Burn
Conditions
Keywords
Burn, Epidermal cell suspension
Brief summary
Different medical treatments are available for treatment of skin burns such as skin grafts and silver sulfadiazine ointment. These treatments are used for second degree burn as routine technique in burns units. Cell therapy is a new approach for treatment of skin disease.In this study we use autologous epidermal cell suspension to achieve better cosmetic and functional results in treatment of second degree burn.
Detailed description
In this study 20 patients in Burn Department of Sina Hospital Tabriz, with at least 2 areas of second degree burn randomly choose. First skin samples are taken from normal skin by 4mm punch and send to the laboratory for preparation of epidermal cell suspension and this suspension is transferred to the one area of second degree burn in each patient and the other area in the same patient dresses by silver sulfadiazine ointment. The dressing changes are followed up for 12h for first assessment of therapy until 10th day after intervention. In the days of 5, 10, 15 and 20 the percentage of re-epithelization for each treatment will be measured. After 2 months, patients are visited and any complications check for scar formation, pain, post inflammatory hyper-pigmentation.
Interventions
BIOLOGICALAutologous epidermal cell suspension
First skin samples taken from normal skin by 4mm punch will be send to laboratory for preparation of epidermal cell suspension and this suspension transfer to one area of second degree burn
DRUGSilver sulfadiazine ointment
the area with second degree burn dresses by silver sulfadiazine ointment and dressing change each 12 hour till 10 day
Sponsors
SCARM Institute, Tabriz, Iran
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Healthy patient with second degree burn admitted in burn unit
Exclusion criteria
* Pregnancy-lactation * Immunosuppression like receiving chemotherapy or radiotherapy * Patient unsatisfied to going on study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in re-epithelization rate with autologous epidermal cell suspension graft from Baseline | up to 20 days | Measurement the percentage of re-epithelization ( 0-30%=poor; 30-60%=moderate; 60-90%=good; \>90%=complete) |
| Change in re-epithelization rate with silver sulfadiazine ointment from Baseline | up to 20 days | Measure percentage of re-epithelization ( 0-30%=poor; 30-60%=moderate; 60-90%=good; \>90%=complete) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scar formation | After 2 month | Observe patient and take photo |
| Post inflammatory hyperpigmentation | After 2 month | Observe patient and take photo |
Countries
Iran
Outcome results
None listed