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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
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.
Administration by mechanical/multiple point fixation.
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Phoenix, Arizona, United States
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
Time frame: 28 days after treatment
Adverse experiences (AEs) deemed possibly or probably related to treatment with FS 4IU VH S/D
Time frame: 12 months after treatment
Presence of hematoma/seroma on Day 1
Time frame: 1 day after treatment
Percent area of hematoma/seroma on Day 1
Time frame: 1 day after treatment
100% engraftment by Day 5
Time frame: 5 days after treatment
Percent area of engraftment on Day 5
Time frame: 5 days after treatment
Complete wound closure by Day 14
Time frame: 14 days after treatment
Percent area of closure by Days 14 and 28
Time frame: 14 and 28 days after treatment
Scar maturation assessed by blinded Vancouver Scar Scale evaluations on Months 3, 6, 9, and 12
Time frame: 3, 6, 9, and 12 months after treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Orange, California, United States
Unnamed facility
Sacramento, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Gainesville, Florida, United States
Unnamed facility
Maywood, Illinois, United States
Unnamed facility
Springfield, Illinois, United States
Unnamed facility
Baltimore, Maryland, United States
...and 7 more locations