Burns
Conditions
Keywords
burns, autografts, humans, biodegradable polyurethane, dermal matrix, synthetic
Brief summary
This is a multi-center, single arm, traditional feasibility study to allow a preliminary assessment of the safety and effectiveness of a new method of treating skin burns using Biodegradable Temporizing Matrix (BTM).
Detailed description
This is a multi-center, single arm, traditional feasibility study to allow a preliminary assessment of the safety and effectiveness of BTM treatment. Patients with 10-70% TBSA burns will have BTM devices implanted in areas with deep partial or full thickness burns to treat at least 5% TBSA.
Interventions
DEVICEBiodegradable Temporizing Matrix
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.
Sponsors
PPD Development, LP
Department of Health and Human Services
Biomedical Advanced Research and Development Authority
PolyNovo Biomaterials Pty Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Provides written informed consent (directly or via legal representative) prior to any clinical trial procedures being performed. * Willing to comply with all study procedures and expects to be available for the duration of the study. * Male and non-pregnant females ≥ 18 years of age and ≤ 70 years of age. * Patients with deep partial or full thickness burns (between 10% and 70% inclusive of their TBSA).
Exclusion criteria
* Has a known hypersensitivity to polyurethane or silver-containing materials. * Multiple traumas (significant traumatic injury to a solid organ in addition to skin). * Presence of a medical condition with a life expectancy of less than 12 months, such as advanced malignancy. * Presence of a medical condition that might interfere with treatment evaluation; or require a change in therapy including but not limited to, significant immune deficiency, or skin or vascular diseases in the area of the wound. * Female with known or suspected pregnancy, planned pregnancy, or lactation. * Has had exposure to any other investigational agent within the last 6 months. * Has a clinically significant psychiatric illness. * Has a condition the Investigator believes would interfere with the ability to comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BTM 'Take' Rate | At time of application of split skin graft (SSG) (typically 28-35 days after application of BTM, Day 0) | 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. |
| SSG 'Take' Rate Over BTM | 7-10 days after application of SSG | 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. |
| Adverse Events | All timepoints until 12 months after application of SSG | Number and type of Adverse Events occurring after BTM implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Closure - Left Upper Limb | 1, 2, 3, 6, 12 months after application of SSG | Clinical assessment of wound closure expressed as a percentage, per anatomical region |
| Wound Closure - Posterior Torso | 1, 2, 3, 6, 12 months after application of SSG | Clinical assessment of wound closure expressed as a percentage, per anatomical region |
| Wound Closure - Right Lower Limb | 1, 2, 3, 6, 12 months after application of SSG | Clinical assessment of wound closure expressed as a percentage, per anatomical region |
| Ease of Use: BTM is Easy to Use | At time of application of SSG (typically 28-35 days after application of BTM, Day 0) | 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. |
| Ease of Use: BTM is Easy to Apply | At time of application of SSG (typically 28-35 days after application of BTM, Day 0) | 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. |
| Infection | 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. |
| Ease of Use: BTM is a Product I Would Use for Other Burn Patients | At time of application of SSG (typically 28-35 days after application of BTM, Day 0) | 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. |
| Joint Contracture | 1, 2, 3, 6, 12 months after application of BTM | 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. |
| Scar Severity | 1, 2, 3, 6 and 12 months after application of SSG | 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. |
| Skin Itch | At 1, 2, 3, 6, 12 months after application of SSG | 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. |
| Ease of Use: BTM is Easy to Delaminate | At time of application of SSG (typically 28-35 days after application of BTM, Day 0) | 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. |
| Wound Closure - Anterior Torso | 1, 2, 3, 6, 12 months after application of SSG | Clinical assessment of wound closure expressed as a percentage, per anatomical region |
| Wound Closure - Left Lower Limb | 1, 2, 3, 6, 12 months after application of SSG | Clinical assessment of wound closure expressed as a percentage, per anatomical region |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Biodegradable Temporizing Matrix |
|---|---|
| Age, Continuous | 43.7 years STANDARD_DEVIATION 15.23 |
| Body Mass Index (BMI) | 30.8 kilograms/metre^2 STANDARD_DEVIATION 8.3 |
| Burn Etiology Other (Contact) | 1 Participants |
| Burn Etiology Thermal | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick Skin Type Type I | 0 Participants |
| Fitzpatrick Skin Type Type II | 2 Participants |
| Fitzpatrick Skin Type Type III | 7 Participants |
| Fitzpatrick Skin Type Type IV | 1 Participants |
| Fitzpatrick Skin Type Type V | 1 Participants |
| Fitzpatrick Skin Type Unknown | 3 Participants |
| Height | 174.1 centimetres STANDARD_DEVIATION 10.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 9 Participants |
| % Total Body Surface Area (TBSA) affected by deep dermal/full thickness burn injury | 45.1 Percentage of total body surface area |
| Weight | 93.0 kilograms STANDARD_DEVIATION 26.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 14 |
| other Total, other adverse events | 14 / 14 |
| serious Total, serious adverse events | 6 / 14 |
Outcome results
Primary
Adverse Events
Number and type of Adverse Events occurring after BTM implantation
Time frame: All timepoints until 12 months after application of SSG
Population: Intention to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Biodegradable Temporizing Matrix (BTM) | Adverse Events | Any adverse event | 340 adverse events |
| Biodegradable Temporizing Matrix (BTM) | Adverse Events | Any adverse event leading to treatment discontinuation | 3 adverse events |
| Biodegradable Temporizing Matrix (BTM) | Adverse Events | Any NCI CTCAE Grade 3 or higher adverse event | 8 adverse events |
| Biodegradable Temporizing Matrix (BTM) | Adverse Events | Any device-related adverse event | 3 adverse events |
| Biodegradable Temporizing Matrix (BTM) | Adverse Events | Any serious adverse event (SAE) | 6 adverse events |
| Biodegradable Temporizing Matrix (BTM) | Adverse Events | Any adverse event leading to death | 2 adverse events |
| Biodegradable Temporizing Matrix (BTM) | Adverse Events | Any unanticipated adverse device effect (UADE) adverse event | 0 adverse events |
Primary
BTM 'Take' Rate
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.
Time frame: At time of application of split skin graft (SSG) (typically 28-35 days after application of BTM, Day 0)
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biodegradable Temporizing Matrix (BTM) | BTM 'Take' Rate | 95.22 percentage of BTM take per subject | Standard Deviation 7.175 |
Primary
SSG 'Take' Rate Over BTM
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.
Time frame: 7-10 days after application of SSG
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biodegradable Temporizing Matrix (BTM) | SSG 'Take' Rate Over BTM | 97.53 percentage of SSG take per subject | Standard Deviation 7.501 |
Secondary
Ease of Use: BTM is a Product I Would Use for Other Burn Patients
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.
Time frame: At time of application of SSG (typically 28-35 days after application of BTM, Day 0)
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biodegradable Temporizing Matrix (BTM) | 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 |
| Biodegradable Temporizing Matrix (BTM) | 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 |
| Biodegradable Temporizing Matrix (BTM) | Ease of Use: BTM is a Product I Would Use for Other Burn Patients | Site 4 | 1.3 score on a scale | Standard Deviation 0.6 |
| Biodegradable Temporizing Matrix (BTM) | 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 |
Secondary
Ease of Use: BTM is Easy to Apply
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.
Time frame: At time of application of SSG (typically 28-35 days after application of BTM, Day 0)
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biodegradable Temporizing Matrix (BTM) | Ease of Use: BTM is Easy to Apply | Site 1 | 2.0 score on a scale | Standard Deviation 0 |
| Biodegradable Temporizing Matrix (BTM) | Ease of Use: BTM is Easy to Apply | Site 3 | 1.0 score on a scale | Standard Deviation 0 |
| Biodegradable Temporizing Matrix (BTM) | Ease of Use: BTM is Easy to Apply | Site 4 | 1.8 score on a scale | Standard Deviation 0.94 |
| Biodegradable Temporizing Matrix (BTM) | Ease of Use: BTM is Easy to Apply | Site 5 | 1.0 score on a scale | Standard Deviation 0 |
Secondary
Ease of Use: BTM is Easy to Delaminate
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.
Time frame: At time of application of SSG (typically 28-35 days after application of BTM, Day 0)
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biodegradable Temporizing Matrix (BTM) | Ease of Use: BTM is Easy to Delaminate | Site 1 | 1.0 score on a scale | Standard Deviation 0 |
| Biodegradable Temporizing Matrix (BTM) | Ease of Use: BTM is Easy to Delaminate | Site 3 | 1.0 score on a scale | Standard Deviation 0 |
| Biodegradable Temporizing Matrix (BTM) | Ease of Use: BTM is Easy to Delaminate | Site 4 | 1.2 score on a scale | Standard Deviation 0.4 |
| Biodegradable Temporizing Matrix (BTM) | Ease of Use: BTM is Easy to Delaminate | Site 5 | 1.0 score on a scale | Standard Deviation 0 |
Secondary
Ease of Use: BTM is Easy to Use
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.
