CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Biodegradable Temporizing Matrixdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02905435
NCT02905435N/ACompleted
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A Traditional Feasibility Study to Assess the Safety and Effectiveness of the Biodegradable Temporizing Matrix (BTM) in the Treatment of Deep Burn Skin Injuries.

PolyNovo Biomaterials Pty Ltd.·interventional·Posted Sep 19, 2016·Updated Jun 8, 2021

In Brief

A clinical study evaluating Biodegradable Temporizing Matrix for Burns. Completed, enrolled 15 participants across 5 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBurns
CountriesUnited States
CollaboratorsPPD Development, LP, Department of Health and Human Services, Biomedical Advanced Research and Development Authority

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 19, 2016
Enrollment StartNov 5, 2016
Primary CompletionSep 6, 2018
Study CompletionSep 18, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.8 years ago

Interventions

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.