At a glance
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A Phase I/II Study to Evaluate the Safety and Efficacy of TWB-103 in Adult Patients With Split-Thickness Skin Graft Donor Site Wounds (DSW)
In Brief
A Phase 2 clinical trial evaluating TWB-103 Group and Placebo Group for Donor Site Complication. Completed, enrolled 48 participants across 3 sites in 2 countries.
Detailed Summary
Primary objective: 1. To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW) for Phase I in terms of Incidence of treatment-related AEs and SAEs (including infections and bleeding) 2. To evaluate the efficacy for Phase I+II of TWB-103 in split-thickness skin graft donor site wounds (DSW) in terms of The healing time from DSW creation to 100% re-epithelialization Secondary objective: 1. To evaluate the efficacy of TWB-103 in split-thickness skin graft donor site wounds (DSW) in secondary efficacy endpoints 2. To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW) in secondary safety endpoints
Study Details
Timeline
Interventions
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.