Antisepsis Regimen in the Surgical Treatment of Human Papilloma Virus Generated Cervical Lesions: Polyhexamethylene Biguanide Versus Chlorhexidine
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|ClinicalTrials.gov Identifier: NCT01740245|
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : December 4, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Antisepsis Regimen After Surgical Treatment of HPV Infected Lesions||Device: Chlorhexidine vaginal suppositories Device: Polyhexamethylene biguanide vaginal suppositories||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Active Comparator: Chlorhexidine||
Device: Chlorhexidine vaginal suppositories
|Experimental: Polyhexamethylene biguanide||
Device: Polyhexamethylene biguanide vaginal suppositories
- Bacterial vaginosis [ Time Frame: After three weeks by the day of the laser treatment ]Diagnosis of eventual bacterial infection is performed according to Amsel's criteria
- Change from baseline bleeding at 6 weeks [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)
- Bacterial vaginosis [ Time Frame: After six weeks by the day of laser treatment ]Diagnosis is performed according to the Amsel's criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740245
|Rome, Italy, 00132|