Antisepsis Regimen in the Surgical Treatment of Human Papilloma Virus Generated Cervical Lesions: Polyhexamethylene Biguanide Versus Chlorhexidine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
- 主要终点
- Bacterial vaginosis
研究概览
简要总结
Treatments for the macroscopic or pathologic lesions caused by HPV infection can be classified as topical, surgical, destructive, or immunomodulatory. Post surgical treatments generally consist of analgesic, anti-inflammatory and topical antimicrobial agents to reduce the risk of local infections.
The aim of this study is to compare the efficacy and safety of polyhexamethylene biguanide-based vaginal suppositories to a similar chlorhexidine-based treatment, in the post recovery regimen after surgical treatment of cervical lesions.
Women who underwent to CO2 laser therapy for cervical lesions are randomly assigned to receive 10 days of antiseptic treatment with chlorhexidine digluconate vaginal suppositories, or polyhexamethylene biguanide vaginal suppositories (Monogin® / BiguanelleTM vaginal suppositories, Lo.Li.Pharma, Italy). A weekly follow-up check was performed for 6 weeks.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •positive colposcopy examination
- •positive Papanicolaou smear
- •pathological biopsy
- •physical ablation by CO2 laser therapy for a number of lesions included between 3 and 5
排除标准
- •pregnancy
结局指标
主要结局
Bacterial vaginosis
时间窗: After six weeks by the day of laser treatment
Diagnosis is performed according to the Amsel's criteria
Change from baseline bleeding at 6 weeks
时间窗: At weekly intervals by the day of laser treatment
Visual scoring was assessed depending on the grade of the defect (from 1 to 3)
Change from baseline healing process at 6 weeks
时间窗: At weekly intervals by the day of laser treatment
Visual scoring for healing is assessed depending on the grade of the defect (from 1 to 3)
Change from baseline irritation status at 6 weeks
时间窗: At weekly intervals by the day of laser treatment
Visual scoring for irritation is assessed depending on the grade of the defect (from 1 to 3)
次要结局
未报告次要终点