Burn Wound Clinical Trial
Official title:
Non-cultured Autologous Keratinocyte Suspension for Treatment of Deep Dermal Burn and Post-Burn Raw Area Versus Traditional Split Skin Graft
NCT number | NCT03675568 |
Other study ID # | NCAKS |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | November 1, 2018 |
Est. completion date | March 31, 2021 |
Verified date | October 2018 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A study comparing effect of non-cultured autologous keratinocyte suspension on burn wounds treatment compared with traditional split skin graft
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 31, 2021 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Deep dermal burns more than 10% total body surface area which require surgical debridement and epidermal replacement. - Post-burn raw area more than 10% total body surface area Exclusion Criteria: - Presence of pre-existing local and systemic bacterial infections. - Pre-existing medical conditions that would interfere with wound healing (uncontrolled diabetes mellitus, malignancy, congestive heart failure, autoimmune disease, renal failure, corticosteroids and immunosuppressive drugs). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Deitch EA, Wheelahan TM, Rose MP, Clothier J, Cotter J. Hypertrophic burn scars: analysis of variables. J Trauma. 1983 Oct;23(10):895-8. — View Citation
Fraulin FO, Bahoric A, Harrop AR, Hiruki T, Clarke HM. Autotransplantation of epithelial cells in the pig via an aerosol vehicle. J Burn Care Rehabil. 1998 Jul-Aug;19(4):337-45. — View Citation
Hefton JM, Madden MR, Finkelstein JL, Shires GT. Grafting of burn patients with allografts of cultured epidermal cells. Lancet. 1983 Aug 20;2(8347):428-30. — View Citation
Hunyadi J, Farkas B, Bertényi C, Oláh J, Dobozy A. Keratinocyte grafting: a new means of transplantation for full-thickness wounds. J Dermatol Surg Oncol. 1988 Jan;14(1):75-8. — View Citation
Jackson PC, Hardwicke J, Bamford A, Nightingale P, Wilson Y, Papini R, Moiemen N. Revised estimates of mortality from the Birmingham Burn Centre, 2001-2010: a continuing analysis over 65 years. Ann Surg. 2014 May;259(5):979-84. doi: 10.1097/SLA.0b013e31829160ca. — View Citation
McGwin G Jr, Cross JM, Ford JW, Rue LW 3rd. Long-term trends in mortality according to age among adult burn patients. J Burn Care Rehabil. 2003 Jan-Feb;24(1):21-5. — View Citation
Osler T, Glance LG, Hosmer DW. Simplified estimates of the probability of death after burn injuries: extending and updating the baux score. J Trauma. 2010 Mar;68(3):690-7. doi: 10.1097/TA.0b013e3181c453b3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | mean Hospital stay | Number of days patient stays admitted | 1 month | |
Secondary | mean healing time | Number of days until 95% healing | 1 month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03948360 -
Safety Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds
|
N/A | |
Completed |
NCT04277182 -
Effect of Propolis Application on Burn Healing
|
N/A | |
Enrolling by invitation |
NCT00978705 -
Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood
|
Phase 3 | |
Active, not recruiting |
NCT04828304 -
PLASOMA Ultimate Safety & Efficacy Study
|
N/A | |
Not yet recruiting |
NCT05649332 -
Study to Evaluate the Performance and Safety of the Medical Device Argogen
|
N/A | |
Recruiting |
NCT05593523 -
Fluorescence-based Detection of Inflammation and Necrosis to Inform Surgical Decision-making and Enhance Outcomes
|
||
Completed |
NCT06280053 -
HealiAid in the Treatment of Different Wounds
|
N/A | |
Enrolling by invitation |
NCT06103409 -
MSCs for the Treatment of Burn Wounds
|
Phase 1/Phase 2 | |
Recruiting |
NCT05796492 -
Ultrasound Treatment on Wound Healing Time
|
N/A | |
Enrolling by invitation |
NCT04725071 -
Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults
|
N/A | |
Suspended |
NCT02577120 -
Wound Healing Endpoint and Recurrence
|
Phase 4 | |
Active, not recruiting |
NCT05341427 -
DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF PULSED ELECTROMAGNETIC THERAPY ON BURN WOUND HEALING
|
N/A | |
Completed |
NCT04753723 -
The Use of a Platform Wound Device for Reducing Infection
|
Phase 4 | |
Terminated |
NCT03723590 -
A Clinical Evaluation of an Esterified Hyaluronic Acid Matrix in Burn Patients for STSG
|
N/A | |
Not yet recruiting |
NCT04011306 -
A Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns
|
N/A | |
Recruiting |
NCT05404191 -
Prediction Rules for Low Level Laser on Burn Wounds
|
N/A | |
Completed |
NCT02982096 -
Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique
|
N/A |