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临床试验/NCT04275596
NCT04275596Unknown3 期

Impact of Topical Antiadhesion Therapy on Wound Healing and Postoperative Pain After Anal Surgery: A Randomized Double-blinded Controlled Study

Mansoura University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年2月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
50
试验地点
1
主要终点
Time to complete anal Wound healing

研究概览

简要总结

2QR-complex is a patented molecule extracted from Aloe vera barbadensis leaves that blocks the adhesion of pathogenic microbes to human epithelial cells and tissues [9]. Anti-adhesion therapy such as 2QR-complex has been suggested as an alternative to antibiotics in the treatment of bacterial infections. 2QR-complex based products have already shown comparable efficacy to antibiotics in treating mucosal infections such as bacterial vaginosis.

In the present study we aim to assess the efficacy of 2QR-complex in pain relief and promotion of anal wound healing after anal surgery. We presumed that anal discomfort and prolonged healing after surgery for anal fissure, fistula, and hemorrhoids may in part be due to contamination of the wound with fecal bacteria that colonize at the surgical site. Therefore, we assumed that the use of topical anti-adhesive 2QR-complex-based product may serve to minimize this negative impact on wound healing.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients of either sex with simple anal fistula, chronic anal fissure, or grade III/IV hemorrhoids will be included.

排除标准

  • Patients with other anal conditions, diabetic patients, patients under steroid or immunosuppressive therapy will be excluded.

研究组 & 干预措施

2QR complex

Active Comparator

Patients who undergo anal surgery will apply 2QR complex topical agent on the wound until healing

干预措施: 2QR complex (Drug)

Placebo

Active Comparator

Patients who undergo anal surgery will apply placebo cream on the wound until healing

干预措施: Placebo (Drug)

结局指标

主要结局

Time to complete anal Wound healing

时间窗: Six weeks after surgery

The time required to achieve complete Complete epithelization of the anal wound postoperatively

次要结局

  • Anal pain(one week, one month, two months after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sameh Emile

lecturer of surgery

Mansoura University

研究点 (1)

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