Efficacy and Safety Evaluation of EASYEF® in Acute Wound (Split-thickness Skin Graft Donor Site) (NCT05335720) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety Evaluation of EASYEF® in Acute Wound (Split-thickness Skin Graft Donor Site)
Indonesia10 participantsStarted 2019-07-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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…
What they're measuring
1
Comparison of the wound healing time of each skin graft donor site