Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARTISS human fibrin sealant · 1 trial · 1 indication
Measured at Day 1, 7, 30, 180 0 None- No apparent edema 1. Mild- Minimal tissue swelling 2. Moderate- Moderate edema, nasal features still discernible 3. Severe- Marked swelling, difficulty distinguishing nasal features Scores closer to 0 indicate more favorable results
Safety will be assessed by the incidence of AEs throughout the study period as documented by clinician observations at study visits and in a 30-day subject diary.
| Arm | Type | Description |
|---|---|---|
| ARTISS Human Fibrin Sealant | EXPERIMENTAL | Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes. |
| Standard of Care | NO_INTERVENTION | Fixation of the skin flap created during external rhinoplasty will use the standard of care |
| Name | Type | Description |
|---|---|---|
| ARTISS human fibrin sealant | BIOLOGICAL | - |
Inclusion Criteria: 1. Males and females between 18 and 65 years of age. 2. Subjects requesting primary rhinoplasty and requiring an external approach. 3. Subjects willing to undergo treatment with fibrin sealant. 4. Willingness and ability to comply with protocol requirements, including returning ...
ARTISS human fibrin sealant is used in subjects requesting and requiring an open rhinoplasty. It is a fibrin sealant applied during the surgical procedure to help with tissue adhesion. The product is being studied for its efficacy and safety in this specific surgical context.
ARTISS human fibrin sealant is developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker BAX. Baxter is the sponsor of the clinical trial evaluating this product for use in open rhinoplasty procedures.
ARTISS human fibrin sealant is in Phase 2 clinical development. The product is investigational and has not been approved for the studied indication. A Phase 2 trial has been completed to evaluate its efficacy and safety in external rhinoplasty.
ARTISS human fibrin sealant has one completed Phase 2 clinical trial registered as NCT01684020. The study, titled "A Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty," enrolled 10 participants in the United States and was completed.
ARTISS human fibrin sealant is a specific formulation of human fibrin sealant developed by Baxter. It is being studied for use in open rhinoplasty, a surgical procedure. The product is distinct in its application and is currently under clinical investigation for this indication.