application of BTM, Day 0)Population: Intention to treat
Percentage of total body surface area (%TBSA) of BTM that has adhered at time of skin grafting, divided by the %TBSA treated with BTM, then multiplied by 100 to express as a percentage. Calculated per study lesion and averaged per participant.
Outcome measures
| Measure |
Biodegradable Temporizing Matrix (BTM)
n=12 Participants
The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
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|---|---|
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BTM 'Take' Rate
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95.22 percentage of BTM take per subject
Standard Deviation 7.175
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PRIMARY outcome
Timeframe: 7-10 days after application of SSGPopulation: Intention to treat
The amount (calculated as a percentage) of split skin graft (SSG) that 'takes' expressed as a proportion of SSG applied at 7-10 days after application of SSG. Calculated per study lesion and averaged for each participant.
Outcome measures
| Measure |
Biodegradable Temporizing Matrix (BTM)
n=11 Participants
The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
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|---|---|
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SSG 'Take' Rate Over BTM
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97.53 percentage of SSG take per subject
Standard Deviation 7.501
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PRIMARY outcome
Timeframe: All timepoints until 12 months after application of SSGPopulation: Intention to treat
Number and type of Adverse Events occurring after BTM implantation
Outcome measures
| Measure |
Biodegradable Temporizing Matrix (BTM)
n=14 Participants
The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
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|---|---|
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Adverse Events
Any adverse event
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340 adverse events
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Adverse Events
Any adverse event leading to treatment discontinuation
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3 adverse events
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Adverse Events
Any NCI CTCAE Grade 3 or higher adverse event
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8 adverse events
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Adverse Events
Any device-related adverse event
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3 adverse events
|
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Adverse Events
Any serious adverse event (SAE)
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6 adverse events
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Adverse Events
Any adverse event leading to death
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2 adverse events
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Adverse Events
Any unanticipated adverse device effect (UADE) adverse event
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0 adverse events
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SECONDARY outcome
Timeframe: From day of application (Day 0) until 12 months after SSG.Incidence of infections in BTM-treated areas, and the success of treatment of local infections with BTM in place. Results will be combined and expressed as local infection rate and response rate to treatment.
Outcome measures
| Measure |
Biodegradable Temporizing Matrix (BTM)
n=33 Wounds treated with BTM
The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
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|---|---|
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Infection
Not infected
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21 Wounds treated with BTM
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Infection
Infected
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12 Wounds treated with BTM
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Infection
Infected - study device retained
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7 Wounds treated with BTM
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Infection
Infected - study device partially removed
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2 Wounds treated with BTM
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Infection
Infected - study device totally removed
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3 Wounds treated with BTM
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SECONDARY outcome
Timeframe: 1, 2, 3, 6, 12 months after application of SSGPopulation: Intention to treat
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Outcome measures
| Measure |
Biodegradable Temporizing Matrix (BTM)
n=5 Wounds treated with BTM
The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
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|---|---|
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Wound Closure - Anterior Torso
1 month after SSG
|
99.8 % wound closure
Standard Deviation 0.45
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Wound Closure - Anterior Torso
2 months after SSG
|
99.8 % wound closure
Standard Deviation 0.5
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Wound Closure - Anterior Torso
3 months after SSG
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99.8 % wound closure
Standard Deviation 0.5
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Wound Closure - Anterior Torso
6 months after SSG
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100.0 % wound closure
Standard Deviation 0
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Wound Closure - Anterior Torso
12 months after SSG
|
100 % wound closure
Standard Deviation 0
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SECONDARY outcome
Timeframe: 1, 2, 3, 6, 12 months after application of SSGPopulation: Intention to treat
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Outcome measures
| Measure |
Biodegradable Temporizing Matrix (BTM)
n=5 Wounds treated with BTM
The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
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|---|---|
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Wound Closure - Left Lower Limb
1 month after SSG
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95.8 % wound closure
Standard Deviation 4.27
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Wound Closure - Left Lower Limb
2 months after SSG
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95.8 % wound closure
Standard Deviation 4.27
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Wound Closure - Left Lower Limb
3 months after SSG
|
100 % wound closure
Standard Deviation 0
