Effect of Topical Turkish Propolis Application on Burn Healing in Experimental Burn Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- bulla
研究概览
简要总结
This experimental study will be carried out at Ege University Laboratory Animals Application and Research Center to identify the efficacy of 10% propolis and 15% propolis on wound healing in a second-degree superficial burn wound.
In the study, 36 adult (8-12 week old) Wistar-Albino rats with a weight of 200-300 grams will be used in each group. Each group will include 6 rats. Stratified randomization will be used to randomize rats according to their gender and weight. After randomization, a burnt area will be created on the back of the rats and dressings will be made every day.
Following the creation of the burn, biopsy samples will be taken on the 3rd, 7th, 14th and 21st days and at the light microscopic level; bulla, erythema, oedema, burn depth, inflammatory cell infiltration, necrosis, ulceration, angiogenesis, neovascularization, fibroblast proliferation, collagenization, epithelization, fibrosis, the number of hair follicles and damage to the skin attachments.
In the immunohistochemical examination of biopsy samples, samples will be taken for the evaluation of superoxide dismutase, malondialdehyde, myeloperoxidase in the evaluation of the tumour necrosis factor-alpha, interleukin-1β and oxidative stress in the EBB period in order to evaluate the acute phase reactants. Fungal and gram staining will be done in order to determine the pathogen reproduction in biopsy samples taken on the 3rd and 7th day. Masson trichrome in order to detect fibrosis in biopsy samples taken on the 14th and 21st day; Hydroxyproline examination will be examined in order to evaluate collagen formation.
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
- Single (Outcomes Assessor)
盲法说明
the researcher who will analyze the primary outcome of the study will not know which group of animals the samples were taken from.
入排标准
- 年龄范围
- 8 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult (8-12 weeks)
- •200-300 grams
- •Wistar-Albino rat
- •with 4 second-degree superficial contact burn are at its back.
排除标准
- •the death of the rat in the research process
结局指标
主要结局
bulla
时间窗: 21st day day of the research
examination of the skin at the light microscopic level. Erythemawill be considered as present or absent.
fibroblast proliferation
时间窗: 21st day of the research
examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.
wound size
时间窗: 21 days
photos will be taken every day to determine the wound size
edema
时间窗: 21st day of the research
examination of the skin at the light microscopic level. Edema will be considered as present or absent.
ulceration
时间窗: 21st day of the research
examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.
angiogenesis
时间窗: 21st day of the research
examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.
inflammatory cell infiltration
时间窗: 21st day of the research
examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.
necrosis
时间窗: 21st day of the research
examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.
epithelization
时间窗: 21st day of the research
examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.
collagenization
时间窗: 21st day of the research
examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.
microorganism colonization
时间窗: 21st day of the research
examination of the skin at the light microscopic level. Colonization will be considered as present or absent.
次要结局
未报告次要终点
研究者
ESRA ARDAHAN AKGUL
Research Assistant
Izmir Katip Celebi University