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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02905435
Recruitment Status : Completed
First Posted : September 19, 2016
Last Update Posted : May 8, 2020
Sponsor:
Collaborators:
PPD
Department of Health and Human Services
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
PolyNovo Biomaterials Pty Ltd.

Tracking Information
First Submitted Date  ICMJE September 8, 2016
First Posted Date  ICMJE September 19, 2016
Last Update Posted Date May 8, 2020
Actual Study Start Date  ICMJE November 5, 2016
Actual Primary Completion Date September 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2016)
  • 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.
  • 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
  • Adverse Events [ Time Frame: All timepoints until 12 months after application of SSG ]
    Incidence and type of Adverse Events occurring after BTM implantation
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2016)
  • 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.
  • Wound closure [ Time Frame: 1, 2, 3, 6 and 12 months after application of SSG ]
    Clinical assessment of wound closure expressed as a percentage
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Safety and Effectiveness of Biodegradable Temporizing Matrix in the Treatment of Deep Burn Skin Injuries
Official Title  ICMJE A Traditional Feasibility Study to Assess the Safety and Effectiveness of the Biodegradable Temporizing Matrix (BTM) in the Treatment of Deep Burn Skin Injuries.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Burns
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Biodegradable Temporizing Matrix
Biodegradable Temporizing Matrix (BTM)
Intervention: Device: Biodegradable Temporizing Matrix
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2018)
15
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 18, 2019
Actual Primary Completion Date September 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02905435
Other Study ID Numbers  ICMJE CP-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party PolyNovo Biomaterials Pty Ltd.
Study Sponsor  ICMJE PolyNovo Biomaterials Pty Ltd.
Collaborators  ICMJE
  • PPD
  • Department of Health and Human Services
  • Biomedical Advanced Research and Development Authority
Investigators  ICMJE
Principal Investigator: Marcus JD Wagstaff, MBBS, PhD Royal Adelaide Hospital, Adelaide SA 5000, AUSTRALIA
PRS Account PolyNovo Biomaterials Pty Ltd.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP