Overview

Prophylactic Antibiotic Treatment During Vaginal Repair

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hvidovre University Hospital
Treatments:
Anti-Bacterial Agents
Cefuroxime
Cefuroxime axetil
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.