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The primary objective of this study is to evaluate skin graft adherence and wound healing in burn patients to evaluate whether FS 4IU VH S/D is equivalent or superior to the current standard of care (staples). The primary endpoint is achievement of complete (100%) wound closure within 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete wound closure by Day 28 after treatment with either FS 4IU VH S/D or staples as determined by a blinded independent review of the Day 28 photographs | 28 days after treatment | |
| Adverse experiences (AEs) deemed possibly or probably related to treatment with FS 4IU VH S/D | 12 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of hematoma/seroma on Day 1 | 1 day after treatment | |
| Percent area of hematoma/seroma on Day 1 | 1 day after treatment | |
| 100% engraftment by Day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Greenhalgh, MD | Shriners Hospitals for Children, Northern Calif. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18354285 | Result | Foster K, Greenhalgh D, Gamelli RL, Mozingo D, Gibran N, Neumeister M, Abrams SZ, Hantak E, Grubbs L, Ploder B, Schofield N, Riina LH; FS 4IU VH S/D Clinical Study Group. Efficacy and safety of a fibrin sealant for adherence of autologous skin grafts to burn wounds: results of a phase 3 clinical study. J Burn Care Res. 2008 Mar-Apr;29(2):293-303. doi: 10.1097/BCR.0b013e31816673f8. |
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|
| Staples | Other | Administration by mechanical/multiple point fixation. |
|
| 5 days after treatment |
| Percent area of engraftment on Day 5 | 5 days after treatment |
| Complete wound closure by Day 14 | 14 days after treatment |
| Percent area of closure by Days 14 and 28 | 14 and 28 days after treatment |
| Scar maturation assessed by blinded Vancouver Scar Scale evaluations on Months 3, 6, 9, and 12 | 3, 6, 9, and 12 months after treatment |
| Mobile |
| Alabama |
| United States |
| Phoenix | Arizona | United States |
| Orange | California | United States |
| Sacramento | California | United States |
| San Diego | California | United States |
| Gainesville | Florida | United States |
| Maywood | Illinois | United States |
| Springfield | Illinois | United States |
| Baltimore | Maryland | United States |
| Lincoln | Nebraska | United States |
| Cincinnati | Ohio | United States |
| Allentown | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Lubbock | Texas | United States |
| Seattle | Washington | United States |
| Madison | Wisconsin | United States |
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| D013537 | Sutures |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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