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

Sponsor

AGUNCO Obstetrics and Gynecology Centre (Other)

Overall Status

Completed

CT.gov ID

NCT01740245

Collaborator

(none)

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Antisepsis Regimen After Surgical Treatment of HPV Infected Lesions	Device: Chlorhexidine vaginal suppositories Device: Polyhexamethylene biguanide vaginal suppositories	Phase 4

Study Design

Study Type:

Interventional

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Chlorhexidine	Device: Chlorhexidine vaginal suppositories
Experimental: Polyhexamethylene biguanide	Device: Polyhexamethylene biguanide vaginal suppositories

Arm

Intervention/Treatment

Active Comparator: Chlorhexidine

Device: Chlorhexidine vaginal suppositories

Experimental: Polyhexamethylene biguanide

Device: Polyhexamethylene biguanide vaginal suppositories

Outcome Measures

Primary Outcome Measures

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)
Bacterial vaginosis [After six weeks by the day of laser treatment]
Diagnosis is performed according to the Amsel's criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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