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Study to Assess the Safety and Efficacy of DERMASEAL for the Treatment of Split-Thickness Skin Graft Donor Site Wounds

Skin Graft Complications Clinical Trial

Official title:
A Single-Blind, Randomized, Controlled, Single Center Clinical Study to Assess the Safety and Efficacy of DERMASEAL Advanced Wound Care Dressing for the Treatment of Split-Thickness Skin Graft Donor Site Wounds

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06134843
Study type Interventional
Source Vitruvian Medical Devices, Inc.
Contact David M Young, MD
Phone (415) 347-5332
Email dyoungucsfplastics@gmail.com
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date September 1, 2024
Completion date April 15, 2025
View Details
See also
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