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Completed

NCT Number: NCT02905435

Assessment of Safety and Effectiveness of Biodegradable Temporizing Matrix 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).

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Key information

Conditions

Burns Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Burn Center at Maricopa Medical Center, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biodegradable Temporizing Matrix

Device

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 outcomes

  1. BTM 'Take' Rate

    Time frame: 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.

  2. SSG 'Take' Rate Over BTM

    Time frame: 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.

  3. Adverse Events

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

    Number and type of Adverse Events occurring after BTM implantation

Secondary outcomes

  1. Infection

    Time frame: 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.

  2. Wound Closure - Anterior Torso

    Time frame: 1, 2, 3, 6, 12 months after application of SSG

    Clinical assessment of wound closure expressed as a percentage, per anatomical region

  3. Wound Closure - Left Lower Limb

    Time frame: 1, 2, 3, 6, 12 months after application of SSG

    Clinical assessment of wound closure expressed as a percentage, per anatomical region

  4. Wound Closure - Left Upper Limb

    Time frame: 1, 2, 3, 6, 12 months after application of SSG

    Clinical assessment of wound closure expressed as a percentage, per anatomical region

  5. Wound Closure - Posterior Torso

    Time frame: 1, 2, 3, 6, 12 months after application of SSG

    Clinical assessment of wound closure expressed as a percentage, per anatomical region

  6. Wound Closure - Right Lower Limb

    Time frame: 1, 2, 3, 6, 12 months after application of SSG

    Clinical assessment of wound closure expressed as a percentage, per anatomical region

  7. Ease of Use: "BTM is Easy to Use"

    Time frame: 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.

  8. Ease of Use: "BTM is Easy to Apply"

    Time frame: 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.

  9. Ease of Use: "BTM is Easy to Delaminate"

    Time frame: 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.

  10. Ease of Use: "BTM is a Product I Would Use for Other Burn Patients"

    Time frame: 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.

  11. Joint Contracture

    Time frame: 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.

  12. Scar Severity

    Time frame: 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.

  13. Skin Itch

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

PolyNovo Biomaterials Pty Ltd.

Industry

Collaborators

  • Biomedical Advanced Research and Development Authority
  • Department of Health and Human Services
  • PPD Development, LP

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Sep 19, 2016
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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