Prophylactic Antibiotic Treatment During Vaginal Repair
Information source: Hvidovre University Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Uterine Prolapse; Cystocele; Rectocele; Enterocele
Intervention: Cefuroxime (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Hvidovre University Hospital Official(s) and/or principal investigator(s):
Marianne Ottesen, M.D, Ph.D, Study Director, Affiliation: Hvidovre University Hospital
Overall contact:
Marianne Ottesen, M.D, Phone: 0045 36323632, Ext: 3540, Email: marianne.8sen@dadlnet.dk
Summary
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.
Clinical Details
Official title: Antibiotikaprofylakse Ved Vaginalplastik
Study design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment
Primary outcome: primary endpoint: no infections (urinary tract infections, pneumonia,wound infections, infected haematomas, etc.) within 30 days postoperatively
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Marianne Ottesen, M.D, Phone: 0045 36323632, Ext: 3540, Email: marianne.8sen@dadlnet.dk
Hvidovre University Hospital, Hvidovre 2650, Denmark; Recruiting
Marianne Ottesen, M.D, Phone: 0045 36323632, Ext: 3540, Email: marianne.8sen@dadlnet.dk
Tina Olsen, M.D, Sub-Investigator
Abelone Elisabeth Sakse, M.D, Sub-Investigator
Marianne Ottesen, M.D, PhD, Principal Investigator
Additional Information
Starting date: May 2005
Last updated: September 8, 2006
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