Assessment of Safety and Effectiveness of Biodegradable Temporizing Matrix in the Treatment of Deep Burn Skin Injuries

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Traditional Feasibility Study to Assess the Safety and Effectiveness of the Biodegradable Temporizing Matrix (BTM) in the Treatment of Deep Burn Skin Injuries.

Conditions
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Burns

Intervention / Treatment
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* Device: Biodegradable Temporizing Matrix


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biodegradable Temporizing Matrix<br>Biodegradable Temporizing Matrix (BTM) | Device: Biodegradable Temporizing Matrix<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At time of application of split skin graft (SSG) (typically 28-35 days after application of BTM, Day 0) | 
| 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. | 7-10 days after application of SSG | 
| Adverse Events | Number and type of Adverse Events occurring after BTM implantation | All timepoints until 12 months after application of SSG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From day of application (Day 0) until 12 months after SSG. | 
| Wound Closure - Anterior Torso | Clinical assessment of wound closure expressed as a percentage, per anatomical region | 1, 2, 3, 6, 12 months after application of SSG | 
| Wound Closure - Left Lower Limb | Clinical assessment of wound closure expressed as a percentage, per anatomical region | 1, 2, 3, 6, 12 months after application of SSG | 
| Wound Closure - Left Upper Limb | Clinical assessment of wound closure expressed as a percentage, per anatomical region | 1, 2, 3, 6, 12 months after application of SSG | 
| Wound Closure - Posterior Torso | Clinical assessment of wound closure expressed as a percentage, per anatomical region | 1, 2, 3, 6, 12 months after application of SSG | 
| Wound Closure - Right Lower Limb | Clinical assessment of wound closure expressed as a percentage, per anatomical region | 1, 2, 3, 6, 12 months after application of SSG | 
| 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. | At time of application of SSG (typically 28-35 days after application of BTM, Day 0) | 
| 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. | At time of application of SSG (typically 28-35 days after application of BTM, Day 0) | 
| 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. | At time of application of SSG (typically 28-35 days after application of BTM, Day 0) | 
| 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. | At time of application of SSG (typically 28-35 days after application of BTM, Day 0) | 
| 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. | 1, 2, 3, 6, 12 months after application of BTM | 
| 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. | 1, 2, 3, 6 and 12 months after application of SSG | 
| 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. | At 1, 2, 3, 6, 12 months after application of SSG | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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burns, autografts, humans, biodegradable polyurethane, dermal matrix, synthetic