Prophylactic Antibiotic Treatment During Vaginal Repair

September 8, 2006 updated by: Hvidovre University Hospital

Antibiotikaprofylakse Ved Vaginalplastik

Prolapse of the uterus, bladder and rectum is a common condition in multiparous and/or elderly women. The number of operations for vaginal repair is increasing in Denmark, but there is no consensus or evidence found about the efficiency of prophylactic antibiotics intraoperatively concerning postoperative infections.

The objective of this randomized, controlled trial is to investigate the significance of prophylactic antibiotic treatment in vaginal repair operations.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

Phase

  • Not Applicable

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

  • Denmark
      • Hvidovre, Denmark, 2650
        • Recruiting
        • Hvidovre University Hospital
        • Contact:
        • Sub-Investigator:
          • Tina Olsen, M.D
        • Sub-Investigator:
          • Abelone Elisabeth Sakse, M.D
        • Principal Investigator:
          • Marianne Ottesen, M.D, PhD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women ages 18+ with uterine prolapse grade I - II and/or cystocele and/or rectocele and/or enterocele grade I - II and/or defects of the perineal body, in whom there is medical indication for vaginal repair, but no indication for vaginal hysterectomy or transvaginal suspension of the vaginal vault after prior hysterectomy.

Exclusion Criteria:

  • Patients allergic to cefuroxime.
  • Patients in whom a vaginal hysterectomy or a transvaginal suspension of the vaginal vault or other major surgery is planned, where prophylactic antibiotic treatment is standard.
  • Patients suffering from physical or mental disorders that will not allow them to give informed consent.
  • Pregnant and nursing women.

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?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
primary endpoint: no infections (urinary tract infections, pneumonia,wound infections, infected haematomas, etc.) within 30 days postoperatively

Collaborators and Investigators

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

Sponsor

Hvidovre University Hospital

Investigators

  • Study Director: Marianne Ottesen, M.D, Ph.D, Hvidovre University Hospital

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 Major Dates

Study Start

May 1, 2005

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

September 11, 2006

Last Update Submitted That Met QC Criteria

September 8, 2006

Last Verified

February 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2602-415

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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