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

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ClinicalTrials.gov Identifier: NCT01740245
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
AGUNCO Obstetrics and Gynecology Centre

Study Description
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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
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Study Type : Interventional  (Clinical Trial)

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Chlorhexidine Device: Chlorhexidine vaginal suppositories
Experimental: Polyhexamethylene biguanide Device: Polyhexamethylene biguanide vaginal suppositories


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740245


Locations
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Italy
AGUNCO
Rome, Italy, 00132
Sponsors and Collaborators
AGUNCO Obstetrics and Gynecology Centre
More Information
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Publications:

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Responsible Party: AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier: NCT01740245    
Other Study ID Numbers: CHX-PHMB
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: June 2012
Keywords provided by AGUNCO Obstetrics and Gynecology Centre:
Laser therapy
Cervical lesions
Polyhexamethylene biguanide
Chlorhexidine
Additional relevant MeSH terms:
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Biguanides
Chlorhexidine
Polihexanide
Anti-Infective Agents, Local
 Anti-Infective Agents
Disinfectants
Hypoglycemic Agents
Physiological Effects of Drugs