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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine | Active Comparator |
| |
| Polyhexamethylene biguanide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine vaginal suppositories | Device |
| ||
| Polyhexamethylene biguanide vaginal suppositories |
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial vaginosis | Diagnosis of eventual bacterial infection is performed according to Amsel's criteria | After three weeks by the day of the laser treatment |
| Change from baseline bleeding at 6 weeks | Visual scoring was assessed depending on the grade of the defect (from 1 to 3) | At weekly intervals by the day of laser treatment |
| Change from baseline healing process at 6 weeks | Visual scoring for healing is assessed depending on the grade of the defect (from 1 to 3) | At weekly intervals by the day of laser treatment |
| Change from baseline irritation status at 6 weeks | Visual scoring for irritation is assessed depending on the grade of the defect (from 1 to 3) | At weekly intervals by the day of laser treatment |
| Bacterial vaginosis | Diagnosis is performed according to the Amsel's criteria | After six weeks by the day of laser treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AGUNCO | Rome | 00132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12353208 | Background | Wiley DJ, Douglas J, Beutner K, Cox T, Fife K, Moscicki AB, Fukumoto L. External genital warts: diagnosis, treatment, and prevention. Clin Infect Dis. 2002 Oct 15;35(Suppl 2):S210-24. doi: 10.1086/342109. | |
| 20829657 | Background | Kaehn K. Polihexanide: a safe and highly effective biocide. Skin Pharmacol Physiol. 2010;23 Suppl:7-16. doi: 10.1159/000318237. Epub 2010 Sep 8. |
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| Device |
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| 20551215 | Background | Koburger T, Hubner NO, Braun M, Siebert J, Kramer A. Standardized comparison of antiseptic efficacy of triclosan, PVP-iodine, octenidine dihydrochloride, polyhexanide and chlorhexidine digluconate. J Antimicrob Chemother. 2010 Aug;65(8):1712-9. doi: 10.1093/jac/dkq212. Epub 2010 Jun 15. |
| 18364400 | Background | Muller G, Kramer A. Biocompatibility index of antiseptic agents by parallel assessment of antimicrobial activity and cellular cytotoxicity. J Antimicrob Chemother. 2008 Jun;61(6):1281-7. doi: 10.1093/jac/dkn125. Epub 2008 Mar 25. |