Clinical trial NCT05335720: Efficacy and Safety Evaluation of EASYEF® in Acute Wound (Split-thickness Skin Graft Donor Site)
Official title: Study to Evaluate the Efficacy and Safety of EASYEF® in Acute Wound (Split-thickness Skin Graft Donor Site)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Graft Scar
Split-Thickness Skin Graft (STSG)
Keywords: EGF
Epidermal Growth Factor
rhEGF
recombinant human Epidermal Growth Factor
Acute wound
Skin graft
Lead sponsor: PT. Daewoong Infion
Sponsor class: INDUSTRY
Collaborators: name: Equilab International
First posted: 2022-04-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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 contraception and who do not consent to continue contraception for the duration of the trial.

Primary outcomes:
measure: Comparison of the wound healing time of each skin graft donor site
timeFrame: 14 days
Secondary outcomes:
measure: Adverse Events
timeFrame: 14 days
measure: Photograph evaluation
timeFrame: 14 days
Other outcomes:
Locations:
city: Central Jakarta
country: Indonesia
facility: RSPAD Gatot Soebroto
state: DKI Jakarta
Study officials:
References: