Clinical trial NCT02905435: Assessment of Safety and Effectiveness of Biodegradable Temporizing Matrix in the Treatment of Deep Burn Skin Injuries
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: burns
autografts
humans
biodegradable polyurethane
dermal matrix
synthetic
Lead sponsor: PolyNovo Biomaterials Pty Ltd.
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
name: Department of Health and Human Services
name: Biomedical Advanced Research and Development Authority
First posted: 2016-09-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: BTM 'Take' Rate
timeFrame: At time of application of split skin graft (SSG) (typically 28-35 days after application of BTM, Day 0)
measure: SSG 'Take' Rate Over BTM
timeFrame: 7-10 days after application of SSG
measure: Adverse Events
timeFrame: All timepoints until 12 months after application of SSG
Secondary outcomes:
measure: Infection
timeFrame: From day of application (Day 0) until 12 months after SSG.
measure: Wound Closure - Anterior Torso
timeFrame: 1, 2, 3, 6, 12 months after application of SSG
measure: Wound Closure - Left Lower Limb
timeFrame: 1, 2, 3, 6, 12 months after application of SSG
measure: Wound Closure - Left Upper Limb
timeFrame: 1, 2, 3, 6, 12 months after application of SSG
measure: Wound Closure - Posterior Torso
timeFrame: 1, 2, 3, 6, 12 months after application of SSG
measure: Wound Closure - Right Lower Limb
timeFrame: 1, 2, 3, 6, 12 months after application of SSG
measure: Ease of Use: "BTM is Easy to Use"
timeFrame: At time of application of SSG (typically 28-35 days after application of BTM, Day 0)
measure: Ease of Use: "BTM is Easy to Apply"
timeFrame: At time of application of SSG (typically 28-35 days after application of BTM, Day 0)
measure: Ease of Use: "BTM is Easy to Delaminate"
timeFrame: At time of application of SSG (typically 28-35 days after application of BTM, Day 0)
measure: Ease of Use: "BTM is a Product I Would Use for Other Burn Patients"
timeFrame: At time of application of SSG (typically 28-35 days after application of BTM, Day 0)
measure: Joint Contracture
timeFrame: 1, 2, 3, 6, 12 months after application of BTM
measure: Scar Severity
timeFrame: 1, 2, 3, 6 and 12 months after application of SSG
measure: Skin Itch
timeFrame: At 1, 2, 3, 6, 12 months after application of SSG
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Burn Center at Maricopa Medical Center
state: Arizona
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
Study officials:
affiliation: Royal Adelaide Hospital, Adelaide SA 5000, AUSTRALIA
name: Marcus JD Wagstaff, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: