Deep Partial or Full Thickness Wounds
Conditions
Keywords
autologous sheet skin grafts, FS 4IU VH S/D, skin grafts, burn
Brief summary
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.
Interventions
BIOLOGICALFibrin Sealant, ARTISS 4IU/ml VH SD
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.
OTHERStaples
Administration by mechanical/multiple point fixation.
Sponsors
Baxter Healthcare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 100% engraftment by Day 5 | 5 days after treatment |
| Percent area of engraftment on Day 5 | 5 days after treatment |
| Presence of hematoma/seroma on Day 1 | 1 day 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 |
| Complete wound closure by Day 14 | 14 days after treatment |
| Percent area of hematoma/seroma on Day 1 | 1 day after treatment |
Countries
United States
Outcome results
None listed