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

NCT05335720 | Completed

• 1 other identifier: DW_EGFCS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

EGF; Epidermal Growth Factor; rhEGF; recombinant human Epidermal Growth Factor; Acute wound; Skin graft

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adverse Events

  14 days

• Photograph evaluation

  14 days

Study Arms (2)

Cohort 1

ACTIVE COMPARATOR

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.

Drug: rhEGF

Cohort 2

ACTIVE COMPARATOR

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.

Drug: rhEGF

Interventions

rhEGF DRUG

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

Also known as: EASYEF®

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PT. Daewoong Infion: lead
• Equilab International: collaborator

Study Sites (1)

RSPAD Gatot Soebroto

Central Jakarta, DKI Jakarta, 10410, Indonesia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 19, 2022
• Study Start: July 19, 2019
• Primary Completion: March 1, 2020
• Study Completion: April 8, 2020
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

ID (1)