Cold Argon Plasma Application in the Wound Treatment After Open Hemorrhoidectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Wound healing
研究概览
简要总结
This is single-center, prospective, randomized study
详细描述
This study will include patients with 3-4 stage hemorrhoids. They will undergo an operation of open hemorrhoidectomy. Patients will be divided into a study group and a control group. Study group patients during a post-operation period except a standard treatment (antiseptic solutions and antibacterial and wound healing ointments) of a post-operation wound will be treated with cold argon plasma. Control group patients will be treated with a standard treatment. Wound healing speed will be researched.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •3-4 stage hemorrhoids
- •3 hemorrhoids
排除标准
- •patients underwent anal canals intervention
- •acute hemorrhoids
- •inflammatory bowel disease
- •co-morbidity diseases of anal canal and perianal area
- •concurrent conditions in the stage of decompensation
研究组 & 干预措施
Patients after open hemorrhoidectomy (study group)
Patients to whom during a post-operation period cold argon plasma and a standard treatment will be treated. Cold argon plasma will be applied during 4 minutes at one session on the 2nd, 3rd, 4th, 5th, 6th, 7th, 8th, 14th, 21nd, 30th day after operation. The usage of antibacterial and wound healing ointments daily.
干预措施: Wound healing (Procedure)
Patients after open hemorrhoidectomy (control group)
Patients who during a post-operation period will be treated with a standard treatment.The usage of antibacterial and wound healing ointments daily.
干预措施: Wound healing (Procedure)
结局指标
主要结局
Wound healing
时间窗: 30 days
Total wound healing will be assessed with the help of cytological and macroscopic methods.In the cytological method the presence of fibroblasts, mature epithelial cells, scar tissue formation and the absence of inflammation will be the criterion of wound healing, as well as the presence of macroscopic features of wound epithelialization.
次要结局
- Pain Intensity Measure(2, 3, 4, 5, 6, 7, 8, 14, 21, 30 days)
- Life quality(before operation, 8 days, 30 days)
- Microbiological contamination of wound area(2, 8, 14, 21, 30 days)