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

NCT02905435 | Completed Results DMC

• 1 other identifier: CP-002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

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).

Conditions

Burns

Keywords

burns; autografts; humans; biodegradable polyurethane; dermal matrix; synthetic

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• Infection

  From day of application (Day 0) until 12 months after SSG.

• Wound Closure - Anterior Torso

  1, 2, 3, 6, 12 months after application of SSG

• Wound Closure - Left Lower Limb

  1, 2, 3, 6, 12 months after application of SSG

• Wound Closure - Left Upper Limb

  1, 2, 3, 6, 12 months after application of SSG

• Wound Closure - Posterior Torso

  1, 2, 3, 6, 12 months after application of SSG

Study Arms (1)

Biodegradable Temporizing Matrix

EXPERIMENTAL

Biodegradable Temporizing Matrix (BTM)

Device: Biodegradable Temporizing Matrix

Interventions

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.

Biodegradable Temporizing Matrix

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• PolyNovo Biomaterials Pty Ltd.: lead
• PPD Development, LP: collaborator
• Department of Health and Human Services: collaborator
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (5)

Arizona Burn Center at Maricopa Medical Center

Phoenix, Arizona, 85008, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

Related Links

• Sponsor website

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Tim Barker, PhD
• Organization: PolyNovo Biomaterials Pty Ltd

tim.b@polynovo.com

+61386814054

Study Officials

• Marcus JD Wagstaff, MBBS, PhD

  Royal Adelaide Hospital, Adelaide SA 5000, AUSTRALIA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 19, 2016
• Study Start: November 5, 2016
• Primary Completion: September 6, 2018
• Study Completion: September 18, 2019
• Last Updated: June 8, 2021
• Results First Posted: June 8, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)