The goal of this study to determine whether the combination biologic/drug DERMASEAL will safely decrease donor wound pain after split-thickness skin graft surgery. Participants will have their skin graft donor sites immediately treated with DERMASEAL versus standard of care wound dressings followed by periodic monitoring of their recovery.
This is a single center, single-blind, randomized, controlled phase 1/2 study of patients undergoing treatment of a cutaneous wound involving a split-thickness skin graft. A subject's study duration will be for up to a total of 16 weeks from randomization to end of study. This includes 1 week of treatment, followed by 3 weeks of Standard of Care plus a final follow-up visit 12 weeks after complete wound closure or the end of Standard of Care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
plasma film containing metallic silver microparticles and fibrin
adverse events
The safety of topically applying a plasma film containing metallic silver microparticles plus fibrin in patients with skin graft donor sites for 16 weeks following split-thickness skin grafting.
Time frame: 16 weeks
wound pain
The study will evaluate if using DERMASEAL is associated with a clinically meaningful difference in pain score (≥2 points on the Visual Analog Scale; minimal score =0 and maximal score = 10. A higher score means more pain) between the treatment and active control arms at any time during the 16-week study.
Time frame: 16 weeks
Percent wound healing
Percent of donor site wounds healed during the post-treatment weeks 1 through 4
Time frame: 4 weeks
Time to complete wound closure
Time to complete donor site wound closure during the post-treatment weeks 1 through 4
Time frame: 4 weeks
Recurrent donor site wound after complete wound closure
Recurrence of donor site after complete wound closure, requiring treatment, at any time during the 16-week study.
Time frame: 16 weeks
Scarring
Scarring as measured by the Vancouver Scar Scale at 16 weeks after surgery. The minimum value = 0 and maximal value = 13; higher scores mean a worse outcome.
Time frame: 16 weeks
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