NCT02905435

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: PolyNovo Biomaterials Pty Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-11-05
• Primary completion: 2018-09-06
• Completion: 2019-09-18
• First posted: 2016-09-19
• Last updated: 2021-06-08
• Results posted: 2021-06-08

Locations

5 sites across 1 country: United States