Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fibrin Sealant, ARTISS/ml VH SD · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| FS 4IU VH S/D | EXPERIMENTAL | FS 4IU VH S/D was administered intraoperatively to the wound bed by spray application using the TISSOMAT and Spray Set. Only the DUPLOJECTvii system and Spray Set (connection tube with sterile filter and spray head) device was used for simultaneous spray application of the study product. A thin layer of FS 4IU VH S/D was applied to the wound bed using a "painting motion" from side to side to achieve coverage. The recommended dosing volume was 2.0 to 4.0 mL/100 cm2. One 2-mL pack (4 mL total volume) of FS 4IU VH S/D applied using the TISSOMAT and Spray Set was sufficient to coat a wound bed of 100-200 cm2. |
| Staples | ACTIVE_COMPARATOR | Staples are the current standard of care in burn surgery and are well accepted as the control in this type of study. |
| Name | Type | Description |
|---|---|---|
| Fibrin Sealant, ARTISS 4IU/ml VH SD | BIOLOGICAL | FS 4IU VH S/D, a two-component fibrin sealant with 4 IU/mL human thrombin, vapor heated, solvent detergent treated, provided in a frozen, ready-to-use formulation. Administration by a topical spray application using the TISSOMAT device and Spray Set. |
| Staples | OTHER | Administration by mechanical/multiple point fixation. |
Inclusion Criteria: * Subjects or their legal representatives, who have read, understood and signed a written informed consent. * Subjects of either sex. * Female subjects of childbearing potential with a negative urine or serum pregnancy test on admission. * Subjects who are \<= 65 years of age in...
Fibrin Sealant is used for esophageal and/or gastric varices and deep partial or full thickness wounds. In clinical trials, it has been studied for adhering split thickness skin grafts and improving wound healing in burn patients, as well as for endoscopic injection to treat bleeding esophageal varices.
Fibrin Sealant is developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker BAX.
Fibrin Sealant is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA based on the available information. Two Phase 3 trials have been completed.
Fibrin Sealant has been studied in two completed Phase 3 trials. NCT00157131 evaluated its safety and efficacy in adhering split thickness skin grafts in burn patients with deep partial or full thickness wounds. NCT00161915 compared endoscopic injection of fibrin sealant versus endoscopic ligature for bleeding esophageal varices.
Fibrin Sealant is a small molecule therapeutic. It works by mimicking the final step of the blood coagulation cascade, forming a fibrin clot that adheres to tissues and promotes hemostasis and wound healing. This mechanism is relevant for its use in variceal bleeding and wound closure.