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

Skin Graft Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05335720
• Other study ID #: DW_EGFCS
• Status: Completed
• Phase: N/A
• Start date: July 19, 2019
• Est. completion date: April 8, 2020

Study information

• Verified date: July 2022
• Source: PT. Daewoong Infion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 8, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Skin Graft Scar

Intervention

Drug:
• rhEGF
EASYEF® spray 50 mcg, sprayed twice a day for 14 days.

Locations

Country	Name	City	State
Indonesia	RSPAD Gatot Soebroto	Central Jakarta	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
PT. Daewoong Infion	Equilab International

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the wound healing time of each skin graft donor site	The definition of 'wound healing' is when there is no more exudate in the skin graft donor and the skin is covered with epithelial tissue in a milky light pink color and there is no pain. Healing time (morning or afternoon) evaluation and pain scale (11-point NRS (Numeric Rating Scale); 0 = No pain, 5 = Moderate pain, and 10 = Worst possible pain) will be assessed.	14 days
Secondary	Adverse Events	In order to confirm the adverse events (AE), it is confirmed through the questionnaire of investigators and the physical examination. If an adverse event occurs, record the timing of the adverse event, the duration, the extent of the adverse event, and the causal relationship.	14 days
Secondary	Photograph evaluation	During the change of dressing in the morning and evening, photograph was taken to evaluate the re-epithelization improvement.	14 days