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OpenTrials
Completed

NCT Number: NCT01740245

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

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.

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Key information

Conditions

Antisepsis Regimen After Surgical Treatment of HPV Infected Lesions

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

AGUNCO

Rome, 00132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine vaginal suppositories

Device

Polyhexamethylene biguanide vaginal suppositories

Device

Primary outcomes

  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. Bacterial vaginosis

    Time frame: After six weeks by the day of laser treatment

    Diagnosis is performed according to the Amsel's criteria

Sponsors and collaborators

Lead sponsor

AGUNCO Obstetrics and Gynecology Centre

Other

Registry information

Important dates

First posted
Dec 4, 2012
Registry last updated
Dec 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.