Polynovo BTM Study

Full Name

Pivotal Study to Assess the Safety and Effectiveness of NovoSorb® Biodegradable Temporizing Matrix (BTM) in the Treatment of Severe Burn Skin Injuries

Description

This investigational study aims to test a new product known as BTM that replaces the dermal (middle) or deeper layer of skin. BTM is a foam made from polyurethane which is a synthetic material rather than animal or human skin. Treatment with BTM is applied during surgery. The total time in the investigational treatment protocol will be approximately 20 months for follow-up appointments, depending on the time it takes for the burn wounds to heal.

Participants will be assigned at random, by a computer program to one of two treatment groups: NovoSorb® BTM Group or Standard of Care Group

The standard of care treatment is the medical treatment that is normally provided to treat burn(s), if not participating in this clinical research study.

Purpose

To see if a new investigational device is safe and effective in the treatment of damaged skin, or skin that has been destroyed and the damage has entered the layer of fat beneath the skin.

Eligibility

Inclusion Criteria

Inclusion Criteria-including but may not be limited to:

Participants between 21 and 70 years of age, diagnosed with an injury due to deep burns (2nd degree deep and/or 3rd degree burns) caused by fire/flame, scalds or contact