PNV Media Thread, page-25

Thanks Getready, it was well worth the listen, I reckon things will start to move quickly in the near future, keep in mind that this use of BTM will not be the biggest earner but it will definitely help people who are badly burnt, my heart goes out to them, but without BTM I believe most of the people who have 70% or more burns to their body would die in the past, what just happened in Adelaide is just a miracle IMHO?

This trial will help -: https://clinicaltrials.gov/ct2/show/NCT02905435

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

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1		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.

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1	ClinicalTrials.gov Identifier: NCT02905435
2	Recruitment Status : Active, not recruitingFirst Posted : September 19, 2016Last Update Posted : April 9, 2019

Sponsor:
PolyNovo Biomaterials Pty Ltd.
Collaborators:
PPD
Department of Health and Human Services
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
PolyNovo Biomaterials Pty Ltd.

• Study Details

Study Description

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).

	Condition or disease	Intervention/treatment	Phase
1	Burns	Device: Biodegradable Temporizing Matrix	Not Applicable

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mce-anchorDetailed 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.
mce-anchorStudy Design

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	Study Type :	Interventional (Clinical Trial)
1	Actual Enrollment :	15 participants
2	Intervention Model:	Single Group Assignment
3	Masking:	None (Open Label)
4	Primary Purpose:	Treatment
5	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.
6	Actual Study Start Date :	November 5, 2016
7	Actual Primary Completion Date :	September 6, 2018
8	Estimated Study Completion Date :	December 2019

Resource links provided by the National Library of Medicine

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MedlinePlus related topics: Burns
U.S. FDA Resources
mce-anchorArms and Interventions

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	Arm	Intervention/treatment
1	Experimental: Biodegradable Temporizing MatrixBiodegradable Temporizing Matrix (BTM)	Device: Biodegradable Temporizing MatrixThe 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.

mce-anchorOutcome Measures

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Primary Outcome Measures :

1. 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.
2. 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
3. Adverse Events [ Time Frame: All timepoints until 12 months after application of SSG ]
   Incidence and type of Adverse Events occurring after BTM implantation

Secondary Outcome Measures :

1. 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.
2. Wound closure [ Time Frame: 1, 2, 3, 6 and 12 months after application of SSG ]
   Clinical assessment of wound closure expressed as a percentage
3. 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
4. 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
5. 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
6. 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

mce-anchorEligibility Criteria

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Information from the National Library of Medicine

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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

	Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
1	Sexes Eligible for Study:	All
2	Accepts Healthy Volunteers:	No

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.