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

NACompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

November 5, 2016

Primary Completion Date

September 6, 2018

Study Completion Date

September 18, 2019

Conditions
Burns
Interventions
DEVICE

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.

Trial Locations (5)

27157

Wake Forest University Health Sciences, Winston-Salem

33606

Tampa General Hospital, Tampa

38163

University of Tennessee Health Science Center, Memphis

85008

Arizona Burn Center at Maricopa Medical Center, Phoenix

95817

University of California Davis Medical Center, Sacramento

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PPD Development, LP

INDUSTRY

collaborator

Department of Health and Human Services

FED

collaborator

Biomedical Advanced Research and Development Authority

FED

lead

PolyNovo Biomaterials Pty Ltd.

INDUSTRY

NCT02905435 - Assessment of Safety and Effectiveness of Biodegradable Temporizing Matrix in the Treatment of Deep Burn Skin Injuries | Biotech Hunter | Biotech Hunter