Time frame: At time of application of SSG (typically 28-35 days after application of BTM, Day 0)
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biodegradable Temporizing Matrix (BTM) | Ease of Use: BTM is Easy to Use | Site 5 | 1.0 score on a scale | Standard Deviation 0 |
| Biodegradable Temporizing Matrix (BTM) | Ease of Use: BTM is Easy to Use | Site 1 | 2.0 score on a scale | Standard Deviation 0 |
| Biodegradable Temporizing Matrix (BTM) | Ease of Use: BTM is Easy to Use | Site 3 | 1.0 score on a scale | Standard Deviation 0 |
| Biodegradable Temporizing Matrix (BTM) | Ease of Use: BTM is Easy to Use | Site 4 | 1.7 score on a scale | Standard Deviation 0.69 |
Secondary
Infection
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.
Time frame: From day of application (Day 0) until 12 months after SSG.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Biodegradable Temporizing Matrix (BTM) | Infection | Not infected | 21 Wounds treated with BTM |
| Biodegradable Temporizing Matrix (BTM) | Infection | Infected | 12 Wounds treated with BTM |
| Biodegradable Temporizing Matrix (BTM) | Infection | Infected - study device retained | 7 Wounds treated with BTM |
| Biodegradable Temporizing Matrix (BTM) | Infection | Infected - study device partially removed | 2 Wounds treated with BTM |
| Biodegradable Temporizing Matrix (BTM) | Infection | Infected - study device totally removed | 3 Wounds treated with BTM |
Secondary
Joint Contracture
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.
Time frame: 1, 2, 3, 6, 12 months after application of BTM
Population: Intention to treat
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Biodegradable Temporizing Matrix (BTM) | Joint Contracture | 1 month after SSG | 1, Mild | 2 Participants |
| Biodegradable Temporizing Matrix (BTM) | Joint Contracture | 1 month after SSG | 2, Moderate | 1 Participants |
| Biodegradable Temporizing Matrix (BTM) | Joint Contracture | 1 month after SSG | 3, Severe | 1 Participants |
| Biodegradable Temporizing Matrix (BTM) | Joint Contracture | 2 months after SSG | 1, Mild | 2 Participants |
| Biodegradable Temporizing Matrix (BTM) | Joint Contracture | 2 months after SSG | 2, Moderate | 1 Participants |
| Biodegradable Temporizing Matrix (BTM) | Joint Contracture | 2 months after SSG | 3, Severe | 1 Participants |
| Biodegradable Temporizing Matrix (BTM) | Joint Contracture | 3 months after SSG | 1, Mild | 2 Participants |
| Biodegradable Temporizing Matrix (BTM) | Joint Contracture | 3 months after SSG | 2, Moderate | 1 Participants |
| Biodegradable Temporizing Matrix (BTM) | Joint Contracture | 3 months after SSG | 3, Severe | 0 Participants |
| Biodegradable Temporizing Matrix (BTM) | Joint Contracture | 6 months after SSG | 1, Mild | 3 Participants |
| Biodegradable Temporizing Matrix (BTM) | Joint Contracture | 6 months after SSG | 2, Moderate | 1 Participants |
| Biodegradable Temporizing Matrix (BTM) | Joint Contracture | 6 months after SSG | 3, Severe | 0 Participants |
| Biodegradable Temporizing Matrix (BTM) | Joint Contracture | 12 months after SSG | 1, Mild | 3 Participants |
| Biodegradable Temporizing Matrix (BTM) | Joint Contracture | 12 months after SSG | 2, Moderate | 1 Participants |
| Biodegradable Temporizing Matrix (BTM) | Joint Contracture | 12 months after SSG | 3, Severe | 0 Participants |
Secondary
Scar Severity
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.
Time frame: 1, 2, 3, 6 and 12 months after application of SSG
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biodegradable Temporizing Matrix (BTM) | Scar Severity | 1 month after SSG | 7.3 Total score on a scale | Standard Deviation 2.7 |
| Biodegradable Temporizing Matrix (BTM) | Scar Severity | 2 months after SSG | 7.7 Total score on a scale | Standard Deviation 1.78 |
| Biodegradable Temporizing Matrix (BTM) | Scar Severity | 3 months after SSG | 6.7 Total score on a scale | Standard Deviation 1.61 |
| Biodegradable Temporizing Matrix (BTM) | Scar Severity | 6 months after SSG | 6.4 Total score on a scale | Standard Deviation 2.76 |
| Biodegradable Temporizing Matrix (BTM) | Scar Severity | 12 months after SSG | 4.5 Total score on a scale | Standard Deviation 2.24 |
Secondary
Skin Itch
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.
Time frame: At 1, 2, 3, 6, 12 months after application of SSG
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biodegradable Temporizing Matrix (BTM) | Skin Itch | 1 month after SSG | 2.8 score on a scale | Standard Deviation 4.05 |
| Biodegradable Temporizing Matrix (BTM) | Skin Itch | 2 months after SSG | 2.4 score on a scale | Standard Deviation 3.52 |
| Biodegradable Temporizing Matrix (BTM) | Skin Itch | 3 months after SSG | 3.3 score on a scale | Standard Deviation 3.35 |
| Biodegradable Temporizing Matrix (BTM) | Skin Itch | 6 months after SSG | 3.7 score on a scale | Standard Deviation 3.35 |
| Biodegradable Temporizing Matrix (BTM) | Skin Itch | 12 months after SSG | 4.4 score on a scale | Standard Deviation 4.18 |
Secondary
Wound Closure - Anterior Torso
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Time frame: 1, 2, 3, 6, 12 months after application of SSG
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Anterior Torso | 1 month after SSG | 99.8 % wound closure | Standard Deviation 0.45 |
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Anterior Torso | 2 months after SSG | 99.8 % wound closure | Standard Deviation 0.5 |
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Anterior Torso | 3 months after SSG | 99.8 % wound closure | Standard Deviation 0.5 |
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Anterior Torso | 6 months after SSG | 100.0 % wound closure | Standard Deviation 0 |
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Anterior Torso | 12 months after SSG | 100 % wound closure | Standard Deviation 0 |
Secondary
Wound Closure - Left Lower Limb
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Time frame: 1, 2, 3, 6, 12 months after application of SSG
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Left Lower Limb | 1 month after SSG | 95.8 % wound closure | Standard Deviation 4.27 |
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Left Lower Limb | 2 months after SSG | 95.8 % wound closure | Standard Deviation 4.27 |
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Left Lower Limb | 3 months after SSG | 100 % wound closure | Standard Deviation 0 |
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Left Lower Limb | 6 months after SSG | 100 % wound closure | Standard Deviation 0 |
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Left Lower Limb | 12 months after SSG | 100 % wound closure | Standard Deviation 0 |
Secondary
Wound Closure - Left Upper Limb
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Time frame: 1, 2, 3, 6, 12 months after application of SSG
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Left Upper Limb | 1 month after SSG | 100.0 % wound closure | Standard Deviation 0 |
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Left Upper Limb | 2 months after SSG | 100.0 % wound closure | Standard Deviation 0 |
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Left Upper Limb | 3 months after SSG | 100.0 % wound closure | Standard Deviation 0 |
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Left Upper Limb | 6 months after SSG | 100.0 % wound closure | Standard Deviation 0 |
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Left Upper Limb | 12 months after SSG | 100.0 % wound closure | Standard Deviation 0 |
Secondary
Wound Closure - Posterior Torso
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Time frame: 1, 2, 3, 6, 12 months after application of SSG
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Posterior Torso | 1 month after SSG | 94.8 % wound closure | Standard Deviation 9.84 |
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Posterior Torso | 2 months after SSG | 95.8 % wound closure | Standard Deviation 8.84 |
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Posterior Torso | 3 months after SSG | 100.0 % wound closure | Standard Deviation 0 |
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Posterior Torso | 6 months after SSG | 100.0 % wound closure | Standard Deviation 0 |
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Posterior Torso | 12 months after SSG | 99.6 % wound closure | Standard Deviation 0.89 |
Secondary
Wound Closure - Right Lower Limb
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Time frame: 1, 2, 3, 6, 12 months after application of SSG
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Right Lower Limb | 1 month after SSG | 96.0 % wound closure | Standard Deviation 4.52 |
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Right Lower Limb | 2 months after SSG | 96.3 % wound closure | Standard Deviation 4.79 |
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Right Lower Limb | 3 months after SSG | 99.8 % wound closure | Standard Deviation 0.45 |
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Right Lower Limb | 6 months after SSG | 99.8 % wound closure | Standard Deviation 0.5 |
| Biodegradable Temporizing Matrix (BTM) | Wound Closure - Right Lower Limb | 12 months after SSG | 99.7 % wound closure | Standard Deviation 0.58 |