BurnsNCT02905435

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

A study testing Biodegradable Temporizing Matrix in people with Burns, run by PolyNovo Biomaterials Pty Ltd. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Burns
What is being tested?: Biodegradable Temporizing Matrix
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 5 sitesUnited States
Study dates: 5 Nov 2016to 18 Sep 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

University of Tennessee Health Science Center
Memphis, Tennessee, 38163
Arizona Burn Center at Maricopa Medical Center
Phoenix, Arizona, 85008
University of California Davis Medical Center
Sacramento, California, 95817
Tampa General Hospital
Tampa, Florida, 33606
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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.

Read the 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.

Conditions: Burns
Being tested: Biodegradable Temporizing Matrix
Keywords: burns, autografts, humans, biodegradable polyurethane, dermal matrix, synthetic
Medical subject headings: Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Biodegradable Temporizing MatrixDevice
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.

Study groups in NCT02905435
Study group	Role	What they receive
Biodegradable Temporizing Matrix	Experimental	Biodegradable Temporizing Matrix (BTM) Receives: Device: Biodegradable Temporizing Matrix

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 7-10 days after application of SSG
Adverse Events
Number and type of Adverse Events occurring after BTM implantation
Measured: All timepoints until 12 months after application of SSG

Secondary outcomes (13)

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.
Measured: From day of application (Day 0) until 12 months after SSG.
Wound Closure - Anterior Torso
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Measured: 1, 2, 3, 6, 12 months after application of SSG
Wound Closure - Left Lower Limb
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Measured: 1, 2, 3, 6, 12 months after application of SSG
Wound Closure - Left Upper Limb
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Measured: 1, 2, 3, 6, 12 months after application of SSG
Wound Closure - Posterior Torso
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Measured: 1, 2, 3, 6, 12 months after application of SSG
Wound Closure - Right Lower Limb
Clinical assessment of wound closure expressed as a percentage, per anatomical region
Measured: 1, 2, 3, 6, 12 months after application of SSG
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.
Measured: At time of application of SSG (typically 28-35 days after application of BTM, Day 0)
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.
Measured: At time of application of SSG (typically 28-35 days after application of BTM, Day 0)
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.
Measured: At time of application of SSG (typically 28-35 days after application of BTM, Day 0)
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.
Measured: At time of application of SSG (typically 28-35 days after application of BTM, Day 0)
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.
Measured: 1, 2, 3, 6, 12 months after application of BTM
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.
Measured: 1, 2, 3, 6 and 12 months after application of SSG
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.
Measured: At 1, 2, 3, 6, 12 months after application of SSG

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 201618 Sep 2019

First posted19 Sep 2016 (estimated)
Study start5 Nov 2016
Primary completion6 Sep 2018
Study completion18 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for BurnsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02905435
Sponsor's protocol ID: CP-002
Status last verified: May 2021
First submitted: 8 Sep 2016
Last updated: 8 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Burns trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT02905435
Acronym / sponsor ID: CP-002
Conditions: Burns
Keywords: burns, autografts, humans, biodegradable polyurethane, dermal matrix, synthetic
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: PolyNovo Biomaterials Pty Ltd.Industry (pharma, biotech, devices)
Collaborators: PPD Development, LP, Department of Health and Human Services, Biomedical Advanced Research and Development Authority
Study start: 5 Nov 2016 (actual)
Primary completion: 6 Sep 2018 (actual)
Study completion: 18 Sep 2019 (actual)
First posted: 19 Sep 2016 (estimated)
Results: Posted 8 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Biodegradable Temporizing Matrix	Experimental	Device: Biodegradable Temporizing MatrixBiodegradable Temporizing Matrix (BTM)

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Biodegradable Temporizing MatrixThe 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.	Device	Biodegradable Temporizing Matrix

Primary outcome

BTM 'Take' Rate
Time frame: At time of application of split skin graft (SSG) (typically 28-35 days after application of BTM, Day 0)
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.
SSG 'Take' Rate Over BTM
Time frame: 7-10 days after application of SSG
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.
Adverse Events
Time frame: All timepoints until 12 months after application of SSG
Number and type of Adverse Events occurring after BTM implantation

13 secondary outcomes

Infection
Time frame: From day of application (Day 0) until 12 months after SSG.
Wound Closure - Anterior Torso
Time frame: 1, 2, 3, 6, 12 months after application of SSG
Wound Closure - Left Lower Limb
Time frame: 1, 2, 3, 6, 12 months after application of SSG
Wound Closure - Left Upper Limb
Time frame: 1, 2, 3, 6, 12 months after application of SSG
Wound Closure - Posterior Torso
Time frame: 1, 2, 3, 6, 12 months after application of SSG
Wound Closure - Right Lower Limb
Time frame: 1, 2, 3, 6, 12 months after application of SSG
Ease of Use: "BTM is Easy to Use"
Time frame: At time of application of SSG (typically 28-35 days after application of BTM, Day 0)
Ease of Use: "BTM is Easy to Apply"
Time frame: At time of application of SSG (typically 28-35 days after application of BTM, Day 0)
Ease of Use: "BTM is Easy to Delaminate"
Time frame: At time of application of SSG (typically 28-35 days after application of BTM, Day 0)
Ease of Use: "BTM is a Product I Would Use for Other Burn Patients"
Time frame: At time of application of SSG (typically 28-35 days after application of BTM, Day 0)
Joint Contracture
Time frame: 1, 2, 3, 6, 12 months after application of BTM
Scar Severity
Time frame: 1, 2, 3, 6 and 12 months after application of SSG
Skin Itch
Time frame: At 1, 2, 3, 6, 12 months after application of SSG

Results and safety

Results posted to the registry on 8 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Biodegradable Temporizing Matrix	14	7

Primary outcome: BTM 'Take' Rate

Time frame: At time of application of split skin graft (SSG) (typically 28-35 days after application of BTM, Day 0). Mean (Standard Deviation). Unit: percentage of BTM take per subject

Measure	Biodegradable Temporizing Matrix (BTM) n = 12
Value	95.22 (7.175)

Population analysed: Intention to treat

Primary outcome: SSG 'Take' Rate Over BTM

Time frame: 7-10 days after application of SSG. Mean (Standard Deviation). Unit: percentage of SSG take per subject

Measure	Biodegradable Temporizing Matrix (BTM) n = 11
Value	97.53 (7.501)

Population analysed: Intention to treat

Primary outcome: Adverse Events

Time frame: All timepoints until 12 months after application of SSG. Number. Unit: adverse events

Measure	Biodegradable Temporizing Matrix (BTM) n = 14
Any adverse event	340
Any adverse event leading to treatment discontinuation	3
Any NCI CTCAE Grade 3 or higher adverse event	8
Any device-related adverse event	3
Any serious adverse event (SAE)	6
Any adverse event leading to death	2
Any unanticipated adverse device effect (UADE) adverse event	0

Population analysed: Intention to treat

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected over the study period of up to 12 months after application of the split-thickness skin graft.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Biodegradable Temporizing Matrix	6 of 14 (42.9%)	14 of 14 (100%)	2 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Sponsor websiteLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marcus JD Wagstaff, MBBS, PhD principal investigator

Royal Adelaide Hospital, Adelaide SA 5000, AUSTRALIA

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Biodegradable Temporizing Matrix in people with Burns, run by PolyNovo Biomaterials Pty Ltd. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BTM 'Take' Rate (time frame: At time of application of split skin graft (SSG) (typically 28-35 days after application of BTM, Day 0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02905435.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.