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Wound Closure - Left Lower Limb
6 months after SSG
|
100 % wound closure
Standard Deviation 0
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Wound Closure - Left Lower Limb
12 months after SSG
|
100 % wound closure
Standard Deviation 0
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SECONDARY outcome
Timeframe: 1, 2, 3, 6, 12 months after application of SSGPopulation: Intention to treat
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Outcome measures
| Measure |
Biodegradable Temporizing Matrix (BTM)
n=3 Wounds treated with BTM
The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
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|---|---|
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Wound Closure - Left Upper Limb
1 month after SSG
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100.0 % wound closure
Standard Deviation 0
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Wound Closure - Left Upper Limb
2 months after SSG
|
100.0 % wound closure
Standard Deviation 0
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Wound Closure - Left Upper Limb
3 months after SSG
|
100.0 % wound closure
Standard Deviation 0
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Wound Closure - Left Upper Limb
6 months after SSG
|
100.0 % wound closure
Standard Deviation 0
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Wound Closure - Left Upper Limb
12 months after SSG
|
100.0 % wound closure
Standard Deviation 0
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SECONDARY outcome
Timeframe: 1, 2, 3, 6, 12 months after application of SSGPopulation: Intention to treat
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Outcome measures
| Measure |
Biodegradable Temporizing Matrix (BTM)
n=6 Wounds treated with BTM
The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
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|---|---|
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Wound Closure - Posterior Torso
1 month after SSG
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94.8 % wound closure
Standard Deviation 9.84
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Wound Closure - Posterior Torso
2 months after SSG
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95.8 % wound closure
Standard Deviation 8.84
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Wound Closure - Posterior Torso
3 months after SSG
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100.0 % wound closure
Standard Deviation 0
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Wound Closure - Posterior Torso
6 months after SSG
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100.0 % wound closure
Standard Deviation 0
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Wound Closure - Posterior Torso
12 months after SSG
|
99.6 % wound closure
Standard Deviation 0.89
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SECONDARY outcome
Timeframe: 1, 2, 3, 6, 12 months after application of SSGPopulation: Intention to treat
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Outcome measures
| Measure |
Biodegradable Temporizing Matrix (BTM)
n=5 Wounds treated with BTM
The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
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|---|---|
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Wound Closure - Right Lower Limb
1 month after SSG
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96.0 % wound closure
Standard Deviation 4.52
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Wound Closure - Right Lower Limb
2 months after SSG
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96.3 % wound closure
Standard Deviation 4.79
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Wound Closure - Right Lower Limb
3 months after SSG
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99.8 % wound closure
Standard Deviation 0.45
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Wound Closure - Right Lower Limb
6 months after SSG
|
99.8 % wound closure
Standard Deviation 0.50
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Wound Closure - Right Lower Limb
12 months after SSG
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99.7 % wound closure
Standard Deviation 0.58
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SECONDARY outcome
Timeframe: At time of application of SSG (typically 28-35 days after application of BTM, Day 0)Population: Intention to treat
Operator ease of use as determined by physician survey, scored on a 1 to 5 scale, where 1 = strongly agree and 5 = strongly disagree. A higher score means a worse outcome.
Outcome measures
| Measure |
Biodegradable Temporizing Matrix (BTM)
n=33 Wounds treated with BTM
The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
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|---|---|
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Ease of Use: "BTM is Easy to Use"
Site 1
|
2.0 score on a scale
Standard Deviation 0
|
|
Ease of Use: "BTM is Easy to Use"
Site 3
|
1.0 score on a scale
Standard Deviation 0
|
|
Ease of Use: "BTM is Easy to Use"
Site 4
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1.7 score on a scale
Standard Deviation 0.69
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Ease of Use: "BTM is Easy to Use"
Site 5
|
1.0 score on a scale
Standard Deviation 0
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SECONDARY outcome
Timeframe: At time of application of SSG (typically 28-35 days after application of BTM, Day 0)Population: Intention to treat
Operator ease of use as determined by physician survey, scored on a 1 to 5 scale, where 1 = strongly agree and 5 = strongly disagree. A higher score means a worse outcome.
Outcome measures
| Measure |
Biodegradable Temporizing Matrix (BTM)
n=33 Wounds treated with BTM
The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
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|---|---|
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Ease of Use: "BTM is Easy to Apply"
Site 1
|
2.0 score on a scale
Standard Deviation 0
|
|
Ease of Use: "BTM is Easy to Apply"
Site 3
|
1.0 score on a scale
Standard Deviation 0
|
|
Ease of Use: "BTM is Easy to Apply"
Site 4
|
1.8 score on a scale
Standard Deviation 0.94
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|
Ease of Use: "BTM is Easy to Apply"
Site 5
|
1.0 score on a scale
Standard Deviation 0
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SECONDARY outcome
Timeframe: At time of application of SSG (typically 28-35 days after application of BTM, Day 0)Population: Intention to treat
Operator ease of use as determined by physician survey, scored on a 1 to 5 scale, where 1 = strongly agree and 5 = strongly disagree. A higher score means a worse outcome.
