Prophylactic Antibiotic Treatment During Vaginal Repair

This study is currently recruiting participants.

Verified by Hvidovre University Hospital, February 2005

First Received: September 9, 2005 Last Updated: September 8, 2006 History of Changes

Sponsor:	Hvidovre University Hospital
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00162604

Purpose

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.

Condition	Intervention
Uterine Prolapse Cystocele Rectocele Enterocele	Drug: Cefuroxime

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:	Antibiotikaprofylakse Ved Vaginalplastik

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Bladder Diseases Pelvic Support Problems

Drug Information available for: Cefuroxime Cefuroxime sodium Cefuroxime axetil

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	May 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162604

Contacts

Contact: Marianne Ottesen, M.D

0045 36323632 ext 3540

marianne.8sen@dadlnet.dk

Locations

Denmark
Hvidovre University Hospital	Recruiting
Hvidovre, Denmark, 2650
Contact: Marianne Ottesen, M.D 0045 36323632 ext 3540 marianne.8sen@dadlnet.dk
Sub-Investigator: Tina Olsen, M.D
Sub-Investigator: Abelone Elisabeth Sakse, M.D
Principal Investigator: Marianne Ottesen, M.D, PhD

Sponsors and Collaborators

Hvidovre University Hospital

Investigators

Study Director:

Marianne Ottesen, M.D, Ph.D

Hvidovre University Hospital

More Information

No publications provided

Study ID Numbers:	2602-415
Study First Received:	September 9, 2005
Last Updated:	September 8, 2006
ClinicalTrials.gov Identifier:	NCT00162604 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Hvidovre University Hospital:

Prophylactic antibiotic
Postoperative infections
Uterine prolapse grade I - II
cystocele

rectocele
enterocele
defects of the perineal body

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Anti-Infective Agents
Rectocele
Cystocele
Uterine Prolapse
Gastrointestinal Diseases
Urinary Bladder Diseases
Uterine Diseases
Intestinal Diseases
Prolapse

Rectal Diseases
Pharmacologic Actions
Genital Diseases, Female
Anti-Bacterial Agents
Cefuroxime
Digestive System Diseases
Urologic Diseases
Therapeutic Uses
Hernia

ClinicalTrials.gov processed this record on February 09, 2010