Comparison Study OF Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Second Degree Burn
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in re-epithelization rate with autologous epidermal cell suspension graft from Baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy patient with second degree burn admitted in burn unit
排除标准
- •Pregnancy-lactation
- •Immunosuppression like receiving chemotherapy or radiotherapy
- •Patient unsatisfied to going on study
研究组 & 干预措施
Autologous epidermal cell suspension group
干预措施: Autologous epidermal cell suspension (Biological)
Silver sulfadiazine ointment group
干预措施: Silver sulfadiazine ointment (Drug)
结局指标
主要结局
Change in re-epithelization rate with autologous epidermal cell suspension graft from Baseline
时间窗: 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
时间窗: up to 20 days
Measure percentage of re-epithelization ( 0-30%=poor; 30-60%=moderate; 60-90%=good; \>90%=complete)
次要结局
- Scar formation(After 2 month)
- Post inflammatory hyperpigmentation(After 2 month)