Evaluation of the Effectiveness of a Gel Containing a Propionibacterium Extract in Wound Healing and Symptom Relief, Such as Pain, Itching, and Burning, in the Postoperative Period of Open Excisional Hemorrhoidectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Degree of epithelialization
研究概览
简要总结
This multicenter randomized controlled phase IV trial aims to compare the clinical efficacy of a gel containing a Propionibacterium extract and a gel with hyaluronic acid and silver sulfadiazine in the degree of epithelialization of post-operative wounds of open excisional hemorrhoidectomy.
The main questions it aims to answer are:
- To compare the efficacy of the two medical devices in the degree of epithelialization in the postoperative period of open excisional hemorrhoidectomy, at 0, 10, 20 and 40 days from the beginning of treatment.
- To evaluate the effectiveness of these devices in alleviating: pain, itching, burning, and the type of bowel habit Participants will be randomized, at the beginning of the study, to one of the two treatments, and the efficacy of the two medical devices will be evaluated at 0, 10, 20 and 40 days from the start of treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Open excisional hemorrhoidectomy, with removal of at least 3 groups
- •Age between 18 and 75 years
排除标准
- •Patients who do not consent to the study
- •Opioid-dependent patients, chronic use of analgesics
- •Fecal incontinence
- •Anorectal neoplasms
- •Immunosuppressive treatments (e.g., chemotherapy, radiotherapy, etc.)
- •Chronic inflammatory bowel diseases
- •Pregnancy
- •Patients with major psychiatric disorders
- •Known allergy to the components of the treatments under study
研究组 & 干预措施
Gel containing a Propionibacterium extract
干预措施: Gel containing a Propionibacterium extract (Device)
Hyaluronic acid and silver sulfadiazine
干预措施: Hyaluronic acid and silver sulfadiazine (Drug)
结局指标
主要结局
Degree of epithelialization
时间窗: From baseline to visit 3 (40 days after the start of the treatment)
The degree of epithelialization of the fissure was determined at each visit and stratified using 3 levels (1 to 3) corresponding to: 1. \< 50% 2. \> 50% 3. 100% (complete healing)
次要结局
- Burning and pain(From baseline to visit 3 (40 days after the start of the treatment))
- Bowel movements(At visit 3 (40 days after the start of the treatment))
- Itching(From baseline to visit 3 (40 days after the start of the treatment))
研究者
Simona Deidda
Assistant professor
University of Cagliari