Outcome measures
| Measure |
Biodegradable Temporizing Matrix (BTM)
n=33 Wounds treated with BTM
The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
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|---|---|
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Ease of Use: "BTM is Easy to Delaminate"
Site 1
|
1.0 score on a scale
Standard Deviation 0
|
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Ease of Use: "BTM is Easy to Delaminate"
Site 3
|
1.0 score on a scale
Standard Deviation 0
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|
Ease of Use: "BTM is Easy to Delaminate"
Site 4
|
1.2 score on a scale
Standard Deviation 0.40
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|
Ease of Use: "BTM is Easy to Delaminate"
Site 5
|
1.0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: At time of application of SSG (typically 28-35 days after application of BTM, Day 0)Population: Intention to treat
Operator ease of use as determined by physician survey, scored on a 1 to 5 scale, where 1 = strongly agree and 5 = strongly disagree. A higher score means a worse outcome.
Outcome measures
| Measure |
Biodegradable Temporizing Matrix (BTM)
n=33 Wounds treated with BTM
The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
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|---|---|
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Ease of Use: "BTM is a Product I Would Use for Other Burn Patients"
Site 5
|
1.0 score on a scale
Standard Deviation 0
|
|
Ease of Use: "BTM is a Product I Would Use for Other Burn Patients"
Site 1
|
2.0 score on a scale
Standard Deviation 0
|
|
Ease of Use: "BTM is a Product I Would Use for Other Burn Patients"
Site 3
|
1.0 score on a scale
Standard Deviation 0
|
|
Ease of Use: "BTM is a Product I Would Use for Other Burn Patients"
Site 4
|
1.3 score on a scale
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: 1, 2, 3, 6, 12 months after application of BTMPopulation: Intention to treat
Joint contracture after treatment, assessed by Joint Contracture Severity Scale. Joint Contracture Severity Scale is assessed per anatomical joint and assigned a value from 1 to 3, where 1 = Mild, 2 = Moderate, 3 = Severe. Results summarized as the number of participants who had at least one joint assessed with a joint contracture of each severity grade. Where more than one joint motion was affected (e.g. knee flexion, knee extension, etc.), the motion with the most severe contracture at a specific timepoint was reported in the summary results.
Outcome measures
| Measure |
Biodegradable Temporizing Matrix (BTM)
n=14 Participants
The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
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|---|---|
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Joint Contracture
1 month after SSG · 1, Mild
|
2 Participants
|
|
Joint Contracture
1 month after SSG · 2, Moderate
|
1 Participants
|
|
Joint Contracture
1 month after SSG · 3, Severe
|
1 Participants
|
|
Joint Contracture
2 months after SSG · 1, Mild
|
2 Participants
|
|
Joint Contracture
2 months after SSG · 2, Moderate
|
1 Participants
|
|
Joint Contracture
2 months after SSG · 3, Severe
|
1 Participants
|
|
Joint Contracture
3 months after SSG · 1, Mild
|
2 Participants
|
|
Joint Contracture
3 months after SSG · 2, Moderate
|
1 Participants
|
|
Joint Contracture
3 months after SSG · 3, Severe
|
0 Participants
|
|
Joint Contracture
6 months after SSG · 1, Mild
|
3 Participants
|
|
Joint Contracture
6 months after SSG · 2, Moderate
|
1 Participants
|
|
Joint Contracture
6 months after SSG · 3, Severe
|
0 Participants
|
|
Joint Contracture
12 months after SSG · 1, Mild
|
3 Participants
|
|
Joint Contracture
12 months after SSG · 2, Moderate
|
1 Participants
|
|
Joint Contracture
12 months after SSG · 3, Severe
|
0 Participants
|
SECONDARY outcome
Timeframe: 1, 2, 3, 6 and 12 months after application of SSGPopulation: Intention to treat
Scar appearance/quality assessed by the Modified Vancouver Scar Scale (mVSS), which includes 4 individual sub-scale scores of Pigmentation, Vascularity, Pliability, and Height (mm) of burn lesion and a Total of the individual sub-scale scores. Pigmentation: 0=Normal color, 1=Hypopigmentation, 2=Hyperpigmentation, 3=Combination/Mixed Vascularity: 0=Normal, 1=Pink, 2=Red, 3=Purple. Pliability: 0=Normal, 1=Supple, 2=Yielding, 3=Firm, 4=Banding, 5=Contracture. Height (mm): 0=Normal (flat), 1='\<2', 2='\>2 and \<5', 3='\>=5' Total: Sum of individual mVSS scores. Minimum total value = 0. Maximum total value = 14. Higher scores mean a worse outcome.
