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Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection

NCT03099863 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2021-12-30

Study results available
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Summary

Postoperative urinary tract infections (UTIs) affect 20-30% of patients undergoing elective gynecologic surgery and have a significant socioeconomic impact and cost. Preoperative antibiotics, sterile operating techniques, postoperative antibiotic and non-antibiotic medical therapies have been utilized to attempt to decrease this rate with little improvement. Utilization of an intraoperative antibiotic cystoscopic irrigant may decrease postoperative UTIs. The investigators have designed a prospective randomized controlled study to evaluate the effectiveness of an antibiotic cystoscopic fluid in preventing postoperative urinary tract infections in women undergoing elective pelvic floor surgery with cystoscopy.

Conditions

Interventions

DRUG

Cystoscopic Fluid containing Neosporin G. U. Irrigant

Normal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL

PROCEDURE

Cystoscopy

Diagnostic cystoscopy performed during pelvic floor surgery

DRUG

Cystoscopic Fluid/Placebo

Normal saline cystoscopic fluid

Sponsors & Collaborators

  • MetroHealth Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03099863 on ClinicalTrials.gov