Antisepsis Regimen in the Surgical Treatment of Human Papilloma Virus Generated Cervical Lesions: Polyhexamethylene Biguanide Versus Chlorhexidine

AGUNCO Obstetrics and Gynecology Centre

Status and phase: Completed; Phase 4

Conditions: Antisepsis Regimen After Surgical Treatment of HPV Infected Lesions

Treatments: Device: Chlorhexidine vaginal suppositories; Device: Polyhexamethylene biguanide vaginal suppositories

Study type: Interventional

Funder types: Other

Identifiers

NCT01740245

CHX-PHMB

Details and patient eligibility

About

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.

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Chlorhexidine

Active Comparator group

Treatment:

Device: Chlorhexidine vaginal suppositories

Polyhexamethylene biguanide

Experimental group

Treatment:

Device: Polyhexamethylene biguanide vaginal suppositories