NCT06134843

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Hobart W. Harris · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Skin Graft Complications

Interventions

Type	Name	Description
COMBINATION_PRODUCT	DERMASEAL	plasma film containing metallic silver microparticles and fibrin

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-01-31
• Completion: 2025-04-15
• First posted: 2023-11-18
• Last updated: 2024-06-11

Regulatory

• FDA-regulated drug study