Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00157131 | Safety and Efficacy Study of FS 4 IU VH S/D (Fibrin Sealant With 4IU/mL Thrombin, Vapor Heated, Solvent/Detergent Treated) to Adhere Split Thickness Skin Grafts and Improve Wound Healing in Burn Patients | PHASE3 | COMPLETED | 150 | — | — | Jun 1, 2004 | Feb 1, 2007 | Apr 20, 2017 | 17 | United States |
| 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...