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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-05

Study Completion Date

2019-09-18

Brief Summary

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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).

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Detailed Description

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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

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Burns

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Biodegradable Temporizing Matrix

Biodegradable Temporizing Matrix (BTM)

Group Type EXPERIMENTAL

Biodegradable Temporizing Matrix

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No