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

Study Overview
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Brief Summary
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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.

Conditions
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Antisepsis Regimen After Surgical Treatment of HPV Infected Lesions

Intervention / Treatment
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* Device: Chlorhexidine vaginal suppositories
* Device: Polyhexamethylene biguanide vaginal suppositories


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chlorhexidine<br> | Device: Chlorhexidine vaginal suppositories<br> <br> |
| Experimental: Polyhexamethylene biguanide<br> | Device: Polyhexamethylene biguanide vaginal suppositories<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial vaginosis | Diagnosis of eventual bacterial infection is performed according to Amsel's criteria | After three weeks by the day of the laser treatment | 
| 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 | 
| 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 | 
| 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 | 
| Bacterial vaginosis | Diagnosis is performed according to the Amsel's criteria | After six weeks by the day of laser treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser therapy, Cervical lesions, Polyhexamethylene biguanide, Chlorhexidine