TWB-103 for Adult Patients With Split-Thickness Skin Graft Donor Site Wounds (NCT02737748) | Clinical Trial Compass
CompletedPhase 1/2
TWB-103 for Adult Patients With Split-Thickness Skin Graft Donor Site Wounds
Japan, Taiwan48 participantsStarted 2017-07-06
Plain-language summary
Primary objective:
1. To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW) for Phase I in terms of Incidence of treatment-related AEs and SAEs (including infections and bleeding)
2. To evaluate the efficacy for Phase I+II of TWB-103 in split-thickness skin graft donor site wounds (DSW) in terms of The healing time from DSW creation to 100% re-epithelialization
Secondary objective:
1. To evaluate the efficacy of TWB-103 in split-thickness skin graft donor site wounds (DSW) in secondary efficacy endpoints
2. To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW) in secondary safety endpoints
Who can participate
Age range
20 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female/male patients, aged 20-65 years old
. Presenting a split-thickness skin graft donor site wound with a minimum size of 15 cm2 but no more than 100 cm2, with a minimum width of 3 cm and with an approximate thickness of 0.010\~0.012 inches. The graft cannot be harvested from a site from which a skin graft was previously obtained.
. If the primary wound is a result of a thermal or chemical burn, the total body surface area of the said wound must be less than 15%.
. Females of childbearing potential must have a documented negative serum pregnancy test done at the screening visit, which is within 2 weeks prior the DSW creation and the treatment
. Both male and female patients must agree to use highly effective contraceptives from signing informed consent to 30 days after the last dose administration.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Treatment-related AEs and SAEs (Including Infections and Bleeding)
Timeframe: Day 0~Day 28
2
The Healing Time From DSW Creation to the First 100% Re-epithelialization With Confirmation for at Least 10 Days Apart Assessed by the Investigator
Timeframe: Days 42 or earlier
3
Number of Participants Reached Confirmed Healing Within 28 Days.
. Willing to comply with the study protocol and to sign the Informed Consent Form
Exclusion criteria
. Female patients who are pregnant or lactating or planning a pregnancy and any male patient whose partner (wife) planning a pregnancy from signing informed consent to 30 days after the last dose administration.
. Clinically significant disease or condition that may compromise graft take and/or donor site healing (e.g. the presence of a bleeding disorder, capillary fragility, venous or arterial disorder directly affecting the donor site to be treated, known or suspected systemic malignancies, human immunodeficiency virus infection, renal or liver disease, uncontrolled diabetes mellitus, thrombocytopenia, vasculitis, poor nutritional status).
. Patients who are currently receiving or have received the following treatments within 4 weeks prior to study entry are excluded from the study:
. systemic or inhaled corticosteroids or immunosuppressant agents; or
. therapeutic doses of anticoagulants (e.g. Coumadin, Heparin, low molecular weight Heparin) for pre-existing medical conditions, for whom a dose interruption from Screening through the end of the study period is contraindicated.
. Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
. Hematologic disease, malignancy or hypo-immunity.