The Clinical Efficacy of Epidermal Growth Factor With Silver Sulfadiazine Cream Compared With Silver Zinc Sulfadiazine Cream on Acceleration of Partial Thickness Burn Wound Healing
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Time of Healing by Monitoring Duration (Days) at the Beginning of Treatment and the Day of Completely Epithelialization (Complete Epithelialization Means no Open Wound Exists as Confirmed by Two Surgeons).
研究概览
简要总结
Partial thickness burn wounds are most likely to heal within 2-3 weeks mainly by mechanism of epithelialization. However, it depends on the depth of the wounds and patient condition. Infection is one of the most common complications causing delay in wound healing which might affect to quality of patient's life. Generally, the standard treatment of partial thickness burn wound is topical 1% silver sulfadiazine cream. Previous studies had been reported the broad spectrum antimicrobial activity of silver sulfadiazine cream but it did not demonstrate the accelerating effect of wound healing. Therefore, the combination of substance which can promote wound healing to topical silver sulfadiazine cream might benefit for partial thickness burn wound treatment.
The objective of this study was to compare the results of partial thickness burn wound treatment at burn unit, Siriraj hospital with topical cream containing 1% silver sulfadiazine plus 6% epidermal growth factor (EGF) and 1% silver zinc sulfadiazine. The demographic data (age, sex, %body surface area burn), time of wound closure, pain and itching, dose and type of pain and itching medication, adverse effect of topical medication, some laboratory results and cost of expenses.
This is the prospective, double blinded, randomize-controlled study. The sample sizes were partial thickness burn wound patients who were treated at burn unit, Siriraj hospital. Patients were allocated into 2 groups receiving treatment with either topical silver sulfadiazine plus EGF or silver zinc sulfadiazine. All parameter data were analyzed with repeated measure ANOVA and independent t-test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-60 years.
- •Partial thickness burn wound more than 20%TBSA.
- •No underlying diseases that interfere wound healing such as chronic kidney disease, diabetes mellitus, liver disease, immunocompromised deficiency.
- •In case of reproductive age woman, they have to control the birth rate at least 4 weeks before study.
- •Patients who are willing to participate in the trial and to sign the informed consent form.
排除标准
- •Immunocompromised defects
- •Known allergy or hypersensitivity reaction to epidermal growth factor, silver sulfadiazine or other substances in formulation.
- •Pregnancy or lactation
研究组 & 干预措施
Epidermal growth factor with silver sulfadiazine cream
Epidermal growth factor with silver sulfadiazine cream was applied to the experimental wounds completely and then covered with sterile gauze. The wound was cleaned every 24 h and the cream was then applied again after cleaning process.
干预措施: Epidermal growth factor with silver sulfadiazine cream (Drug)
Silver zinc sulfadiazine cream
Silver sulfadiazine cream was applied to cover the controlled-wound completely and then covered with sterile gauze. The wound was cleaned every 24 h and the cream was then applied again after cleaning process.
干预措施: Silver zinc sulfadiazine cream (Drug)
结局指标
主要结局
Time of Healing by Monitoring Duration (Days) at the Beginning of Treatment and the Day of Completely Epithelialization (Complete Epithelialization Means no Open Wound Exists as Confirmed by Two Surgeons).
时间窗: On 28th day after admission
Time (days)for complete epithelialization (no open wound exists as determined by 2 surgeons) is the duration between the day of admission and the wound completely close without fluid leakage and are able to expose to environment without pain.
次要结局
- Clinical Safety of Epidermal Growth Factor With Silver Sulfadiazine Cream for Treatment of Partial Thickness Burn Wound.(On 28th day after admission)
研究者
Pornanong Aramwit, Pharm.D., Ph.D
Associate Professor
Chulalongkorn University
