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

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ClinicalTrials.gov Identifier: NCT02905435
Recruitment Status : Active, not recruiting
First Posted : September 19, 2016
Last Update Posted : August 7, 2018
Sponsor:
Collaborators:
PPD
Department of Health and Human Services
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Burns Device: Biodegradable Temporizing Matrix Not Applicable

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  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Experimental: Biodegradable Temporizing Matrix
Biodegradable Temporizing Matrix (BTM)
Device: Biodegradable Temporizing Matrix
The Biodegradable Temporizing Matrix (BTM) (also known as BTM Dressing) 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 Measures :
  1. BTM 'take' rate [ Time Frame: At time of application of SSG (typically 28-35 days after application of BTM, Day 0) ]
    %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.

  2. SSG 'take' rate over BTM [ Time Frame: 7-10 days after application of SSG ]
    Proportion of split skin graft (SSG) that 'takes' expressed as a percentage of SSG applied at 7-10 days after application of SSG

  3. Adverse Events [ Time Frame: All timepoints until 12 months after application of SSG ]
    Incidence and type of Adverse Events occurring after BTM implantation


Secondary Outcome Measures :
  1. Infection [ Time Frame: Day 0 (application of BTM), every 3-5 days until application of SSG and 1, 2, 3, 6 and 12 months ]
    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 [ Time Frame: 1, 2, 3, 6 and 12 months after application of SSG ]
    Clinical assessment of wound closure expressed as a percentage

  3. Ease of 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

  4. Joint contracture [ Time Frame: Day 0 (baseline), 1, 2, 3, 6 and 12 months after application of BTM ]
    Joint contracture after treatment compared with baseline, assessed by Joint Contracture Severity Scale and Range of Motion of joints

  5. 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

  6. Skin itch [ Time Frame: At SSG 'take' and 1, 2, 3, 6 and 12 months after application of SSG ]
    Pruritus incidence and severity assessed by Numerical Rating Scale



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905435


Locations
United States, Arizona
Arizona Burn Center at Maricopa Medical Center
Phoenix, Arizona, United States, 85008
United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95817
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
PolyNovo Biomaterials Pty Ltd.
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

Additional Information:
Responsible Party: PolyNovo Biomaterials Pty Ltd.
ClinicalTrials.gov Identifier: NCT02905435     History of Changes
Other Study ID Numbers: CP-002
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by PolyNovo Biomaterials Pty Ltd.:
burns
autografts
humans
biodegradable polyurethane
dermal matrix
synthetic

Additional relevant MeSH terms:
Burns
Wounds and Injuries