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.
Men or women ≥ 21 years of age.
The subject is able and willing to adhere to study procedures and informed consent is obtained.
Patient scheduled to undergo a split-thickness skin graft > 25 cm2 and ≤ 300 cm2 with a wound depth of between 0.010 - 0.015 inch (0.2 - 0.4 mm).
Target donor site wound involving the torso or upper or lower extremities.
Hypersensitivity to silver or fresh frozen plasma.
Active infection or history of radiation to the donor site.
Insensate at the donor site.
Elevated INR>3.0.
Parallel
DERMASEAL
Combination productplasma 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.
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.
Percent wound healing
Percent of donor site wounds healed during the post-treatment weeks 1 through 4
Time to complete wound closure
Time to complete donor site wound closure during the post-treatment weeks 1 through 4
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.
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.
Click on the lead sponsor to view all of their trials.
Hobart W. Harris
Lead sponsor
Vitruvian Medical Devices, Inc.
Sponsor institution
Vitruvian Medical Devices, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
