Donor Site Complication Clinical Trial
Official title:
A Phase I/II Study to Evaluate the Safety and Efficacy of TWB-103 in Adult Patients With Split-Thickness Skin Graft Donor Site Wounds (DSW)
Verified date | June 2023 |
Source | Transwell Biotech Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 48 |
Est. completion date | May 7, 2021 |
Est. primary completion date | May 7, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Female/male patients, aged 20-65 years old 2. 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. 3. 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%. 4. 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 5. Both male and female patients must agree to use highly effective contraceptives from signing informed consent to 30 days after the last dose administration. 6. Willing to comply with the study protocol and to sign the Informed Consent Form Exclusion Criteria: 1. 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. 2. 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). 3. Patients who are currently receiving or have received the following treatments within 4 weeks prior to study entry are excluded from the study: 1. systemic or inhaled corticosteroids or immunosuppressant agents; or 2. 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. 4. Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis. 5. Hematologic disease, malignancy or hypo-immunity. 6. History of HIV or congenital immunodeficiency. 7. History of alcoholism or drug abuse. 8. Have used any tobacco product within 1 week prior to Day 0. 9. Patients previously treated with any cell-based product, including autologous tissue at the treatment site. 10. Received an investigational drug, device or biological/bioactive treatment within 30 days prior to Screening Visit. 11. Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the trial treatment. 12. History of sensitivity to bovine or porcine origin materials, or human serum albumin. 13. DSWs located in the face, over joints, lower legs or the buttocks 14. Any of the following hematologic abnormalities: (Hemoglobin < 10.0 g/dL, ANC < 1,500/µL, platelets < 75,000 /µL) 15. Any of the following serum chemistry abnormalities: (Total bilirubin > 1.5 × ULN, AST or ALT > 3 × ULN, gamma-GT > 2.5 x ULN, Alk-P > 2.5 x ULN, serum albumin < 2.7 g/dL, creatinine >1.5 x ULN, any other = Grade 2 laboratory abnormality (based on CTCAE) at baseline (other than those listed above) 16. DSWs in area with active skin infection or with skin condition that is considered highly susceptible to infection judged by the investigator |
Country | Name | City | State |
---|---|---|---|
Japan | Nippon Medical School | Tokyo | |
Japan | Tokyo Medical University | Tokyo | |
Taiwan | Tri-Service General Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Transwell Biotech Co., Ltd. | A2 Healthcare Taiwan Corporation |
Japan, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Treatment-related AEs and SAEs (Including Infections and Bleeding) | The number of participants with treatment-related AEs and SAEs (including infections and bleeding) will be observed for the 7 patients in Phase I | Day 0~Day 28 | |
Primary | The Healing Time From DSW Creation to the First 100% Re-epithelialization With Confirmation for at Least 10 Days Apart Assessed by the Investigator | The healing time from DSW creation to the first 100% re-epithelialization with confirmation for at least 10 days apart assessed by the investigator for all patients in Phase I and II. | Days 42 or earlier | |
Primary | Number of Participants Reached Confirmed Healing Within 28 Days. | The number of participants in Phase I and II reached confirmed healing by the investigator within 28 days. | Days 42 or earlier | |
Secondary | The Healing Time From DSW Creation to the First 100% Re-epithelialization With Confirmation for at Least 10 Days Apart, Assessed by the First Additional Evaluator | The healing time from DSW creation to the first 100% re-epithelialization with confirmation for at least 10 days apart assessed by the investigator for all patients in Phase I and II. The first additional evaluator judged the healing status by looking at the photos of DSW. | Days 42 or earlier | |
Secondary | Number of Participants With Complete Wound Closure at Day 7, 10 and 14 After DSW Creation. | Complete wound closure is defined as skin 100% re-epithelialization without drainage or dressing requirements. This endpoint will be in all patients in Phase I and II. | Day 7, 10 and 14 | |
Secondary | The Healing Percentage of Wounds (Ratio of Healing Area and Original Area) at Days 7, 10 and 14 After DSW Creation | The healing percentage of wounds will be calculated based on the healing area measured on Day 7, 10 and 14, comparing to the original area measured on Day 0 for all patients in Phase I and II. | Day 7, 10 and 14 | |
Secondary | The Pain Change From Baseline to Post-wound Creation Visits Based on Short-form McGill Pain Questionnaire Score | All patients in Phase I and II will evaluate the pain based on Short-form McGill pain questionnaire at each visit.