Outcome measures
| Measure |
Biodegradable Temporizing Matrix (BTM)
n=33 Wounds treated with BTM
The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
|
|---|---|
|
Scar Severity
1 month after SSG
|
7.3 Total score on a scale
Standard Deviation 2.7
|
|
Scar Severity
2 months after SSG
|
7.7 Total score on a scale
Standard Deviation 1.78
|
|
Scar Severity
3 months after SSG
|
6.7 Total score on a scale
Standard Deviation 1.61
|
|
Scar Severity
6 months after SSG
|
6.4 Total score on a scale
Standard Deviation 2.76
|
|
Scar Severity
12 months after SSG
|
4.5 Total score on a scale
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: At 1, 2, 3, 6, 12 months after application of SSGPopulation: Intention to treat
Pruritus incidence and severity assessed by Numerical Rating Scale from 0 to 10, where 0 = no itch and 10 = worst itch imaginable. Higher scores mean a worse outcome.
Outcome measures
| Measure |
Biodegradable Temporizing Matrix (BTM)
n=33 Wounds treated with BTM
The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
|
|---|---|
|
Skin Itch
1 month after SSG
|
2.8 score on a scale
Standard Deviation 4.05
|
|
Skin Itch
2 months after SSG
|
2.4 score on a scale
Standard Deviation 3.52
|
|
Skin Itch
3 months after SSG
|
3.3 score on a scale
Standard Deviation 3.35
|
|
Skin Itch
6 months after SSG
|
3.7 score on a scale
Standard Deviation 3.35
|
|
Skin Itch
12 months after SSG
|
4.4 score on a scale
Standard Deviation 4.18
|
Adverse Events
Biodegradable Temporizing Matrix
Serious events: 6 serious events
Other events: 14 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Biodegradable Temporizing Matrix
n=14 participants at risk
Biodegradable Temporizing Matrix (BTM)
Biodegradable Temporizing Matrix: The Biodegradable Temporizing Matrix (BTM) (also known as BTM Dressing) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
|
|---|---|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Injury, poisoning and procedural complications
Tracheostomy malfunction
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Fusarium infection
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Cellulitis infection right lower limb
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Vascular disorders
Arterial rupture
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Musculoskeletal and connective tissue disorders
Joint contracture on left shoulder
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
Other adverse events
| Measure |
Biodegradable Temporizing Matrix
n=14 participants at risk
Biodegradable Temporizing Matrix (BTM)
Biodegradable Temporizing Matrix: The Biodegradable Temporizing Matrix (BTM) (also known as BTM Dressing) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
|
|---|---|
|
Infections and infestations
Urinary tract infection pseudomonal
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Wound infection pseudomonas
|
14.3%
2/14 • Number of events 3 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Wound infection staphylococcal
|
14.3%
2/14 • Number of events 3 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Gastrointestinal disorders
Abdominal distention
|
21.4%
3/14 • Number of events 3 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Gastrointestinal disorders
Constipation
|
57.1%
8/14 • Number of events 8 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Gastrointestinal disorders
Diarrhoae
|
35.7%
5/14 • Number of events 6 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Gastrointestinal disorders
Ileus
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Gastrointestinal disorders
Intestinal dilatation
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Gastrointestinal disorders
Megacolon
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Gastrointestinal disorders
Nausea
|
57.1%
8/14 • Number of events 9 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Gastrointestinal disorders
Oral pain
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Gastrointestinal disorders
Peritoneal haematoma
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Gastrointestinal disorders
Vomiting
|
21.4%
3/14 • Number of events 3 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Abscess limb
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Aspergillus infection
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Candida infection
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Clostridium infection
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Device related infection
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Enterobacter infection
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Enterococcal infection
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Escherichia infection
|
21.4%
3/14 • Number of events 3 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Fungal skin infection
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Haemophilus infection
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Herpes simplex
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Herpes virus infection
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Klebsiella infection
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Oral candidiasis
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Pseudomonas infection
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Purulent discharge
|
14.3%
2/14 • Number of events 3 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Skin candida
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Staphylococcal infection
|
35.7%
5/14 • Number of events 11 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Subcutaneous abscess
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Systemic candida
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Tinea pedis
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Infections and infestations
Urinary tract infection fungal
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Skin and subcutaneous tissue disorders
Hypertrophic scar
|
21.4%
3/14 • Number of events 6 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
28.6%
4/14 • Number of events 5 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
28.6%
4/14 • Number of events 4 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Skin and subcutaneous tissue disorders
Skin hypertrophy
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer haemorrhage
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
General disorders
Application site haematoma
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
General disorders
Asthenia
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
General disorders
Chest pain
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
General disorders
Oedema peripheral
|
28.6%
4/14 • Number of events 4 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
General disorders
Pain
|
21.4%
3/14 • Number of events 3 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
General disorders
Physical deconditioning
