Prophylactic Antibiotic Treatment During Vaginal Repair

Overview

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.

Full Title of Study: “Antibiotikaprofylakse Ved Vaginalplastik”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double

Interventions

  • Drug: Cefuroxime

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.
  • Gender Eligibility: Female

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Hvidovre University Hospital
    • Overall Official(s)
      • Marianne Ottesen, M.D, Ph.D, Study Director, Hvidovre University Hospital
    • Overall Contact(s)
      • Marianne Ottesen, M.D, 0045 36323632, marianne.8sen@dadlnet.dk

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