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

NCT ID: NCT05335720

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-19
• Study Completion Date: 2020-04-08

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

1. EASYEF® + moist gauze EASYEF® is applied directly on the wound surface then moist dressing is used as primary dressing before covered with dry gauze. All dressings are fixed with elastic bandage.

2. Tulle gauze + moist gauze Tulle gauze is applied directly on the wound surface then moist dressing is used as primary dressing before covered with dry gauze. All dressings are fixed with elastic bandage.

Group Type: ACTIVE_COMPARATOR

rhEGF

Intervention Type: DRUG

EASYEF® spray 50 mcg, sprayed twice a day for 14 days.

Cohort 2

1. EASYEF® + tulle gauze + moist gauze EASYEF® is applied directly on the wound surface then tulle gauze and moist gauze is used as primary dressing before covered with dry gauze. All dressings are fixed with elastic bandage.

2. Tulle gauze + moist gauze Tulle gauze is applied directly on the wound surface then moist dressing is used as primary dressing before covered with dry gauze. All dressings are fixed with elastic bandage.

Group Type: ACTIVE_COMPARATOR

rhEGF

Intervention Type: DRUG

EASYEF® spray 50 mcg, sprayed twice a day for 14 days.

Interventions

rhEGF

EASYEF® spray 50 mcg, sprayed twice a day for 14 days.

Intervention Type: DRUG

Other Intervention Names

EASYEF®

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Equilab International

UNKNOWN

Sponsor Role: collaborator

PT. Daewoong Infion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

RSPAD Gatot Soebroto

Central Jakarta, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

DW_EGFCS

Identifier Type: -

Identifier Source: org_study_id