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

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

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).

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Device: Biodegradable Temporizing Matrix

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Arizona Burn Center at Maricopa Medical Center
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • University of Tennessee Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Biodegradable Temporizing Matrix; Biodegradable Temporizing Matrix (BTM)

Device: Biodegradable 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: PolyNovo Biomaterials Pty Ltd.
• Collaborators: PPD; Department of Health and Human Services; Biomedical Advanced Research and Development Authority
• Investigators: Principal Investigator: Marcus JD Wagstaff, MBBS, PhD, Royal Adelaide Hospital, Adelaide SA 5000, AUSTRALIA

Publications and helpful links

Helpful Links

• Sponsor website

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2016
• Primary Completion (Actual): September 6, 2018
• Study Completion (Actual): September 18, 2019

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 19, 2016

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: burns; humans; autografts; biodegradable polyurethane; dermal matrix; synthetic
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: CP-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No