|
21.4%
3/14 • Number of events 3 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
General disorders
Pyrexia
|
35.7%
5/14 • Number of events 5 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Psychiatric disorders
Acute stress disorder
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Psychiatric disorders
Agitation
|
28.6%
4/14 • Number of events 4 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Psychiatric disorders
Anxiety
|
28.6%
4/14 • Number of events 5 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Psychiatric disorders
Delirium
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Psychiatric disorders
Disorientation
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Psychiatric disorders
Hallucination
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Psychiatric disorders
Insomnia
|
50.0%
7/14 • Number of events 8 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Psychiatric disorders
Nightmare
|
28.6%
4/14 • Number of events 4 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Psychiatric disorders
Restlessness
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Injury, poisoning and procedural complications
Graft haemorrhage
|
7.1%
1/14 • Number of events 3 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Injury, poisoning and procedural complications
Incision site pruritus
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Injury, poisoning and procedural complications
Scar
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Injury, poisoning and procedural complications
Skin scar contracture
|
21.4%
3/14 • Number of events 4 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Injury, poisoning and procedural complications
Wound
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Vascular disorders
Arterial haemorrhage
|
7.1%
1/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Vascular disorders
Deep vein thrombosis
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Vascular disorders
Extremity necrosis
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Vascular disorders
Haematoma
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Vascular disorders
Hypertension
|
21.4%
3/14 • Number of events 3 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Vascular disorders
Hypotension
|
50.0%
7/14 • Number of events 10 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Vascular disorders
Pelvic vein thrombosis
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
7.1%
1/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Vascular disorders
Peripheral artery thrombosis
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Investigations
Aspergillus test positive
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Investigations
Blood calcium decreased
|
7.1%
1/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Investigations
Blood glucose decreased
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Investigations
Blood magnesium decreased
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Investigations
Blood phosphorus decreased
|
7.1%
1/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Investigations
Blood phosphorus increased
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Investigations
Blood potassium decreased
|
21.4%
3/14 • Number of events 9 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Investigations
Enterococcus test positive
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Investigations
Fungal test positive
|
14.3%
2/14 • Number of events 4 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Investigations
Haemoglobin decreased
|
7.1%
1/14 • Number of events 8 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Investigations
Herpes simplex test positive
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Investigations
Influenza virus test positive
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Investigations
International normalised ratio increased
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Investigations
Oxygen saturation decreased
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Investigations
Platelet count decreased
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Investigations
Pseudomonas test positive
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Investigations
Staphylococcus test positive
|
21.4%
3/14 • Number of events 4 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Investigations
Trichomonal test positive
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Investigations
Urine output decreased
|
21.4%
3/14 • Number of events 5 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Investigations
Weight decreased
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Metabolism and nutrition disorders
Acidosis
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
21.4%
3/14 • Number of events 3 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Blood and lymphatic system disorders
Anaemia
|
28.6%
4/14 • Number of events 5 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Musculoskeletal and connective tissue disorders
Extremity contracture
|
21.4%
3/14 • Number of events 6 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
28.6%
4/14 • Number of events 4 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Respiratory, thoracic and mediastinal disorders
Atelactasis
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.4%
3/14 • Number of events 3 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretions
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of upper respiratory secretion
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
28.6%
4/14 • Number of events 5 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
28.6%
4/14 • Number of events 4 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Cardiac disorders
Atrial flutter
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Cardiac disorders
Supraventricular tachycardia
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Cardiac disorders
Tachycardia
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Cardiac disorders
Ventricular extrasystoles
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Eye disorders
Dry eye
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Eye disorders
Eye movement disorder
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Eye disorders
Scleral oedema
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Nervous system disorders
Cognitive disorder
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Nervous system disorders
Neuralgia
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Nervous system disorders
Peroneal nerve palsy
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Renal and urinary disorders
Nephrolithiasis
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Renal and urinary disorders
Urinary retention
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Endocrine disorders
Cortisol deficiency
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60