Skin Graft ScarNCT05335720
Efficacy and Safety Evaluation of EASYEF® in Acute Wound (Split-thickness Skin Graft Donor Site)
A study testing rhEGF in people with Skin Graft Scar and Split-Thickness Skin Graft (STSG), run by PT. Daewoong Infion at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Graft Scar, Split-Thickness Skin Graft (STSG)
- What is being tested?
- rhEGF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndonesia
- Study dates
- 19 Jul 2019to 8 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Evaluate the Efficacy and Safety of EASYEF® in Acute Wound (Split-thickness Skin Graft Donor Site)
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.
Read the 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)
- Being tested
- rhEGF
- Keywords
- EGF, Epidermal Growth Factor, rhEGF, recombinant human Epidermal Growth Factor, Acute wound, Skin graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhEGFDrug
Also called EASYEF®
EASYEF® spray 50 mcg, sprayed twice a day for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: rhEGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (2)
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.
Measured: 14 days
Photograph evaluation
During the change of dressing in the morning and evening, photograph was taken to evaluate the re-epithelization improvement.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start19 Jul 2019
- Primary completion1 Mar 2020
- Study completion8 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Graft ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT. Daewoong Infion
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Equilab International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335720
- Sponsor's protocol ID
- DW_EGFCS
- Status last verified
- Jul 2022
- First submitted
- 6 Apr 2022
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Efficacy and Safety of EASYEF® in Acute Wound (Split-thickness Skin Graft Donor Site)
- ClinicalTrials.gov ID
- NCT05335720
- Acronym / sponsor ID
- DW_EGFCS
- Conditions
- Skin Graft Scar, Split-Thickness Skin Graft (STSG)
- Keywords
- EGF, Epidermal Growth Factor, rhEGF, recombinant human Epidermal Growth Factor, Acute wound, Skin graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- PT. Daewoong InfionIndustry (pharma, biotech, devices)
- Collaborators
- Equilab International
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Drug: rhEGF1. 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. |
| Cohort 2 | Active comparator | Drug: rhEGF1. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhEGFAlso: EASYEF®EASYEF® spray 50 mcg, sprayed twice a day for 14 days. | Drug | Cohort 1, Cohort 2 |
Primary outcome
Comparison of the wound healing time of each skin graft donor site
Time frame: 14 days
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.
2 secondary outcomes
Adverse Events
Time frame: 14 days
Photograph evaluation
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rhEGF in people with Skin Graft Scar and Split-Thickness Skin Graft (STSG), run by PT. Daewoong Infion at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the wound healing time of each skin graft donor site (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.