Antisepsis Regimen in the Surgical Treatment of Human Papilloma Virus Generated Cervical Lesions: Polyhexamethylene Biguanide Versus Chlorhexidine
NCT ID: NCT01740245
Last Updated: 2012-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
INTERVENTIONAL
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Groups
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Chlorhexidine
Chlorhexidine vaginal suppositories
Polyhexamethylene biguanide
Polyhexamethylene biguanide vaginal suppositories
Interventions
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Chlorhexidine vaginal suppositories
Polyhexamethylene biguanide vaginal suppositories
Eligibility Criteria
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Inclusion Criteria
* positive Papanicolaou smear
* pathological biopsy
* physical ablation by CO2 laser therapy for a number of lesions included between 3 and 5
Exclusion Criteria
20 Years
40 Years
FEMALE
No
Sponsors
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AGUNCO Obstetrics and Gynecology Centre
OTHER
Responsible Party
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Locations
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AGUNCO
Rome, , Italy
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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CHX-PHMB
Identifier Type: -
Identifier Source: org_study_id