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

PolyNovo Biomaterials Pty Ltd.15 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Burns

Interventions

Biodegradable Temporizing MatrixDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (5)

Arizona Burn Center at Maricopa Medical Center

Phoenix, Arizona, United States

University of California Davis Medical Center

Sacramento, California, United States

Tampa General Hospital

Tampa, Florida, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

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)

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

Adverse Events

Number and type of Adverse Events occurring after BTM implantation

Time frame: All timepoints until 12 months after application of SSG

Secondary Outcomes

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.

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

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

Data from ClinicalTrials.gov

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University of Tennessee Health Science Center

Memphis, Tennessee, United States

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

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

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

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)

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)

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)

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)

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

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

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