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

Not Applicable

Completed

Conditions: Burns

Interventions: Device: Biodegradable Temporizing Matrix

Registration Number: NCT02905435

Lead Sponsor: PolyNovo Biomaterials Pty Ltd.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 15

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biodegradable Temporizing Matrix	Biodegradable Temporizing Matrix	Biodegradable Temporizing Matrix (BTM)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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.
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.
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
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.
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.
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.
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.
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
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.
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.

Trial Locations

Locations (5): Arizona Burn Center at Maricopa Medical Center
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Phoenix, Arizona, United States
University of California Davis Medical Center
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Sacramento, California, United States
Tampa General Hospital
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Tampa, Florida, United States
University of Tennessee Health Science Center
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Memphis, Tennessee, United States
Wake Forest University Health Sciences
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Winston-Salem, North Carolina, United States