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

Primary Purpose

Burns

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biodegradable Temporizing Matrix
Sponsored by
PolyNovo Biomaterials Pty Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring burns, autografts, humans, biodegradable polyurethane, dermal matrix, synthetic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Burn Center at Maricopa Medical Center
  • University of California Davis Medical Center
  • Tampa General Hospital
  • Wake Forest University Health Sciences
  • University of Tennessee Health Science Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biodegradable Temporizing Matrix

Arm Description

Biodegradable Temporizing Matrix (BTM)

Outcomes

Primary Outcome Measures

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.
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.
Adverse Events
Number and type of Adverse Events occurring after BTM implantation

Secondary Outcome Measures

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.
Wound Closure - Anterior Torso
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Wound Closure - Left Lower Limb
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Wound Closure - Left Upper Limb
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Wound Closure - Posterior Torso
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Wound Closure - Right Lower Limb
Clinical assessment of wound closure expressed as a percentage, per anatomical region
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 8, 2016
Last Updated
May 12, 2021
Sponsor
PolyNovo Biomaterials Pty Ltd.
Collaborators
PPD, Department of Health and Human Services, Biomedical Advanced Research and Development Authority
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1. Study Identification

Unique Protocol Identification Number
NCT02905435
Brief Title
Assessment of Safety and Effectiveness of Biodegradable Temporizing Matrix in the Treatment of Deep Burn Skin Injuries
Official Title
A Traditional Feasibility Study to Assess the Safety and Effectiveness of the Biodegradable Temporizing Matrix (BTM) in the Treatment of Deep Burn Skin Injuries.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 5, 2016 (Actual)
Primary Completion Date
September 6, 2018 (Actual)
Study Completion Date
September 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PolyNovo Biomaterials Pty Ltd.
Collaborators
PPD, Department of Health and Human Services, Biomedical Advanced Research and Development Authority

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
burns, autografts, humans, biodegradable polyurethane, dermal matrix, synthetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biodegradable Temporizing Matrix
Arm Type
Experimental
Arm Description
Biodegradable Temporizing Matrix (BTM)
Intervention Type
Device
Intervention Name(s)
Biodegradable Temporizing Matrix
Intervention Description
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.
Primary Outcome Measure Information:
Title
BTM 'Take' Rate
Description
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)
Title
SSG 'Take' Rate Over BTM
Description
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
Title
Adverse Events
Description
Number and type of Adverse Events occurring after BTM implantation
Time Frame
All timepoints until 12 months after application of SSG
Secondary Outcome Measure Information:
Title
Infection
Description
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.
Title
Wound Closure - Anterior Torso
Description
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Time Frame
1, 2, 3, 6, 12 months after application of SSG
Title
Wound Closure - Left Lower Limb
Description
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Time Frame
1, 2, 3, 6, 12 months after application of SSG
Title
Wound Closure - Left Upper Limb
Description
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Time Frame
1, 2, 3, 6, 12 months after application of SSG
Title
Wound Closure - Posterior Torso
Description
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Time Frame
1, 2, 3, 6, 12 months after application of SSG
Title
Wound Closure - Right Lower Limb
Description
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Time Frame
1, 2, 3, 6, 12 months after application of SSG
Title
Ease of Use: "BTM is Easy to Use"
Description
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)
Title
Ease of Use: "BTM is Easy to Apply"
Description
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)
Title
Ease of Use: "BTM is Easy to Delaminate"
Description
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)
Title
Ease of Use: "BTM is a Product I Would Use for Other Burn Patients"
Description
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)
Title
Joint Contracture
Description
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
Title
Scar Severity
Description
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
Title
Skin Itch
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus JD Wagstaff, MBBS, PhD
Organizational Affiliation
Royal Adelaide Hospital, Adelaide SA 5000, AUSTRALIA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Burn Center at Maricopa Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://polynovo.com/
Description
Sponsor website

Learn more about this trial

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

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