Antisepsis Regimen After Surgical Treatment of HPV Infected Lesions Clinical Trial
| NCT number | NCT01740245 |
| Other study ID # | CHX-PHMB |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | November 28, 2012 |
| Last updated | November 30, 2012 |
| Verified date | June 2012 |
| Source | AGUNCO Obstetrics and Gynecology Centre |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 20 Years to 40 Years |
| Eligibility |
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 |
N/A
| Country | Name | City | State |
|---|---|---|---|
| Italy | AGUNCO | Rome |
| Lead Sponsor | Collaborator |
|---|---|
| AGUNCO Obstetrics and Gynecology Centre |
Italy,
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. Review. — View Citation
Koburger T, Hübner 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. — View Citation
Müller 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Bacterial vaginosis | Diagnosis of eventual bacterial infection is performed according to Amsel's criteria | After three weeks by the day of the laser treatment | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Bacterial vaginosis | Diagnosis is performed according to the Amsel's criteria | After six weeks by the day of laser treatment |