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.
Hobart W. Harris
Lead sponsor
Vitruvian Medical Devices, Inc.
Sponsor institution
Vitruvian Medical Devices, Inc.
Collaborator