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Sheet skin grafts affixed with Fibrin Sealant with/mL Thrombin · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin | DRUG | - |
Inclusion Criteria: * Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to screening activities * Male or female age \>= 6 and \<= 65 years of age * Total burn wounds measuring \<= 40% TBSA to include a deep partial thickness/full thi...
It is used to fix sheet skin grafts onto burn wounds and to support wound healing. The product combines a fibrin sealant with 4 IU/mL thrombin to hold the graft in place. It is being studied in patients with burn wounds, including pediatric patients as young as 6 years old.
Baxter International Inc. (ticker BAX) is the developer of this fibrin sealant product for skin graft fixation in burn wounds. Baxter is the company named as the sponsor of the clinical program evaluating the product.
It is in Phase 1 clinical development. The product is investigational and has been evaluated in a single Phase 1 trial, which is now completed. No active trials are currently listed for this product.
The product has been studied in one completed Phase 1 trial, NCT00161759, titled Safety and Efficacy Study of Fibrin Sealant (FS 4IU) for Skin Graft Fixation and Wound Healing in Subjects With Burn Wounds. The trial enrolled 40 participants in the United States and was randomized.