Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Burn

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison Study OF Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Second Degree Burn

Conditions
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Burn

Intervention / Treatment
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* Biological: Autologous epidermal cell suspension
* Drug: Silver sulfadiazine ointment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous epidermal cell suspension group<br> | Biological: Autologous epidermal cell suspension<br>* 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<br>|
| Active Comparator: Silver sulfadiazine ointment group<br> | Drug: Silver sulfadiazine ointment<br>* the area with second degree burn dresses by silver sulfadiazine ointment and dressing change each 12 hour till 10 day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | up to 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar formation | Observe patient and take photo | After 2 month | 
| Post inflammatory hyperpigmentation | Observe patient and take photo | After 2 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burn, Epidermal cell suspension