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

Burns Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02905435
• Other study ID #: CP-002
• Status: Completed
• Phase: N/A
• Start date: November 5, 2016
• Est. completion date: September 18, 2019

Study information

• Verified date: May 2021
• Source: PolyNovo Biomaterials Pty Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 18, 2019
• Est. primary completion date: September 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• Biodegradable Temporizing Matrix
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.

Locations

Country	Name	City	State
United States	University of Tennessee Health Science Center	Memphis	Tennessee
United States	Arizona Burn Center at Maricopa Medical Center	Phoenix	Arizona
United States	University of California Davis Medical Center	Sacramento	California
United States	Tampa General Hospital	Tampa	Florida
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
PolyNovo Biomaterials Pty Ltd.	Biomedical Advanced Research and Development Authority, Department of Health and Human Services, PPD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	Adverse Events	Number and type of Adverse Events occurring after BTM implantation	All timepoints until 12 months after application of SSG
Secondary	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.	From day of application (Day 0) until 12 months after SSG.
Secondary	Wound Closure - Anterior Torso	Clinical assessment of wound closure expressed as a percentage, per anatomical region	1, 2, 3, 6, 12 months after application of SSG
Secondary	Wound Closure - Left Lower Limb	Clinical assessment of wound closure expressed as a percentage, per anatomical region	1, 2, 3, 6, 12 months after application of SSG
Secondary	Wound Closure - Left Upper Limb	Clinical assessment of wound closure expressed as a percentage, per anatomical region	1, 2, 3, 6, 12 months after application of SSG
Secondary	Wound Closure - Posterior Torso	Clinical assessment of wound closure expressed as a percentage, per anatomical region	1, 2, 3, 6, 12 months after application of SSG
Secondary	Wound Closure - Right Lower Limb	Clinical assessment of wound closure expressed as a percentage, per anatomical region	1, 2, 3, 6, 12 months after application of SSG
Secondary	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.	At time of application of SSG (typically 28-35 days after application of BTM, Day 0)
Secondary	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.	At time of application of SSG (typically 28-35 days after application of BTM, Day 0)
Secondary	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.	At time of application of SSG (typically 28-35 days after application of BTM, Day 0)
Secondary	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.	At time of application of SSG (typically 28-35 days after application of BTM, Day 0)
Secondary	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.	1, 2, 3, 6, 12 months after application of BTM
Secondary	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.	1, 2, 3, 6 and 12 months after application of SSG
Secondary	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.	At 1, 2, 3, 6, 12 months after application of SSG

External Links

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