A Phase 2 interventional study of Autologous epidermal cell suspension and Silver sulfadiazine ointment in Burn, sponsored by SCARM Institute, Tabriz, Iran. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-03-18.
Sponsored by SCARM Institute, Tabriz, Iran · Phase 2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Biological: Autologous epidermal cell suspension
Drug: Silver sulfadiazine ointment
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
the area with second degree burn dresses by silver sulfadiazine ointment and dressing change each 12 hour till 10 day
Change in re-epithelization rate with autologous epidermal cell suspension graft from Baseline
Measurement the percentage of re-epithelization ( 0-30%=poor; 30-60%=moderate; 60-90%=good; \>90%=complete)
Time frame: up to 20 days
Change in re-epithelization rate with silver sulfadiazine ointment from Baseline
Measure percentage of re-epithelization ( 0-30%=poor; 30-60%=moderate; 60-90%=good; \>90%=complete)
Time frame: up to 20 days
Scar formation
Observe patient and take photo
Time frame: After 2 month
Post inflammatory hyperpigmentation
Observe patient and take photo
Time frame: After 2 month
Plan to share: No
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
SCARM Institute, Tabriz, Iran