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 range20 Years – 65 Years
SexALL
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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.
✓. 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.
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.
✕. 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.
✕. History of HIV or congenital immunodeficiency.