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

November 30, 2012 updated by: AGUNCO Obstetrics and Gynecology Centre

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00132
        • Agunco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacterial vaginosis
Time Frame: After three weeks by the day of the laser treatment
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
Time Frame: At weekly intervals by the day of laser treatment
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
Time Frame: 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)
At weekly intervals by the day of laser treatment
Change from baseline irritation status at 6 weeks
Time Frame: 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)
At weekly intervals by the day of laser treatment
Bacterial vaginosis
Time Frame: After six weeks by the day of laser treatment
Diagnosis is performed according to the Amsel's criteria
After six weeks by the day of laser treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGUNCO Obstetrics and Gynecology Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 28, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Estimate)

December 4, 2012

Last Update Submitted That Met QC Criteria

November 30, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHX-PHMB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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