NCT05335720

Efficacy and Safety Evaluation of EASYEF® in Acute Wound (Split-thickness Skin Graft Donor Site)

Study to Evaluate the Efficacy and Safety of EASYEF® in Acute Wound (Split-thickness Skin Graft Donor Site)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: PT. Daewoong Infion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is a prospective study, randomized, using control, open-label, single-center to evaluate the efficacy and safety of EASYEF® in acute wound (split-thickness skin graft donor site). A total of 10 subjects are randomly allocated. Subjects who meet the final inclusion and exclusion criteria are randomized to the test cohorts in a ratio of 1:1:1.

Detailed description

This study was intended to determine the effect of EGF on acute wounds such as trauma, surgical wounds and burns. But in this study, skin graft donor site wounds were used because they were the most representative for acute wounds and the depth and extent of the wounds could be controlled. EGF is known pharmacologically to accelerate epithelial cell proliferation, fibroblast cells and endothelial cells. Giving EGF in acute wounds is expected to accelerate wound healing and improve patient quality of life.

Conditions

• Skin Graft Scar
• Split-Thickness Skin Graft (STSG)

Interventions

Type	Name	Description
DRUG	rhEGF	EASYEF® spray 50 mcg, sprayed twice a day for 14 days.

Timeline

• Start date: 2019-07-19
• Primary completion: 2020-03-01
• Completion: 2020-04-08
• First posted: 2022-04-19
• Last updated: 2022-07-22

Locations

1 site across 1 country: Indonesia