The visual analogue scale (VAS) for pain is a continuous scale comprised of a horizontal line, usually, 10 cm (= 100 mm) in length, scored from 0 (none) to 10 (extreme). On this scale, a higher score in VAS indicates the worse pain. |
Days 3, 7, 10, 14, 28, 42, Day 90/180/270/360 from Day 28 or 42 | |
Secondary | Number of Participants With AEs and SAEs | The number of participants with AEs and SAEs will be analyzed for all patients in Phase I and II. | Screening~ Day 360 from Day 28 or 42 | |
Secondary | Changes in Post-treatment Physical Examination Compared to Baseline | Changes in post-treatment physical examination will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 | |
Secondary | Changes in Post-treatment Vital Signs-pulse Rate Compared to Baseline | Changes in post-treatment vital signs-pulse rate will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 | |
Secondary | Changes in Post-treatment Vital Signs-body Temperature Compared to Baseline | Changes in post-treatment vital signs-body temperature will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 | |
Secondary | Changes in Post-treatment Vital Signs-systolic Blood Pressure Compared to Baseline | Changes in post-treatment vital signs-systolic blood pressure will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 | |
Secondary | Changes in Post-treatment Vital Signs-diastolic Blood Pressure Compared to Baseline | Changes in post-treatment vital signs-diastolic blood pressure will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 | |
Secondary | Changes in Post-treatment General Laboratory Assessment-hematology-white Blood Cells Compared to Baseline | Changes in post-treatment general laboratory assessment-hematology-white blood cells will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 | |
Secondary | Changes in Post-treatment General Laboratory Assessment-hematology-neutrophils Compared to Baseline | Changes in post-treatment general laboratory assessment-hematology-neutrophils will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 | |
Secondary | Changes in Post-treatment General Laboratory Assessment-hematology-Hemoglobin Compared to Baseline | Changes in post-treatment general laboratory assessment-hematology-hemoglobin will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 | |
Secondary | Changes in Post-treatment General Laboratory Assessment-hematology-Hematocrit Compared to Baseline | Changes in post-treatment general laboratory assessment-hematology-hematocrit will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 | |
Secondary | Changes in Post-treatment General Laboratory Assessment-hematology-platelets Compared to Baseline | Changes in post-treatment general laboratory assessment-hematology-platelets will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 | |
Secondary | Changes in Post-treatment General Laboratory Assessment-hematology-red Blood Cells Compared to Baseline | Changes in post-treatment general laboratory assessment-hematology-red blood cells will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 | |
Secondary | Changes in Post-treatment General Laboratory Assessment-biochemistry-aspartate Aminotransferase Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-aspartate aminotransferase will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 | |
Secondary | Changes in Post-treatment General Laboratory Assessment-biochemistry-alanine Aminotransferase Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-alanine aminotransferase will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 | |
Secondary | Changes in Post-treatment General Laboratory Assessment-biochemistry-serum Creatinine Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-serum creatinine will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 | |
Secondary | Changes in Post-treatment General Laboratory Assessment-biochemistry-blood Urea Nitrogen Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-blood urea nitrogen will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 | |
Secondary | Changes in Post-treatment General Laboratory Assessment-biochemistry-Albumin Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-albumin will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 | |
Secondary | Changes in Post-treatment General Laboratory Assessment-biochemistry-bilirubin Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-bilirubin will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 | |
Secondary | Changes in Post-treatment General Laboratory Assessment-biochemistry-gamma-glutamyl Transferase Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-gamma-glutamyl transferase will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 | |
Secondary | Changes in Post-treatment General Laboratory Assessment-biochemistry-alkaline Phosphatase Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-alkaline phosphatase will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 | |
Secondary | Number of Participants With Treatment-related AEs and SAEs (Including Infections and Bleeding) | The number of participants with treatment-related AEs and SAEs (including infections and bleeding) will be observed for all patients in Phase I and II | Screening~ Day 360 from Day 28 or 42 | |
Secondary | The Number of Censored Subjects Assessed by the Investigator and the First Additional Evaluator | The number of censored subjects in Phase I and II assessed by the investigator and the first additional evaluator. The first additional evaluator judged the healing status by looking at the photos of DSW. If the 100% re-epithelialization was not observed by Day 28 visit, the healing time was censored on the day of the last visit up to Day 28 visit. If the 100% re-epithelialization was observed by Day 28 visit but no confirmation was made, the healing time was censored on day of the last visit up to Day 28 visit. | Days 42 or earlier |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03663036 -
Arthroscopic Superior Capsular Reconstruction With Fascia Lata Autograft - Survivorship of the Autograft Analysis
|
N/A | |
Completed |
NCT01670201 -
An Investigation to Evaluate a New Donor Site Dressing in Surgical Burn Patients
|
N/A | |
Completed |
NCT04422925 -
s100β, NSE n GFAP in Living Donor Hepatectomy and Delirium
|
||
Recruiting |
NCT06030791 -
BTB Graft Harvest and Donor Site Morbidity After ACL Reconstruction
|
||
Completed |
NCT04050124 -
Impact of Prisma on Donor Site Pain
|
N/A | |
Not yet recruiting |
NCT04997863 -
Clinical Efficacy and Safety of Sericin Hydrogel Sheet Impregnated With Bird's Nest Extract
|
N/A | |
Not yet recruiting |
NCT03850119 -
Nanofat on Wound Healing and Scar Formation
|
N/A | |
Completed |
NCT04490213 -
Scarring At Donor Sites After Split-Thickness Skin Graft.
|
||
Terminated |
NCT03992820 -
Transcutaneous Electrical Nerve Stimulation for Local Anaesthesia
|
N/A | |
Completed |
NCT04403503 -
The Influence of Tissue Adhesive to Palatal Donor Site Healing.
|
N/A | |
Completed |
NCT03209167 -
Comparing Patient Satisfaction of the Abdomen After DIEAP Procedure and Conventional Abdominoplasty
|
N/A | |
Recruiting |
NCT04743375 -
Clinical Efficacy of Silk Sericin Dressing With Collagen for Split-thickness Skin Graft Donor Site Treatment
|
N/A | |
Recruiting |
NCT05740033 -
Radial Forearm Donor Site Closure
|
N/A | |
Recruiting |
NCT04186273 -
Clinical Safety and Scar Prevention Study of a Topical Antifibrotic Compound FS2.
|
Phase 2 | |
Completed |
NCT04692961 -
Change in the Lower Leg Muscle Stiffness Following Peroneal Artery-based Flap
|
N/A | |
Completed |
NCT06044519 -
A Single Center Trial of Donor Site Wound Dressings After Split Thickness Skin Grafting.
|
Phase 4 | |
Completed |
NCT04867070 -
Pain Management in Laparoscopic Living-donor Nephrectomy: The Impact of Erector Spinae Plane Block (ESPB) on Perioperative Period
|
N/A | |
Terminated |
NCT02671344 -
Determining the Genetic Profile in Semen Donors With Pregnancy, Donor Versus no Pregnancy Obtained in TRA
|