Deep Partial or Full Thickness Wounds Clinical Trial
Official title:
A Study To Evaluate the Safety and Efficacy of Fibrin Sealant With 4IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS 4IU VH S/D) to Adhere Tissues and Improve Wound Healing
| Verified date | April 2017 |
| Source | Baxter Healthcare Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | February 2007 |
| Est. primary completion date | February 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 65 Years |
| Eligibility |
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 including pediatric subjects of all ages. - Subjects with total burn wounds measuring <= 40% TBSA. - Subjects with a contiguous deep partial thickness/full thickness wound, between 2% and 8% TBSA or two comparable, bilateral wounds each measuring between 1% and 4% TBSA. - Wounds designated as test sites require autologous sheet skin grafts with a thickness of 8/1000" - 16/1000" - Subjects who are able, and willing to comply with the procedures required by the protocol. Exclusion Criteria: - Subjects with electrical burns. - Subjects with chemical burns - Digits and genitalia are excluded as test sites. - Subjects with infection at test area/test sites. - Subjects with test sites previously randomized and treated in this study. - Subjects with venous or arterial vascular disorder that directly affects a designated test area/test site. - Subjects with pre-existing hemolytic anemia - Subjects with diabetes mellitus. - Subjects with documented history of pathologically or pharmacologically induced immune deficiency. - Subjects judged to be chronically malnourished. - Subjects that are judged to have significant pulmonary compromise. - Subjects receiving systemic corticosteroids within 30 days prior to skin grafting (not including inhaled steroids). - Subjects with known or suspected hypersensitivity to bovine proteins. - Subjects participating in another clinical trial that is evaluating an unapproved drug or device. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Baxter Healthcare Corporation |
United States,
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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | ||
| Primary | Adverse experiences (AEs) deemed possibly or probably related to treatment with FS 4IU VH S/D | 12 months after treatment | ||
| Secondary | Presence of hematoma/seroma on Day 1 | 1 day after treatment | ||
| Secondary | Percent area of hematoma/seroma on Day 1 | 1 day after treatment | ||
| Secondary | 100% engraftment by Day 5 | 5 days after treatment | ||
| Secondary | Percent area of engraftment on Day 5 | 5 days after treatment | ||
| Secondary | Complete wound closure by Day 14 | 14 days after treatment | ||
| Secondary | Percent area of closure by Days 14 and 28 | 14 and 28 days after treatment | ||
| Secondary | Scar maturation assessed by blinded Vancouver Scar Scale evaluations on Months 3, 6, 9, and 12 | 3, 6, 9, and 12 months after treatment |