Clinical trial NCT01740245: Antisepsis Regimen in the Surgical Treatment of Human Papilloma Virus Generated Cervical Lesions: Polyhexamethylene Biguanide Versus Chlorhexidine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Antisepsis Regimen After Surgical Treatment of HPV Infected Lesions
Keywords: Laser therapy
Cervical lesions
Polyhexamethylene biguanide
Chlorhexidine
Lead sponsor: AGUNCO Obstetrics and Gynecology Centre
Sponsor class: OTHER
First posted: 2012-12-04
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* positive colposcopy examination
* positive Papanicolaou smear
* pathological biopsy
* physical ablation by CO2 laser therapy for a number of lesions included between 3 and 5

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Bacterial vaginosis
timeFrame: After three weeks by the day of the laser treatment
measure: Change from baseline bleeding at 6 weeks
timeFrame: At weekly intervals by the day of laser treatment
measure: Change from baseline healing process at 6 weeks
timeFrame: At weekly intervals by the day of laser treatment
measure: Change from baseline irritation status at 6 weeks
timeFrame: At weekly intervals by the day of laser treatment
measure: Bacterial vaginosis
timeFrame: After six weeks by the day of laser treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: AGUNCO
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.