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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

Tracking Information
First Submitted Date  ICMJE November 28, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date December 4, 2012
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November¬†30,¬†2012)
  • 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
  • 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)
  • 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)
  • 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)
  • Bacterial vaginosis [ Time Frame: After six weeks by the day of laser treatment ]
    Diagnosis is performed according to the Amsel's criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antisepsis Regimen in the Surgical Treatment of Human Papilloma Virus Generated Cervical Lesions: Polyhexamethylene Biguanide Versus Chlorhexidine
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Not Provided
Condition  ICMJE Antisepsis Regimen After Surgical Treatment of HPV Infected Lesions
Intervention  ICMJE
  • Device: Chlorhexidine vaginal suppositories
  • Device: Polyhexamethylene biguanide vaginal suppositories
Study Arms  ICMJE
  • Active Comparator: Chlorhexidine
    Intervention: Device: Chlorhexidine vaginal suppositories
  • Experimental: Polyhexamethylene biguanide
    Intervention: Device: Polyhexamethylene biguanide vaginal suppositories
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01740245
Other Study ID Numbers  ICMJE CHX-PHMB
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AGUNCO Obstetrics and Gynecology Centre
Study Sponsor  ICMJE AGUNCO Obstetrics and Gynecology Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AGUNCO Obstetrics and Gynecology Centre
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP