Antisepsis Regimen After Surgical Treatment of HPV Infected Lesions
Conditions
Keywords
Laser therapy, Cervical lesions, Polyhexamethylene biguanide, Chlorhexidine
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.
Interventions
DEVICEChlorhexidine vaginal suppositories
DEVICEPolyhexamethylene biguanide vaginal suppositories
Sponsors
AGUNCO Obstetrics and Gynecology Centre
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial vaginosis | 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 | 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 | 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 | 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) |
Countries
Italy
Outcome results
None listed