Status:
COMPLETED
Efficacy and Safety Evaluation of EASYEF® in Acute Wound (Split-thickness Skin Graft Donor Site)
Lead Sponsor:
PT. Daewoong Infion
Collaborating Sponsors:
Equilab International
Conditions:
Skin Graft Scar
Split-Thickness Skin Graft (STSG)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 o...
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 r...
Eligibility Criteria
Inclusion
- Patients who have donor wounds on the vertical (upper and lower) lines of the thigh through skin grafted surgery due to trauma, ulcers, burns, and incisional surgical defects.
- The size of the donor follows the standard and the distance between the two skin transplants is at least 2 cm.
- Patients who are expected to be able to successfully complete or benefit from this examination are based on appropriate medical assessment.
- Patients is willing to be treated 7 days as inpatient and treated as outpatient for maximum 7 days with homecare nurse visit.
- Patients is willing to stay near the hospital and visit the hospital after the donor site wound is declared healed by doctor.
- Patients who decided and agreed in writing to enroll in this study at their own will.
- Patients aged 18 and up
Exclusion
- Patients with different skin donor site can influence the results of the study.
- Patients who have other diseases that can interfere with wound healing such as immunosuppressive, metabolic collagen, peripheral vascular obstructive disease (PAOD), systemic vasculitis, and others.
- Patients have the talent for keloid formation.
- Patients have uncontrolled diabetes and diabetes with complications.
- Patients with liver disease, kidney disease, and other serious diseases that can affect this study.
- Patients who are deemed difficult to carry out the study by the investigators.
- Women who are pregnant, lactation or not using reliable methods of contraception and who do not consent to continue contraception for the duration of the trial.
Key Trial Info
Start Date :
July 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05335720
Start Date
July 19 2019
End Date
April 8 2020
Last Update
July 22 2022
Active Locations (1)
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1
RSPAD Gatot Soebroto
Central Jakarta, DKI Jakarta, Indonesia, 10410